NCT02439125

A Study of Efficacy and Safety of Eltoprazine HCl for Treating Levodopa-induced Dyskinesia in Parkinson's Disease Patients

Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, 4-way Crossover, Dose-finding Study, of Eltoprazine Safety, Tolerability and Efficacy in the Treatment of Levodopa-induced Dyskinesia in Patients With Parkinson's Disease

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Amarantus BioScience Holdings, Inc. · Industry
• Sex: All
• Age: 30 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, tolerability and efficacy of eltoprazine to treat levodopa-induced dyskinesia in patients with Parkinson's disease

Detailed description

A double-blind, placebo-controlled, crossover, dose-range finding study in patients with Parkinson's disease and levodopa-induced dyskinesia. The study will examine the effects of three different doses of eltoprazine HCl, compared to placebo, on severity of dyskinesia, parkinsonian symptoms, patient function, safety and tolerability, using Parkinson's disease rating scales, patient diaries and physiological measurement of abnormal movement by means of motion sensors.

Conditions

• Parkinson's Disease
• Dyskinesia

Interventions

Type	Name	Description
DRUG	Eltoprazine HCl	2.5 mg b.i.d. orally for 3 weeks
DRUG	Eltoprazine HCl	5.0 mg b.i.d. orally for 3 weeks
DRUG	Eltoprazine HCl	7.5 mg b.i.d. orally for 3 weeks
DRUG	Placebo	b.i.d. orally for 3 weeks

Timeline

• Start date: 2015-05-01
• Primary completion: 2017-06-01
• Completion: 2017-12-01
• First posted: 2015-05-08
• Last updated: 2016-04-22

Locations

1 site across 1 country: United States