HD INSIGHTS Clinical Trials Status Report SPONSOR
Assistance Publique - Hôpitaux de Paris
National Institute of Neurological
Disorders and Stroke
National Center for Complementary and Alternative Medicine
National Institutes of Health
Creatine III
STUDY AGENT
Olanzapine,
Tetrabenazine and Tiapride
Coenzyme Q10
III PHASE III PRINCIPAL
INVESTIGATOR, CONTACT
Anne-Catherine
Bachoud Levi, PhD +33 (0)1 49 81 23 01
Merit Cudkowicz, MD, MSc 800-487-7671,
www.huntington-study- group.org
Steven M Hersch,
MD, PhD 800-487-7671,
www.huntington-study- group.org
Creatine III
Randomized controlled study to compare the beneficial and adverse effects of 3 different neuroleptics in Huntington disease
Randomized double blind study to see if coenzyme Q10 is effective in slowing the worsening of symptoms of Huntington disease
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 Huntington disease
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
National Institute of Neurological
Disorders and Stroke
National Institute of Neurological
Disorders and Stroke
Neurosearch A/S Pridopidine II
Coenzyme Q10
II Citalopram II Leigh Beglinger, PhD,
Blair Harrison, MPH: 319-353-4411
Christopher Ross, MD, PhD,
Elaine M Julian-Baros, BS: 585-273-2879
Karl Kieburtz, MD MPH
Charite University
Epigallo- catechin Gallate
Siena Biotech Selisistat, SEN0014196 Prana Biotechnology PBT2 II II
Josef Priller, MD +49 30 450 617209
II
Ralf Reilmann, MD +41 61 324 1111
Ray Dorsey, MD, Karen Helles: 800-487-7671 (U.S.) 800-794-669 (Australia)
www.huntington-study- group.org
Charite -
Universitätsmedizin Berlin
Siena Biotech Selisistat, SEN0014196 I Bupropion II
Josef Priller, MD +49 30 450 617209
Landwehrmeyer, MD, Bernhard
Goran Westerberg,PhD: gwesterberg@ sienabiotech.it
Siena Biotech Selisistat, SEN0014196 I
Francis Walker, MD, Goran Westerberg,PhD: gwesterberg@ sienabiotech.it
HD Insights, Vol. 2
Randomized, double blind, placebo-controlled prospective crossover trial investigating the efficacy and safety of the treatment with Bupropion in patients with apathy in Huntington disease
Randomized, double blind, placebo controlled parallel group design at two dose levels of
SEN0014196 in early-stage Huntington disease patients
Open-label, randomized, parallel group
design at one dose level of SEN0014196 in early stage Huntington disease patients
Sources: www.clinicaltrials.gov and apps.who.int/trialsearch/ Copyright © Huntington Study Group 2012. All rights reserved.
14 days
6 total - United States
22 weeks 4 total - Germany 14 days
6 total - Europe
Enrollment
complete, results expected 4Q 2012
Currently
enrolling, results expected 4Q 2012
On hold
Randomized double blind study of the effect of citalopram on tolerability, functional
measures, motor performance, and psychiatric status
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 Huntington disease
Open label, single group assignment study to assess the long-term safety of 45 mg of pridopidine in HD participants
Randomized double blind study testing the efficacy and tolerability of (2)-
epigallocatechin-3-gallate (EGCG) in changing cognitive function in patients with Huntington disease
Randomized, double blind, placebo-controlled parallel-group design at two dose levels of
SEN0014196 in early-stage Huntington disease patients
Randomized, double-blind safety and
tolerability study of PBT2 in individuals with early to mid-stage HD
6 months
17 total - U.S. and Australia
3 months
18 total - Europe
Currently
enrolling, results expected 4Q 2012
Enrollment
expected to begin early 2012
20 weeks 16 weeks 12 months DESIGN TRIAL LENGTH 1 year
1 total - Europe
5 years
47 total - U.S., Canada, Australia
3 years 45 total -
U.S., Canada, Australia,
New Zealand
1 total - United States
3 total - United States
13 total - United States
2 years
22 total - U.S. and Canada
1 year
3 total - Europe
Ongoing,
recruitment complete
Study complete, results expected 4Q 2012
Enrollment
complete, results expected 4Q 2012
Ongoing,
enrollment complete
Currently enrolling
Currently enrolling
Currently enrolling
SITES STATUS
Currently enrolling
5
