NCT01474421

Safety and Efficacy of AQW051 in L-dopa Induced Dyskinesias in Patients With Parkinson's Disease

A Multi-centre, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multiple Oral Dose Study to Assess the Efficacy, Safety and Tolerability of AQW051 in Reducing L-dopa Induced Dyskinesias in Parkinson's Patients With Moderate to Severe L-dopa Induced Dyskinesias

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 30 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the safety, tolerability and efficacy of AQW051 in treating moderate to severe L-dopa induced dyskinesias (movement disorders) in patients with Parkinson's disease.

Conditions

• Dyskinesias
• Drug-induced

Interventions

Type	Name	Description
DRUG	AQW051	Patients will receive AQW051 in a high dose once daily orally for 28 days.
DRUG	AQW051	Patients will receive AQW051 in a low dose once daily orally for 28 days.
DRUG	Placebo	Patients will receive placebo once daily orally for 28 days.

Timeline

• Start date: 2011-09-15
• Primary completion: 2013-02-21
• Completion: 2013-02-21
• First posted: 2011-11-18
• Last updated: 2020-12-24

Locations

24 sites across 4 countries: United States, France, Germany, Italy

Regulatory

• FDA-regulated drug study