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HD INSIGHTS Clinical Trials Status Report SPONSOR STUDY AGENT National Institute of Neurological Disorders and Stroke National Institutes of Health National Center for Complementary and Alternative Medicine Assistance Publique - Hôpitaux de Paris Creatine Creatine III III Coenzyme Q10 PHASE III PRINCIPAL INVESTIGATOR, CONTACT Merit Cudkowicz, MD, MSc 800-487-7671, www.huntington-study- group.org 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 Steven M Hersch, MD, PhD 800-487-7671, www.huntington-study- group.org Olanzapine, Tetrabenazin eand Tiapride National Institute of Neurological Disorders and Stroke National Institute of Neurological Disorders and Stroke Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal Neurosearch A/S delta-9- tetrahydrocanna binol (THC) and cannabidiol (CBD) Pridopidine Siena Biotech Selisistat, SEN0014196 Charite University Epigallo- catechin Gallate Prana Biotechnology PBT2 II Citalopram II Coenzyme Q10 II Christopher Ross, MD, PhD, Elaine M Julian-Baros, BS: 585-273-2879 Leigh J. Beglinger, PhD Blair Harrison, MPH: 319-353-4411 Justo Garcia de Yébenes, MD +34 91 336 8833 II II II Karl Kieburtz, MD MPH Ralf Reilmann, MD +41 61 324 1111 Josef Priller, MD +49 30 450 617209 II Ray Dorsey, MD 800-487-7671 (U.S.) 800-794-669 (Australia) Charite - Universitätsmedizin Berlin Siena Biotech Selisistat, SEN0014196 I Bupropion II Josef Priller, MD +49 30 450 617209 Francis Walker, MD, Goran Westerberg,PhD: gwesterberg@ sienabiotech.it Open label, single group assignment study to assess the long-term safety of 45 mg of pridopidine in HD participants Randomized, double blind, placebo-controlled parallel-group design at two dose levels of SEN0014196 in early-stage HD patients Randomized double blind study testing the efficacy and tolerability of (2)- epigallocatechin-3-gallate (EGCG) in changing cognitive function in patients with HD Randomized, double-blind safety and tolerability study of PBT2 of individuals with mild to moderate HD Randomized, double blind, placebo-controlled prospective crossover trial investigating the efficacy and safety of the treatment with Bupropion in patients with apathy in HD Open-label, randomized, parallel group design at one dose level of SEN0014196 in patients with early stage HD Sources: www.clinicaltrials.gov and apps.who.int/trialsearch/ To update or add a clinical trial, please e-mail editor@hdinsights.org. HD Insights, Vol. 3 Copyright © Huntington Study Group 2012. All rights reserved. 5 6 months 20 sites - U.S. and Australia 22 weeks 14 days 4 sites - Germany 7 sites - United States Currently enrolling On hold Currently enrolling, results expected 4Q 2012 2 years 3 months 1 year 25 sites - U.S. and Canada 18 sites - Europe 4 sites - Germany Enrollment complete, study ongoing Currently enrolling, results expected 4Q 2012 Currently enrolling Randomized double blind study testing the tolerability of treatment with 600, 1200 or 2400 mg per day of coenzyme Q10 in pre-manifest participants carrying the CAGn expansion for HD Randomized double blind study of the effect of Citalopram on tolerability, functional measures, motor performance, and psychiatric status A double-blind, randomized, cross over, placebo-controlled Phase 2 clinical trial to assess neuroprotection by cannabinoids in HD 9 months 20 weeks 13 sites - United States 16 weeks 3 sites - United States 1 site - Spain Enrollment complete, results expected 4Q 2012 Enrollment complete, study ongoing Enrollment complete, study ongoing III Anne-Catherine Bachoud Levi, PhD +33 (0)1 49 81 23 01 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 Randomized controlled study to compare the beneficial and adverse effects of 3 different neuroleptics in HD 1 year 3 years 12 months Randomized double blind study to see if coenzyme Q10 is effective in slowing the worsening of symptoms of HD DESIGN TRIAL LENGTH 5 years SITES STATUS 47 sites - U.S., Canada, Australia 1 site - United States 60 sites - U.S., Canada, Australia, New Zealand 1 site - Europe Enrollment complete, study ongoing Enrollment complete, study ongoing Currently enrolling Currently enrolling