Huntington Study Group clinical and observational trials
that have completed enrollment:
DIMOND
DOMINO
PHAROS
Pilot Safety Study of Coenzyme Q10
PHEND-HD
TREND-HD
DIMOND [A Multi-Center, Phase 1-2A, Open-Label, Dosage-Escalation and Randomized, Double-Blinded, Placebo-Controlled Study of Dimebon in Subjects With Huntington’s Disease]
...ENROLLMENT FOR THIS STUDY HAS BEEN COMPLETED...
If you are interested in learning more about this study, please contact the Huntington Study Group toll free at 1-, or see the January 2008 Article on the HDSA web site, the July 2007 DIMOND press release, and the October 2006 DIMOND press release. A DIMOND Participating Site List is also available.
DOMINO [A Multi-Center, Double-Blind, Pilot Study of Minocycline in Huntington’s Disease]
...ENROLLMENT FOR THIS STUDY HAS BEEN COMPLETED...
The Huntington Study Group (HSG), under the direction of Merit Cudkowicz MD, MSc (Massachusetts General Hospital) and Karl Kieburtz MD, MPH (University of Rochester), is conducting a multi-center, randomized, double-blind study of minocycline in individuals with Huntington’s 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 will assess the safety and tolerability of minocycline over a longer period of use by enrolling 100 subjects, age 18 or older with manifest HD, who will be followed approximately every three months for a total of 18 months. Please refer to the DOMINO Participating Site List for a site in your area.
For information about DOMINO found on the ClinicalTrials.gov web site, please go to DOMINO.
PHAROS: Prospecitve Huntington At Risk Observataional Study
...ENROLLMENT FOR THIS STUDY HAS BEEN COMPLETED...
PHAROS aims to define the natural history and experiences of people who are at risk of developing HD and who do not know their gene status. The HSG research sites have enrolled 1001 individuals.
The PHAROS project is an observational study in North America (US and Canada) of people ages 26-55 who are at risk for Huntington's Disease and have never been tested for the HD gene. During the study, subjects will be evaluated every nine (9) months (for a minimum of 3 years) using a clinical survey known as the Unified Huntington's Disease Rating Scale (UHDRS),which looks at movement, psychological and behavioral function.
Pilot Safety and Tolerability Study of Coenzyme Q10 in Huntington's Disease and in Normal Subjects
...ENROLLMENT FOR THIS STUDY HAS BEEN COMPLETED...
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 participants 18 years of age or older - 20 with early manifest HD and 10 healthy persons without HD.
Participating sites included the Institute for Neurodegenerative Disorders, Massachusetts General Hospital, University of Rochester, and Wake Forest University.
PHEND-HD - Phenylbutyrate Development for Huntington’s Disease: A Multi-center, Double-Blind, Placebo-Controlled Study with Open-Label Follow-Up to Determine the Safety & Tolerability of Phenylbutyrate in Subjects with Huntington’s Disease
...ENROLLMENT FOR THIS STUDY HAS BEEN COMPLETED...
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) is conducting a multi-center, double-blind, placebo-controlled study with open-label follow-up of phenylbutyrate. PHEND-HD is designed to assess and gather information on the safety and tolerability of phenylbutyrate. This study will recruit subjects who are 18 years of age or older with a clinical diagnosis of HD. The study will last approximately 20 weeks for each subject.
For a participating site near you, please go to the PHEND-HD participating site list.
For information about PHEND-HD found on the ClinicalTrials.gov web site, please go to PHEND-HD.
For further information on the study, contact:
Steven M. Hersch, MD, PhD
Principal InvestigatorMassachusetts General Hospital
Huntington Study Group
University of Rochester
TREND-HD: A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Trial of Ethyl-EPA (Miraxion™) in Subjects with Mild to Moderate Huntington’s Disease
The TREND-HD participating site list is available.
The Huntington Study Group (HSG) is conducting a study of the research medication ethyl-EPA in persons 35 years of age or older who have mild to moderate Huntington’s disease (HD). TREND-HD is 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 are 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. The study is sponsored by Amarin Neurosciences in Scotland, U.K, a subsidiary of Amarin Corp., PLC in London.
For further information, see the and the (April 2007) TREND-HD Press Release.
For information about TREND-HD found on the ClinicalTrials.gov web site, please go to TREND-HD.