NCT01092065

Efficacy and Safety of AFQ056 When Combined With Increased Doses of L-dopa in Parkinson's Disease Patients With Moderate-severe L-dopa Induced Dyskinesia

A 6-week, Double-blind, Placebo-controlled, Randomized, Multicenter Study to Explore the Efficacy and Safety of AFQ056 When Combined With Increased Doses of L-dopa in Parkinson's Disease Patients With OFF Time and Moderate-severe L-dopa Induced Dyskinesia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This Phase IIb exploratory study is designed to determine whether AFQ056 is safe and effective and whether it can increase the therapeutic window of L-dopa in patients whose control of their Parkinson's Disease symptoms is limited by the development of dyskinesia induced by use of L-dopa.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	AFQ056 with L-dopa	hard gelatin capsule to be taken bid for six weeks
DRUG	Placebo	hard gelatin capsule to be taken bid for six weeks

Timeline

• Start date: 2010-03-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2010-03-24
• Last updated: 2020-12-23

Locations

4 sites across 1 country: United States