HD Insights™

Vol. 10 v.9 FINAL

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H D I N S I G H T S HD Insights, Vol. 10 9 Copyright © Huntington Study Group 2015. All rights reserved. Clinical Trials Update SPONSOR STUDY NAME/ IDENTIFIER STUDY AGENT PHASE PRINCIPAL INVESTIGATOR, CONTACT DESIGN TRIAL LENGTH SITES STATUS Charité University ETON-Study Epigallocatechin 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 HD patients 1 year 4 total - Germany Enrollment complete, study ongoing Charité University Action-HD 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 total - Germany Study complete Ipsen NCT02231580 BN82451B II Bruno Padrazzi, M.D. clinical.trials@ipsen. com Dose escalation, proof of concept study to investigate the safety and tolerability, the pharmacokinetic and the pharmacodynamic properties of twice daily BN82451B for four weeks in male patients with HD 28 days 1 total - Germany Currently enrolling Omeros Corporation NCT02074410 OMS643762 II Albert Yu, MD 206-676-5000 Randomized, double-blind, placebo-controlled, sequential cohort study to evaluate safety and efficacy of OMS643762 in subjects with HD 28 days 4 total - United States Trial suspended Prana Biotechnology REACH2HD PBT2 II Ray Dorsey, MD Randomized double-blind safety and tolerability study of PBT2 of individuals with mild to moderate HD 6 months 20 total - Australia and United States Results published Pfizer NCT01806896 PF-0254920 II Pfizer CT.gov Call Center, 800-718-1021 Randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and brain cortico-striatal function of 2 doses of PF-02545920 in individuals with early HD 28 days Paris, France Currently enrolling Pfizer NCT02197130 PF-0254920 II Pfizer CT.gov Call Center, 800-718-1021 Randomized, double-blind, placebo-controlled proof of concept study of the efficacy and safety of PF-02545920 in HD 26 weeks 23 total - Europe and United States Currently enrolling Teva Pharmaceutical Industries PRIDE-HD Pridopidine II Teva US Medical Information 800-896-5855 Randomized, double-blind, placebo-controlled study of safety and efficacy of pridopidine 45 mg, 67.5 mg, 90 mg, and 112.5 mg BID versus placebo for symptomatic treatment in patients with HD 26 weeks 57 total - worldwide Currently enrolling Teva Pharmaceutical Industries OPEN-HART 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 total - United States and Canada Enrollment complete, study ongoing Teva Pharmaceutical Industries LEGATO-HD Laquinimod II Teva US Medical Information 800-896-5855 Randomized, double-blind, placebo-controlled, parallel-group study evaluating efficacy and safety of Laquinimod (0.5, 1.0 and 1.5 mg/day) in HD 12 months 46 total - worldwide Currently enrolling Raptor Pharmaceuticals CYST-HD 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 36 months 8 total - France Study ongoing, preliminary results released National Institute of Neurological Disorders and Stroke 2CARE Coenzyme Q10 III Merit Cudkowicz, MD, MSc Randomized double-blind study to see whether coenzyme Q10 is effective in slowing the worsening of symptoms of HD 5 years 48 total - United States, Canada, Australia Study concluded for futility National Center for Complementary and Alternative Medicine CREST-E Creatine III Steven M Hersch, MD, PhD Randomized double-blind study to test whether high-dose creatine can slow the progressive functional decline that occurs in adults with early clinical features of HD 3 years 52 total - United States, Canada, Australia, New Zealand Study concluded for futility To update or add a clinical trial, please e-mail editor@hdinsights.org. Sources: www.clinicaltrials.gov and apps.who.int/trialsearch/ H D I N S I G H T S

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