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 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):

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

last updated: July 2009

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.

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

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

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.

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.

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

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.

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

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.

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.

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.

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.

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).


Home Clinical Research Clinical Trials/Observational Studies in Progress 2CARE COHORT CREST-E DIMOND HART HORIZON PHAROS PREDICT-HD PREQUEL RESPOND-HD Completed Clinical Trials HSG Research Sites Request for Proposals About Us HSG Overview HSG Executive Committee HSG Working Groups Standing HSG Committees Becoming an HSG Research Site Education Resources Login FAQ's Clinical Care UHDRS Links Publications News & Events Events & Upcoming Meetings PSG/HSG Symposium Huntington Disease Clinical Research Symposium Giving Contact Us	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 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): 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 last updated: July 2009 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 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 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 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. 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 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. 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 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 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. 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. 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. 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).