Open PRIdopidine Dose Evaluation in Huntington's Disease
Research type
Research Study
Full title
A Multi-Center, Open-Label Study Evaluating the Safety, Tolerability, and Efficacy of Pridopidine in Patients with Huntington’s Disease (Open PRIDE-HD)
IRAS ID
182663
Contact name
Spyridon Papapetropoulos
Contact email
Sponsor organisation
Teva Branded Pharmaceutical Products R&D, Inc
Eudract number
2015-000904-24
Duration of Study in the UK
1 years, 8 months, 1 days
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 (TV7820) 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 open-label, multi center study is to evaluate safety and tolerability of pridopidine 45 mg twice daily (bid)in patients with HD.
Secondary Objectives: The secondary objectives of the study are to assess the effects of long-term, open-label dosing with pridopidine on motor symptom severity, overall patient function, physical performance, and health-related quality of life in patients with HD.
Approximately 400 patients from approximately 54 investigational centres in multiple countries are planned to be enrolled in the study. Patients will be treated with study drug for 52 weeks. After the 1 week titration period, patients will be seen at Weeks 4, 12, 26 and 52. An End of Study (EoS) visit will take place at Week 54. Patients who withdraw from the study will have the early termination procedures and assessments performed at their final visit.REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
15/EM/0393
Date of REC Opinion
13 Nov 2015
REC opinion
Further Information Favourable Opinion