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H H D D I I N N S S I I G G H H T T S S TM Clinical Trials Status Report SPONSOR STUDY AGENT PHASE New York Medical College Tetrabenazine IV National Institute of Neurological Disorders and Stroke Coenzyme Q10 III Auspex Pharmaceuticals, Inc. SD-809 Extended Release III National Center for Complementary and Alternative Medicine Creatine III Assistance Publique Hôpitaux de Paris Olanzapine, Tetrabenazine and Tiapride III Raptor Pharmaceuticals Cysteamine Bitartrate Delayed-release Capsules (RP103) II/III National Institutes of Health Creatine II PRINCIPAL INVESTIGATOR, CONTACT DESIGN Robert Fekete, MD 914-594-4293 Prospective case-control study to compare Stroop Visual Interference Scores while individuals who are already taking tetrabenazine are off the drug for three days and then back on the drug Randomized double-blind study to see Merit Cudkowicz, whether coenzyme Q10 is effective in slowing MD, MSc Samuel Frank, MD Randomized double blind study to determine whether SD-809 ER tablets are effective in the treatment of chorea associated with HD 800-487-7671 Randomized double blind study to test whether high-dose creatine can slow the progressive functional decline that occurs in adult persons with early clinical features of HD Anne-Catherine Randomized controlled study to compare the Bachoud Levi, PhD beneficial and adverse effects of 3 different neuroleptics in HD +33 (0)1 49 81 23 01 5 years 2 years 3 years Coenzyme Q10 II Charite University Epigallocatechin Gallate II Pridopidine II STATUS 1 site Currently enrolling Terence Cardinal Cooke Health Care Center 49 sites Enrollment U.S., complete, active Canada, study Australia 1 site Currently enrolling Baylor College of Medicine 52 sites Currently enrolling U.S., Canada, Australia, New Zealand 1 site Europe Currently enrolling Christophe Verny, Double-blind, placebo-controlled study to be followed by an open-label extension study MD 18 months 8 total France Enrollment complete, results pending Diana Rosas, MD, Open label, single group assignment study to further assess the long-term safety and MS 12 months 1 site United States Enrollment complete, active study 13 sites United States Enrollment complete, results pending 4 sites Germany Currently enrolling 22 sites U.S. and Canada 20 sites Australia and U.S. Enrollment complete, active study Enrollment complete, active study N/A Not yet open for patient enrollment 3 sites Germany Currently enrolling tolerability of up to 30 grams of creatine daily in HD participants National Institute of Neurological Disorders and Stroke SITES 1 year (NIH) Teva Pharmaceutical Industries 6 hours the worsening of symptoms of HD 800-487-7671 Steven M Hersch, MD, PhD TRIAL LENGTH Randomized double blind study testing the tolerability of treatment with 600, 1200 or 2400 mg per day of coenzyme Q10 in preElaine M Julian-Baros, manifest participants carrying the CAGn BS: 585-273-2879 expansion for HD Christopher Ross, MD, PhD, Josef Priller, MD +49 (0)30 450 617209 Randomized double blind study testing the efficacy and tolerability of (2)epigallocatechin-3-gallate (EGCG) in changing cognitive function in patients with HD Karl Kieburtz, MD Open label, single group assignment study to assess the long-term safety of 45 mg of MPH 20 weeks 1 year 2 years pridopidine in HD participants Randomized, double-blind safety and 800-487-7671 (U.S.) tolerability study of PBT2 of individuals with mild to moderate HD 800-794-669 (Australia) Ray Dorsey, MD Prana Biotechnology PBT2 II Pfizer PF-0254920 II Pfizer CT.gov Call Center, 800-718-1021 Charite University Bupropion II Josef Priller, MD +49 (0)30 450 617209 Randomized double-blind study testing the efficacy and tolerability of PF-0254920 in changing the total motor score patients with HD Randomized double-blind study testing the efficacy and tolerability of Bupropion in changing Apathy in patients with HD 6 months 28 days 10 weeks Sources: www.clinicaltrials.gov and apps.who.int/trialsearch/ To update or add a clinical trial, please e-mail editor@hdinsights.org. 8 Copyright © Huntington Study Group 2013. All rights reserved. HD Insights, Vol. 5