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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 DESIGN Lundbeck LLC 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 Christophe Verny, M.D. Double-blind, placebo-controlled study to be followed by an open-label extension study National Institutes of Health Creatine II Diana Rosas, MD, MS Open label, single group assignment study to further assess the long-term safety and tolerability of up to 30 grams of creatine daily in HD participants National Institute of Neurological Disorders and Stroke Coenzyme Q10 II Christopher Ross, Randomized double blind study testing the tolerability of treatment with 600, 1200 or 2400 MD, PhD, Charite University Epigallocatechin Gallate II Neurosearch A/S Pridopidine II PRINCIPAL INVESTIGATOR, CONTACT Sandra K Kostyk, MD, Prospective case control study to compare PhD spatial and temporal gait measures, 614-688-8672 performance on functional mobility measures, and amount of daily walking activity before and after administration of tetrabenazine in individuals with HD. Randomized double blind study to see if Merit Cudkowicz, coenzyme Q10 is effective in slowing the MD, MSc worsening of symptoms of HD 800-487-7671, TRIAL LENGTH SITES STATUS 1 site Ohio State University Medical Center Currently enrolling 49 sites U.S., Canada, Australia Enrollment complete, active study N/A Not yet open for patient enrollment 51 sites U.S., Canada, Australia, New Zealand Currently enrolling 1 year 1 site Europe Currently enrolling 18 months 8 total France Enrollment complete, results pending 1 site United States Enrollment complete, active study 13 sites United States Enrollment complete, results pending 4 sites Germany Currently enrolling 25 sites U.S. and Canada Enrolling by invitation only 20 sites Australia and U.S. Enrollment complete, active study 7 sites United States Enrollment complete, results pending 3 years 5 years www.huntington-studygroup.org Samuel Frank, MD Randomized double blind study to determine whether SD-809 ER tablets are effective in the treatment of chorea associated with HD Steven M Hersch, MD, PhD Randomized double blind study to test whether high-dose creatine can slow the 800-487-7671, progressive functional decline that occurs in www.huntington-studyadult persons with early clinical features of group.org HD Randomized controlled study to compare the Anne-Catherine Bachoud Levi, PhD beneficial and adverse effects of 3 different neuroleptics in HD +33 (0)1 49 81 23 01 Elaine M Julian-Baros, mg per day of coenzyme Q10 in pre-manifest participants carrying the CAGn expansion for BS: 585-273-2879 HD Randomized double blind study testing the Josef Priller, MD efficacy and tolerability of (2)+49 30 450 617209 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 2 years 3 years 12 months 20 weeks 1 year 2 years pridopidine in HD participants Prana Biotechnology PBT2 II Siena Biotech Selisistat, SEN0014196 I Randomized, double-blind safety and Ray Dorsey, MD tolerability study of PBT2 of individuals with 800-487-7671 (U.S.) mild to moderate HD 800-794-669 (Australia) Francis Walker, MD, Goran Westerberg,PhD: gwesterberg@ sienabiotech.it Open-label, randomized, parallel group design at one dose level of SEN0014196 in patients with early stage HD 6 months 14 days Sources: www.clinicaltrials.gov and apps.who.int/trialsearch/ To update or add a clinical trial, please e-mail editor@hdinsights.org. 6 Copyright © Huntington Study Group 2013. All rights reserved. HD Insights, Vol. 4