5 HD Insights, Vol. 12
Copyright © Huntington Study Group 2015. All rights reserved.
Clinical Trials Status Report
H D I N S I G H T S
SPONSOR STUDY
NAME/
IDENTIFIER
STUDY
AGENT
PHASE PRINCIPAL
INVESTIGATOR,
CONTACT
DESIGN TRIAL
LENGTH
SITES STATUS
Azevan
Pharmaceuticals
NCT02507284 SRX246
I/II
None provided
Randomized, placebo-controlled, double-blind,
12 week, 3-arm dose escalation study of SRX246
in individuals with irritability and early
symptomatic HD
12 weeks None listed
Not yet
enrolling
Isis
Pharmceuticals
NCT02519036 ISIS-HTTRx
I/II
Isis Pharmaceuticals
800-679-4747
patients@isisph.com
Randomized, double-blind, placebo-controlled
study to to assess the safety, tolerability,
pharmacokinetics and pharmacodynamics of
multiple ascending doses of intrathecally
administered ISIS 443139 in patients with early
manifest HD
29 weeks
6 total -
Canada,
Germany,
and the UK
Currently
enrolling
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
Study
complete
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
Heinrich-Heine
University
HD-DBS
ACTIVA® PC
neuro-
stimulator
(Model 37601)
II
Susanne Harnisch
+49 6421 2866553
susanne.harnisch@k
ks.uni-marburg.de
Randomized, double-blind, parallel-group,
sham-controlled, multi-centre trial of Globus
Pallidus Deep Brain Stimulation in individuals
with HD
3 months
6 total -
Germany
Currently
enrolling
Institut National
de la Santé et de la
Recherche
Médicale
TRIHEP3 Triheptanoin oil
II
Alexandra Durr
+331 57 27 46 82
alexandra.durr@up
mc.fr
Randomized, double-blind, controlled study of
Triheptanoin oil, an anapldrotic therapy, in early
manifest HD
12 months
3 total -
France and
the
Netherlands
Not yet
enrolling
Ipsen NCT02231580 BN82451B
II
Bruno Padrazzi, MD
clinical.trials@ipsen.
com
Dose escalation, proof-of-concept study to
investigate the safety and tolerability and 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
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
Study
complete
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
Katie Blatt,
Teva
610-727-3297
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
Sarah Boe,
Teva
610-727-3486
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
Vaccinex Inc. SIGNAL VX15/2503
II
Andrew Feigin, MD,
Huntington Study
Group: 800-487-7671
Randomized, double-blind, placebo-controlled
study to assess the safety, tolerability,
pharmacokinetics, and efficacy of VX15/2503 in
individuals with late prodromal and early
manifest HD
12-22 months
2 total -
United Staes
Currently
enrolling
To update or add a clinical trial, please e-mail editor@hdinsights.org.
Sources: www.clinicaltrials.gov and apps.who.int/trialsearch/
