Copyright © Huntington Study Group 2014. All rights reserved.
Clinical Trials Status Report
SPONSOR STUDY
NAME/
IDENTIFIER
STUDY
AGENT
PHASE
PRINCIPAL
INVESTIGATOR,
CONTACT
DESIGN TRIAL
LENGTH
SITES STATUS
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 sites - U.S. 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
U.S. 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 sites -
U.S. and
Canada
Enrollment
complete, study
ongoing
Prana
Biotechnology
REACH2HD
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,
top line results
released
Pfizer
NCT01806896
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
ETON-Study
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
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 sites -
Germany
Enrollment
complete, study
ongoing
Raptor
Pharmaceuticals
CYST-HD
Cysteamine
Bitartrate
Delayed
release
(RP103)
II/III
Christophe Verny,
MD
Double-blind, placebo-controlled study to be
followed by an open-label extension study
18 months
8 sites -
France
Study ongoing,
preliminary
results released
National Institute
of Neurological
Disorders and
Stroke
2CARE
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
Study concluded
for futility
(see p.1)
Auspex
Pharmaceuticals,
Inc.
FIRST-HD
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. Enrollment
complete, study
ongoing
Auspex
Pharmaceuticals,
Inc.
ARC-HD
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
Assistance
Publique -
Hôpitaux de
Paris
NEUROHD
Olanzapine,
Tetrabenazin
e 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
National Center
for
Complementary
and Alternative
Medicine
CREST-E
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
New York Medical
College
NCT1834911
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
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. 8 8
