NCT01491529

Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias

13-week, Double-blind, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of Modified Release AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 154 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the efficacy and safety of modified release AFQ056 in patients that have Parkinson's Disease L-dopa Induced Dyskinesias (PD-LID)

Conditions

• Dyskinesias
• Parkinson Disease
• Movement Disorders
• Parkinsonian Disorders
• Anti-Dyskinesia Agents

Interventions

Type	Name	Description
DRUG	AFQ056	AFQ056 will be supplied as oral modified release tablets in 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg. Patients will be randomized in two groups by amantadine status. * Group 1: Patients are not permitted to take amantadine within 2 weeks prior to the BL1 visit. * Group 2: Patients must be on a stable and well tolerated dose of amantadine for at least 4 weeks prior to BL1 and must maintain the stable dose of amantadine during the remainder of the study.)
DRUG	Placebo	Placebo for AFQ056 will be supplied as oral tablets.

Timeline

• Start date: 2012-04-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2011-12-14
• Last updated: 2020-12-23

Locations

39 sites across 10 countries: United States, Austria, Canada, France, Germany, Hungary, Italy, Slovakia, Spain, Switzerland