Issue link: http://www.e-digitaleditions.com/i/264493
Copyright © Huntington Study Group 2014. All rights reserved. Clinical Trials Status Report SPONSOR STUDY AGENT PHASE PRINCIPAL INVESTIGATOR, CONTACT DESIGN TRIAL LENGTH SITES STATUS New York Medical College Tetrabenazine IV 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 6 hours 1 site - Terence Cardinal Cooke Health Care Center Currently enrolling National Institute of Neurological Disorders and Stroke Coenzyme Q10 III Merit Cudkowicz, MD, MSc Huntington Study Group: 800-487-7671 Randomized double-blind study to see whether coenzyme Q10 is effective in slowing the worsening of symptoms of HD 5 years 49 sites - U.S., Canada, Australia Enrollment complete, active study Auspex Pharmaceuticals, Inc. SD-809 Extended Release III Samuel Frank, MD Huntington Study Group: 800-487-7671 Randomized double blind study to determine whether SD-809 ER tablets are effective in the treatment of chorea associated with HD 12 weeks 7 sites - U.S. Currently enrolling Auspex Pharmaceuticals, Inc. SD-809 Extended Release III Samuel Frank, MD Huntington Study Group: 800-487-7671 Open-label, long term safety study of SD-809 ER 58 weeks 7 sites - U.S. Currently enrolling National Center for Complementary and Alternative Medicine Creatine III Steven M Hersch, MD, PhD Huntington Study Group: 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 3 years 52 sites - U.S., Canada, Australia, New Zealand Currently enrolling Assistance Publique - Hôpitaux de Paris Olanzapine, Tetrabenazine and Tiapride III Anne-Catherine Bachoud Levi, PhD +33 (0)1 49 81 23 01 Randomized controlled study to compare the beneficial and adverse effects of 3 different neuroleptics in HD 1 year 1 site - Europe Currently enrolling Raptor Pharmaceuticals Cysteamine Bitartrate Delayed-release Capsules (RP103) II/III Christophe Verny, MD Double-blind, placebo-controlled study to be followed by an open-label extension study 18 months 8 total - France Study complete, results pending National Institute of Neurological Disorders and Stroke Coenzyme Q10 II Christopher Ross, MD, PhD, Elaine M Julian- Baros, BS: 585-273-2879 Randomized double blind study testing the tolerability of treatment with 600, 1200 or 2400 mg per day of coenzyme Q manifest participants carrying the CAGn expansion for HD 20 weeks 13 sites - United States Study complete, top line results released Charité University Epigallo- catechin Gallate II 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 1 year 4 sites - Germany Currently enrolling Teva Pharmaceutical Industries Pridopidine II Karl Kieburtz, MD MPH Open label, single group assignment study to assess the long-term safety of 45 mg of pridopidine in HD participants 2 years 22 sites - U.S. and Canada Enrollment complete, study ongoing Prana Biotechnology PBT2 II Ray Dorsey, MD 800-487-7671 (U.S.) 800-794-669 (Australia) Randomized, double-blind safety and tolerability study of PBT2 of individuals with mild to moderate HD 6 months 20 sites - Australia and U.S. Study complete, results pending Pfizer PF-0254920 II Pfizer CT.gov Call Center, 800-718-1021 Randomized double-blind study testing the efficacy and tolerability of PF-0254920 in changing the total motor score patients with HD 28 days Paris, France Currently enrolling Charité University Bupropion II Josef Priller, MD +49 (0)30 450 617209 Randomized double-blind study testing the efficacy and tolerability of Bupropion in changing apathy in patients with HD 10 weeks 3 sites - Germany Currently enrolling Sources: www.clinicaltrials.gov and apps.who.int/trialsearch/ To update or add a clinical trial, please e-mail editor@hdinsights.org. H D I N S I G H T S HD Insights, Vol. 7 9

