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

Completed · Phase 2 · Has a placebo group

Conditions studied: Parkinson's Disease

In brief

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.

Key facts

Study ID

NCT01092065

Run by

Novartis

People needed

23

Starts

2010-03-01

Expected to finish

2011-07-01

Last updated by the study team

2020-12-23

Who can join

Age: 30 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Outpatients with Parkinson's Disease (PD), treated with L-dopa, experiencing OFF time and dyskinesias for at least three months

You may not qualify if…

• Surgical treatment for PD
• Cancer within the past 5 years (other than localized skin cancer and prostate cancer that has been effectively treated)
• Advanced, severe or unstable disease (other than PD) that may interfere with the study outcome evaluations
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• The Parkinsons Institute — Sunnyvale, California, United States
• Colorado Neurological Institute — Englewood, Colorado, United States
• Indiana University School of Medicine — Indianapolis, Indiana, United States
• University of Kansas Medical Center - Parkinson's Disease and Movement Disorders Center — Kansas City, Kansas, United States

Full record on ClinicalTrials.gov

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