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  Completed Clinical Trials

The mission of the HSG is to find effective treatments for HD by conducting well designed clinical trials for patients and families. Since 1993, the HSG has carried out 22 clinical and observational studies. There have been over 10,000 participants willing to provide informed consent and contribute their time to our HD knowledgebase. The HSG has received diverse support for these trials including government, pharmaceutical companies and private foundations.

Please also refer to the HSG Publications List for a full list of HSG study publication information.

An HSG clinical trial is considered 'completed' after the data collected during a study is compiled, analyzed and transformed into manuscript form (or a research article) and submitted to a peer-reviewed journal for publication.

The Completed HSG Clinical Trials are listed below (starting with the most recently completed trial at the top):

HORIZON

COHORT

PHAROS

RESPOND-HD

DIMOND

DOMINO
PHEND-HD
TREND-HD
TETRA-HD
Coenzyme Q10 Pilot Study
MINO
Creatine in Huntington's Disease
RID-HD
CARE-HD
START-HD
CAG Laboratory Studies Based on INTRO-HD
Basic Science Investigations Based on INTRO-HD
INTRO-HD 


A Phase III, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Dimebon in Patients with Mild-To-Moderate Huntington Disease

 

Under the direction of Karl Kieburtz, MD, MPH, Principal Investigator (University of Rochester), and Bernhard Landwehrmeyer, MD, co-Principal Investigator (University of Ulm), the Huntington Study Group (HSG), and the European Huntington’s Disease Network (EHDN) are conducting a global collaborative multi-center, randomized, double-blind, placebo-controlled study of Dimebon in individuals with mild-to-moderate Huntington disease (HD).  The purpose of the study is to assess the safety and efficacy of Dimebon 60 mg per day, when taken over a period of 6 months. Efficacy is determined by exploring whether or not there is an effect on cognitive (thinking) abilities and overall functioning in people with HD.  The study will also evaluate other HD symptoms including behavioral and motor (movement) symptoms.  Approximately 60 research centers across North America, Europe, and Australia, will enroll approximately 350 individuals.

Dimebon is an experimental drug.  Research has shown that Dimebon might be effective in preventing the death of brain cells in animals and improving thinking and memory in Alzheimer disease.  Results of a HD study in the United States and United Kingdom showed that Dimebon 60mg per day was safe and well tolerated and suggested that Dimebon may improve cognition (thinking abilities) in individuals with HD.

This study is being sponsored by Medivation, Inc in collaboration with Pfizer, Inc.

For more information: call the Huntington Study Group toll-free number (United States and Canada): 1-800-487-7671 

For more information: call the European Huntington’s Disease Network: +44 7791 985313 or fax +49 731 5006 3082 or visit the website at www.euro-hd.net
 

Please see the HORIZON participating site list. HORIZON research sites and their contact information will be added frequenly to this list. Please check back. Thank you.

Related Documents:
HORIZON Participating Site List 
May 2009 HORIZON Brochure
May 2009 HORIZON Study Site List


Related Links:
HORIZON Trial Web Site 
July 2009 Medivation Press Release
June 2009 - Interview with the HORIZON Principal Investigator, Karl Kieburtz
- By Marsha Miller, PhD


Cooperative Huntington’s Observational Research Trial (COHORT)

This long-term observational study will initially take place at  North American and Australian Huntington Study Group (HSG) sites.  The goal of COHORT is to collect information in order to learn more about HD, potential treatments, and to plan future research studies of experimental drugs aimed at postponing the onset or slowing the progression of HD.  This study will recruit individuals of any age who have clinically diagnosed features of HD in the setting of a confirmatory family history, adults, 18 years of age and older & older adolescents (15-17 years old) who are at-risk for developing HD and adults, 18 years of age and older that are part of an HD family. 

Individuals who choose to participate will have one study visit every year for as long as they are able and choose to participate, except for older adolescents, who will only have one study visit before the age of 18. Please refer to the COHORT Participating Site List for sites in your area.

 

At each visit, individuals participating in COHORT will be required to have a clinical evaluation. All subjects will have blood drawn for genetic testing of the CAG polymorphism and for other genetic changes, which may be important to Huntington’s disease.  All subjects will also be given the option to participate in the collection and storage of blood for future HD research.  For those who are 18 years of age and older, there will be optional research procedures including the collection of family history, HSG data linking,  contact between study visits, and future contact about HD research.
 

Data from the COHORT study will be collected in databases designed to protect the privacy of all those who participate.  The data and samples will provide researchers with a valuable resource to address a wide variety of research questions in Huntington’s disease.
 

To read more about the different aspects of the COHORT study, click the appropriate link:
Clinical Evaluation
Collection of Blood for Genetic Testing
Collection of Family History Information
Collection and Storage of Biological Samples for Future HD Research

Contact Between Study Visits

Participation in other Research Trials

Clinical Evaluation

Each year COHORT participants will undergo a medical and neurological evaluation.  This evaluation will include standardized assessments of movement, thinking, memory, ability to perform daily activities, and behavior.  Also, a medical and neurological examination will be conducted and the participant will provide information about medical history and current medications.  Older adolescents will not be asked to participate in the neurological and physical examination.  These individuals will have one study visit before the age of 18 and will be asked to re-consent as an adult once they reach the age of consent.

Collection of Blood for Genotyping

At the initial visit, all COHORT participants will have blood drawn for genotyping of the CAG polymorphism and for other genetic changes, which may be important to Huntington’s disease.  Since this genotyping will be experimental, neither the COHORT participants nor the site investigators will receive the results.

Collection of Family History Information (optional)

Family history data will be used to learn more about the natural history of the disease over several generations.  This information may uncover new details about why there are differences in how HD affects different families and different members within a family.  Any COHORT participant 18 years of age and older with a family history of HD will be asked to participate.  This part of the COHORT study is optional.  If the participant chooses not to provide family history information, he or she may still take part in the COHORT study.

The participant will be asked to complete a Family History Questionnaire (FHQ), which asks questions about the participant’s extended family, including:
• Family members’ names, birthdates, sex, and, if applicable, date of death
• For any affected family members, age of HD diagnosis and whether a physician made the diagnosis will be collected.

Collection and Storage of Biological Samples for Future HD Research (optional)

Scientists have found that blood, urine, and other biological samples contain clues about HD that may be used to better understand the progression of the disease and to develop new therapies.  Any COHORT participant will be given the option of having blood and urine collected and stored for future HD research.  If a participant chooses not to participate, he or she may still take part in the COHORT study.  These samples will be labeled with a unique identification code and stored in a research facility. 

 

These stored samples will provide researchers with the resources necessary to study Huntington’s disease.  Huntington’s disease researchers from institutions all over the world will be able to request samples for research in HD.  All samples will be identified with a code, and researchers will not receive any personally identifying information about COHORT participants.

Contact Between Study Visits (optional)

Throughout the study we will need to contact you to schedule the yearly study visits.  Although will be contacted regarding your study appointments, you have the option of being contacted between visits to collect additional information or to provide you with study updates.

Participation in other Research Trials

COHORT is not the only option for you to contribute to HD research.  As a COHORT participant you are also eligible to join other clinical trials if you meet enrollment criteria.  Currently, the Huntington Study Group has other HD trials recruiting.  Please click here to find out more details on studies that are recruiting participants.

 

Related Documents:
COHORT Participating Site List
2009 COHORT Brochure
2009 COHORT Older Adolescent Brochure
2009 COHORT Community Summer 2009 Newsletter
2009 COHORT Fact Sheet
2008 HD Clinical Research Symposium Abstract
2008 HD Clinical Research Symposium Poster
COHORT Community Spring 2008 Newsletter
2005 Press Release


Prospective Huntington At Risk Observational Study

PHAROS completed enrollment of 1001 research participants in January 2004. The study is expected to conclude in 2010. HSG sites participating in PHAROS are listed below.

What is the PHAROS Project?

PHAROS aims to define the natural history and experiences of adults who are at risk for developing HD and who choose not to learn their gene status.

The PHAROS project is an observational study in North America (US and Canada) of people ages 26-55 who are at risk for Huntington Disease and have chosen not to learn of their HD gene status through predictive DNA testing. Research participants have been evaluated about every nine (9) months, now for an average of about 5 years, using a variety of clinical tests and surveys examining movement, psychosocial and behavioral function.

A research blood sample was obtained at the beginning of the study to examine the HD and related genes. No one, including the investigators and research participants will ever learn about the individual results of these gene analyses. Samples are also being collected to look for biomarkers of DNA and RNA damage. 

Why is the HSG observing people at risk for Huntington Disease?

To date, little long-term (longitudinal) research has been done on individuals who are at risk for developing an inherited disease (such as a person who has a parent or sibling affected by HD). We hope this study will help us to answer some important questions, such as:

What are the earliest clinical signs of HD and when do they start?
How accurate are these measures in detecting the onset of HD?
What factors influence when a person carrying the HD gene develops signs and symptoms?
In a group of people at risk for HD, how many will develop signs of the illness over the multi-year period of observation?

We hope that this study may provide some essential information for future trials of experimental drugs for HD.

Who is enrolled in PHAROS?

Individuals:
Between 26-55 years of age;
Who are at risk for HD by virtue of having (or having had) a parent or sibling with the illness;
Who had never been tested for the HD gene, and who did not desire to be tested for the HD gene during the duration of the study; and
Who had never been diagnosed with HD.

How is confidentiality maintained in PHAROS?

Confidentiality is a central concern in the PHAROS study, and we have designed the study to protect the confidentiality of research subjects to the fullest extent possible. Names do not appear on the study forms - instead, a code number is assigned to identify research participants. A bar code (different from the subject code) is used to identify blood samples and any DNA results.

As mentioned previously, DNA results will not be provided to research participants or any of the physicians or staff at the site where the study is being conducted - instead, data will be transformed and sealed in a coded fashion (which does not identify individuals by name) and sent to a central secure location at the University of Rochester.

Could eligible persons participate if they did not want to learn their DNA results or whether they might be developing signs of HD?

Yes. Participants will never learn their DNA results through the PHAROS study, even when the study is complete. Participants can, if they later choose, arrange for DNA testing at an independent laboratory outside of the study. Research participants will also not be told if they are developing signs of HD. (If participants decide they do want to know this information, they will need to arrange for a clinical evaluation outside of the scheduled PHAROS study visits.)

Are there any risks to PHAROS participants?

Some psychological stress may occur from participation in PHAROS due to concern about showing signs of HD or carrying the HD gene. There are also some minor risks when blood is drawn for the blood sample. These risks are further explained in the consent form, and the research investigator or coordinator can also answer any questions.

What is the benefit of participating in PHAROS?

There is no direct health benefit from participating in PHAROS. However, participation may help to provide information useful for a better understanding of the onset of illness in unaffected persons at risk for HD.

How do I find out more information about the PHAROS Study?

As of January 2004, PHAROS completed enrollment. However, if you are interested in learning more about this study, please read our published articles

For a participating site near you, please go to our PHAROS Participating Site List.

For access to the PHAROS Participant Newsletters, please see PHAROS Newsletter Volume Listing below.


 PHAROS UPDATE - July 28, 2006

At Risk for Huntington Disease. 
The PHAROS (Prospective Huntington At Risk Observational Study) 
Cohort Enrolled
The Huntington Study Group PHAROS Investigators

The Huntington Study Group (HSG) PHAROS (Prospective Huntington At Risk Observational Study) investigators reported on the baseline characteristics of this remarkable cohort in the July 2006 issue of the Archives of Neurology (63:991-998). PHAROS is a multi-site, multi-year project that aims to gain knowledge about the early signs of Huntington disease (HD) onset and their relationship to environmental and genetic factors. PHAROS is also examining the psychosocial, ethical and practical issues involved in long-term study of adults at 50:50 risk to develop HD who have chosen not to undergo predictive genetic testing to learn of their gene-carrier status.

The PHAROS cohort of 1001 adults at risk for HD is mostly women (65%), well educated, and gainfully employed. At the start of the study, enrolled research participants were characterized as highly functional with minimal, if any, impairment of movement or intellect. Participants have enrolled in PHAROS mindful that the knowledge from this long-term study will help shape the efficient design and appropriate conduct of future clinical trials aimed at delaying the onset of illness in gene carriers who have not yet developed signs of HD. The knowledge from PHAROS will also inform us about how persons at high risk to develop a disabling genetic disease deal with lingering uncertainties about their future health and complex choices about their participation in research.


Related Documents:
PHAROS Participant Thank you Letter August 2009
PHAROS Participating Site List
PHAROS Newsletter Volume 1, 2004
PHAROS Newsletter Volume 2, January 2005
PHAROS Newsletter Volume 3, July 2005
PHAROS Newsletter Volume 4, March 2006
PHAROS Newsletter Volume 5, August 2006
PHAROS Newsletter Volume 6, March 2007 
PHAROS Newsletter Volume 7, December 2007 
PHAROS Newsletter Volume 8, June 2008
Huntington Project Research Spotlight report 'Review of Published Article-At Risk for Huntington Disease: The PHAROS Cohort Enrolled-', July 2007

Related Links:
July 2006 issue of the Archives of Neurology (63:991-998)


RESPOND-HD: An Examination of Responses to Potential Discrimination from Individuals At Risk for Huntington Disease

The RESPOND-HD observational trial is evaluating issues of potential discrimination as perceived by those persons affected by Huntington disease (HD). The information gathered in this study will allow researchers to examine the experiences of persons who have undergone genetic testing for HD or those persons who are at risk for HD. RESPOND-HD will seek answers to questions such as “How is knowledge used after genetic testing?”, “What experiences occur following genetic testing?” and “Why might outcomes differ in persons undergoing genetic testing?”. Study participants from the PHAROS and PREDICT-HD research trials were being recruited for this study.

 

Participants for this international, multi-site study were recruited from domestic geographical areas with differing discrimination laws for employment and insurance and from foreign sites where health care systems may be different from those in domestic sites.

Related Link: University of Iowa RESPOND-HD Study Information


DIMOND: A Multi-Center, Phase 2, Randomized, Double-Blinded, Placebo-Controlled Study of Dimebon in Subjects with Huntington Disease

The Huntington Study Group (HSG) conducted a study of the research medication dimebon in persons 29 years of age or older who had mild to moderate Huntington disease (HD).  DIMOND was designed to determine safe and tolerable doses of dimebon and also to determine the effect of dimebon on cognitive (thinking) and motor (movement) signs and overall functioning of subjects with HD. Sixteen research centers in the United States and one research center in the United Kingdom enrolled 91 research subjects. The time on study drug was 3 months. The study enrolled research subjects with early to moderate signs of HD who were independently ambulatory (walking) and self-sufficient in activities of daily living, such as eating, dressing, and bathing.  Enrollment began in the Summer of 2007, and was completed in March 2008.  The study was sponsored by Medivation, Inc.

 

For further information please contact the Huntington Study Group toll free (from the US and Canada) at 1-800-487-7671.

 

Related Documents:
DIMOND Participating Site List
July 2007 DIMOND Press Release
October 2006 DIMOND Press Release

Related Links: 
March 2009 Poster Presentation "The Safety and Efficacy of Dimebon in Mild-to-Moderate Huntington's Disease: A Multicenter, Phase 2, Randomized, Placebo-Controlled Trial (DIMOND)", 9th International Conference AD/PD 2009 in Prague, Czech Republic
July 2008 Medivation Press Release About the DIMOND Top-Line Results
July 2008 Commentary by Marsha Miller, PhD about Medivation's Top-Line Results Press Release
ClinicalTrials.gov
January 2008 HDSA DIMOND News Article by Marsha Miller, PhD


DOMINO: A Multi-Center, Double-Blind, Pilot Study of Minocycline in Huntington Disease

The Huntington Study Group (HSG), under the direction of Merit Cudkowicz MD, MSc (Massachusetts General Hospital) and Karl Kieburtz MD, MPH (University of Rochester), conducted a multi-center, randomized, double-blind study of minocycline in individuals with Huntington disease (HD) to assess long-term safety and to gather more information on its possible efficacy. Minocycline is a drug that has been used for the past 30 years to treat a variety of infections. Minocycline also has anti-cell death and anti-oxidant properties and may have potential therapeutic benefit in HD. Recent studies in a mouse model of HD have demonstrated that minocycline helps to slow down the clinical onset of HD and prolongs life. In a previous HSG trial led by Drs. Cudkowicz, Frederick Marshall and Robert Friedlander, minocycline was shown to be safe and tolerable in HD patients at doses of 100 mg and 200 mg per day over 8 weeks of use [Neurology 2004: 63:547-549].

The DOMINO study assessed the safety and tolerability of minocycline over a longer period of use by enrolling 100 subjects, age 18 or older with manifest HD, who were followed approximately every three months for a total of 18 months. Enrollment for DOMINO was completed in May 2007. Please refer to the documents and links below for more information.

Related Documents:
DOMINO Participating Site List
2007 DOMINO Brochure


Related Links:
ClinicalTrials.gov
DOMINO Results (April 2009)


PHEND-HD: Phenylbutyrate Development for Huntington Disease - Multi-center, Double-Blind, Placebo-Controlled Study with Open-Label Follow-Up to Determine the Safety & Tolerability of Phenylbutyrate in Subjects with Huntington Disease

The Huntington Study Group (HSG), under the direction of Steven M. Hersch, MD, PhD (Massachusetts General Hospital) and Karl Kieburtz, MD, MPH (University of Rochester) conducted a multi-center, double-blind, placebo-controlled study with open-label follow-up of phenylbutyrate. The study was funded by National Institutes of Neurological Disorders and Stroke and HP Therapeutics. PHEND-HD was designed to assess and gather information on the safety and tolerability of phenylbutyrate. This study recruited subjects who are 18 years of age or older with a clinical diagnosis of HD. The study enrolled 63 subjects who were on study medication for 20 weeks. Recruitment for the PHEND-HD study was initiated on June 30, 2005 and completed in January 2006.


For further information on the study, contact:

Steven M. Hersch, MD, PhD
Principal Investigator
Massachusetts General Hospital
Boston, MA 02129
(617) 726-5892
 

Huntington Study Group
University of Rochester
Rochester, NY 14620
(800) 487-7671

 

Related Links: 
ClinicalTrials.gov

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TREND-HD: A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Trial of Ethyl-EPA (Miraxion™) in Subjects with Mild to Moderate Huntington Disease

The Huntington Study Group (HSG) conducted a study of the research medication ethyl-EPA in persons 35 years of age or older who had mild to moderate Huntington disease (HD). TREND-HD was designed to determine the effect of ethyl-EPA on the motor (movement) signs and symptoms of HD. In this 12-month study, 43 sites in the United States and Canada enrolled 316 research subjects with early signs of HD who were independently ambulatory (walking) and fully self-sufficient in activities of daily living, such as eating, dressing, and bathing. Enrollment began in the summer of 2005, and was completed in August 2006. The study was sponsored by Amarin Neurosciences in Scotland, U.K, a subsidiary of Amarin Corp., PLC in London.

 

For further information about the study, please contact the HSG toll free at 800-487-7671.
 

December 2008 TREND-HD Update: 
The HSG announces the publication of two articles pertaining to the TREND-HD study:

Article 1: Randomized Controlled Trial of Ethyl-EPA in HD
Article 2: Communicating Clinial Trial Results to Research Participants

Both above articles were published in the Archives of Neurology Journal on December 8, 2008. Also, below are some links to information relating to these reports:

Huntington Study Group Press Release
National Public Radio Report
University of Rochester Press Release
USA Today News Article

Related Documents:
April 2007 Press Release
June 2005 Press Release

Related Links: 
ClinicalTrials.gov

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TETRA-HD: A Randomized, Double-Blind, Placebo-Controlled, Study of Tetrabenazine for the Treatment of Huntington's Chorea

The Huntington Study Group (HSG), under the direction of Frederick Marshall, MD (University of Rochester), conducted a multi-center, double-blind, placebo-controlled study of tetrabenazine. TETRA-HD was designed to assess and gather information on the optimal dosage of tetrabenazine. The HSG recruited more than 70 participants who were 18 years of age or older and who had chorea as a significant feature of their HD. Recruitment for TETRA-HD was completed in December 2003. The study lasted for approximately 15 weeks for each study subject. At the end of the trial, patients were offered the option to continue treatment for an additional 6 to 12 months. The study was sponsored by Prestwick Pharmaceuticals.
 

For further information about the study, please contact the HSG toll free at 800-487-7671.
 

Related Documents: 

News Article - February 24, 2009 - New Drug Treats Crippling Symptom of Huntington's Disease
FDA News - FDA Approves First Drug for Treatment of Chorea in Huntington’s Disease - August 15, 2008
University of Rochester Press Release - August 15, 2008
HDSA Web Site Tetrabenazine Article - August 15, 2008
Prestwick (study sponsor) Xenazine (tetrabenazine) Web Site Information
Huntington Project Research Spotlight report 'Review of Published Article-Tetrabenazine as Antichorea Therapy in Huntington Disease-', October 2007
February 2006 TETRA-HD Press Release
November 2004 Results of TETRA-HD
August 2003 TETRA-HD Press Release

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Pilot Safety and Tolerability Study of Coenzyme Q10 in Huntington Disease and in Normal Subjects (Pre-2CARE)

The Huntington Study Group, under the direction of Karl Kieburtz, MD, MPH (University of Rochester), and Merit Cudkowicz MD, MSc (Massachusetts General Hospital), conducted an open-label study to assess and gather information on the safety and tolerability of coenzyme Q10. This study recruited 20 participants who were 18 years of age or older, with early manifest HD and also healthy persons without HD. Recruitment was completed in January 2004. The study was sponsored by the High Q Foundation.
 

For further information about the study, please contact the HSG toll free at 800-487-7671.

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MINO: Minocycline Dosing and Safety in Huntington Disease

The Huntington Study Group, under the direction of Merit Cudkowicz, MD (Massachusetts General Hospital), Robert Friedlander, MD (Harvard University) and Frederick Marshall, MD (University of Rochester), was awarded funding from the US Food and Drug Administration's Orphan Drug Products Division, the Huntington's Disease Society of America, and the Hereditary Disease Foundation for a multi-center, double-blind, placebo-controlled study of minocycline. The study was designed to assess and gather information on the safety and tolerability of minocycline. This study recruited participants who were 18 years of age or older and who had early manifest HD. The study enrolled 63 subjects between March 4, 2002 and November 7, 2002.

 

For further information about the study, please contact the HSG toll free at 800-487-7671.
 

Related Documents: 
MINO informational piece from Dr. Cudkowicz

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Creatine in Huntington Disease

Under the direction of Karl Kieburtz, MD (University of Rochester) a pilot study was undertaken at the University of Rochester, Ohio State University and Westmead Hospital (Australia). This was an initial study to evaluate and obtain information on the safety and feasibility of creatine, which may have an effect on cellular energy and oxidative stress in neurons of the brain. The study enrolled 50 subjects between July 19, 1999 and January 21, 2000. The study was sponsored by the Huntington's Disease Society of America.
 

For further information about the study, please contact the HSG toll free at 800-487-7671.

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RID-HD: Riluzole Dosing in HD

In September 1999, the HSG received funding from the US Food and Drug Administration's Orphan Products Division for a multicenter placebo controlled study of riluzole under the principal direction of Frederick Marshall, MD at the University of Rochester and Merit Cudkowicz, MD at Massachusetts General Hospital. The "Riluzole Dosing in HD" (RID-HD) study was designed to assess riluzole's short-term impact on motor, cognitive and behavioral symptoms of HD and to gather information on the safety and tolerability of riluzole. Enrollment of 63 subjects in RID-HD began in January 2000 and was completed in August 2000. The results of RID-HD trial were presented at the 19th International Meeting of the World Federation of Neurology Research Group on Huntington's Disease, August 25-28, 2001, Copenhagen, Denmark.
 

For further information about contact the HSG toll free at 800-487-7671.

 

Related Documents: 
RID informational piece from Dr. Marshall

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CARE-HD: Co-enzyme Q10 And Remacemide Evaluation in Huntington Disease

Under the leadership of Karl Kieburtz, MD (University of Rochester) and Walter Koroshetz, MD (Massachusetts General Hospital), the HSG's application for this multi-center study was funded in 1997 (NS 35284) by the National Institute of Neurologic Disorders and Stroke (NINDS) of the NIH. In preliminary studies conducted by HSG participants, co-enzyme Q10 and remacemide have been examined in HD patients. This study evaluated the naturally occurring substance CoQ10, which is important in the powerhouse of all cells (mitochondria) for normal energy transmission and remacemide that blocks glutamate receptors and may potentially have some value is slowing the progression of HD. Enrollment in the CARE-HD trial began in July 1997 and was completed in June 1998. Research participants were evaluated over a 2.5 year period and the last subject completed the trial in the fall of 2000.

For further information about the study, please contact the HSG toll free at 800-487-7671.
 

Related Documents: 
CARE-HD Results

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START-HD: Short Term Assessment of Remacemide Tolerability-HD

Under the leadership of Karl Kieburtz, MD and Andrew Feigin, MD and sponsored by Fisons Pharmaceuticals, START-HD was the first placebo-controlled study to evaluate the safety and tolerability of remacemide, a glutamate antagonist in patients with early Huntington disease. There were 31 subjects enrolled at the University of Rochester who were randomized to receive either placebo or active remacemide. A full report of START-HD was published in Movement Disorders (vol. 11:273-277,1996).
 

For further information about the study, please contact the HSG toll free at 800-487-7671.

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CAG Laboratory Studies Based on INTRO-HD

The HSG obtained blood samples from participating subjects in the INTRO-HD trial to examine the relationship between DNA (CAG repeat lengths of the HD IT-15 gene) and the phenotypic features of HD. Analyses are in progress to help define the relationship between the CAG repeat length and clinical progression of HD.

In the INTRO-HD trial, we also examined possible CAG repeat length variability among four research laboratories at Emory University, Johns Hopkins, Massachusetts General Hospital and University of British Columbia to determine the reliability of these measures in our research studies. Our analyses (Neurology 1996; 46:A258) indicated a remarkable degree of inter-laboratory agreement in CAG repeat length measurements among these four research laboratories, but the clinician must still weigh all available evidence before confirming HD gene-carrier status. The findings from this analysis may also have practical implications for pre-symptomatic HD testing.

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Basic Science Investigations Based on INTRO-HD

Through the development of the INTRO-HD trial and the support from Otsuka America Pharmaceutical, Inc. the HSG carried out studies of OPC-14117 in experimental animals in the laboratories of J. Timothy Greenamyre, MD, PhD (Emory University), Roger Albin, MD (University of Michigan), and Flint Beal, MD (formerly at Massachusetts General Hospital).

Flint Beal, MD, and his co-workers at Massachusetts General Hospital also examined the cerebrospinal fluid (CSF), serum and urine of INTRO-HD subjects to identify possible in vivo markers of oxidative stress. High priorities of the HSG are to develop reliable neurological markers of HD onset and progression and to test promising experimental interventions in genetic animal models of HD.

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INTRO-HD: Investigation of Tolerability in a Randomized Trial of OPC-14117 in HD

Led by Ira Shoulson, MD, and sponsored by Otsuka America Pharmaceutical, Inc. (Rockville, MD) INTRO-HD was the first HSG multi-center trial to examine the safety of the experimental antioxidant OPC-14117 in patients with manifest HD. INTRO-HD included a total of 64 research subjects who, during this 20-week trial, were administered tablets of OPC-14117 (at one of three dosages) or matching placebo. Participating sites included Columbia University in New York, Emory University in Atlanta, the University of California in San Diego, and the University of Rochester. Enrollment in the trial began in November 1994, and the follow-up was completed in September 1995. A full report of INTRO-HD was published in Neurology (vol. 50:1366-73, 1998).

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