Study of Pridopidine to reduce symptoms in patients with Huntington’s
Research type
Research Study
Full title
A Phase 2, Dose-Finding, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Study, Evaluating the Safety and Efficacy of Pridopidine 45 mg, 67.5 mg, 90 mg, and 112.5 mg Twice-Daily versus Placebo for Symptomatic Treatment in Patients with Huntington’s Disease
IRAS ID
135977
Contact name
David Craufurd
Contact email
Sponsor organisation
Teva Branded Pharmaceutical Products R&D, Inc
Eudract number
2013-001888-23
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
N/A
Research summary
Huntington’s disease (HD) is an inherited disorder which causes a wide range of symptoms affecting the central nervous system. Currently, there is no available treatment to stop or reverse the disease.
The disease is caused by a mutated gene which leads to production of a faulty protein, mutant huntingtin. The disease is characterised by a group of motor, behavioural, and cognitive symptoms. Motor disturbances are the defining feature of the disease, with chorea (involuntary movements) the most evident motor symptom.
There is considerable evidence that the neurotransmitter dopamine (a chemical released by nerve cells to send signals to other nerve cells within the brain, responsible for various aspects of brain function including motor functions) is compromised in patients with Huntington’s disease. Pridopidine (TV-7820) is a drug under development from a new class of drugs which are considered to have dopaminergic stabilizing properties. The primary effect of pridopidine on HD-related motor symptoms is therefore expected to occur through the dopamine transmissions.
The primary objective of this study is to assess the efficacy and dose-response of pridopidine 67.5 to 112.5 mg twice daily on motor impairment in patients with HD after 26 weeks of treatment using the Unified Huntington’s Disease Rating Scale - Total Motor Score.
Approximately 400 patients from approximately 40 investigational centres in multiple countries are planned to be enrolled in the study. There are 5 treatment arms (pridopidine 45, 67.5, 90, and 112.5 mg twice daily or placebo) which will each contain 80 patients. The 45 mg dose level will not be formally included in the efficacy analyses.
For each patient, the duration of participation is planned to be 30 weeks, consisting of a 2week screening period, a 26-week randomized double-blind treatment period (comprised of a 4-week titration and 22-week full dose period), and a 2-week safety follow-up period following the last dose of study medication.REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
13/EM/0424
Date of REC Opinion
10 Jan 2014
REC opinion
Further Information Favourable Opinion