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

Completed · Phase 2 · Has a placebo group

Conditions studied: Dyskinesias, Parkinson Disease, Movement Disorders, Parkinsonian Disorders, Anti-Dyskinesia Agents

In brief

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)

Key facts

Study ID

NCT01491529

Run by

Novartis Pharmaceuticals

People needed

154

Starts

2012-04-01

Expected to finish

2013-04-01

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…

• Males and Females 30-80 years old
• Use of highly effective methods of contraception during study in women of childbearing potential
• Outpatients
• Clinical diagnosis of Parkinson's Disease according to UK Parkinson's Disease Society Brain Bank Clinical Diagnosis criteria
• Score of >/= 2 on UPDRS items 32 and 33
• Dyskinesias for at least 3 months before baseline
• On stable treatment regimen with L-dopa and other anti-parkinsonian treatment for 4 weeks prior to baseline
• Demonstrate capacity to complete accurate diary ratings
• Patients who have a primary caregiver willing to assess the condition of the patient throughout the study in accordance with protocol requirements
• Group 2 only: 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

You may not qualify if…

• Atypical/secondary form of Parkinson's disease
• History of surgical treatment of PD, including deep brain stimulation
• A score of 5 in the "ON"- state on the Modified Hoehn and Yahr scale
• Advanced, severe, or unstable disease other than PD
• Evidence of dementia
• Treatment with certain prohibited medications
• Amantadine within 2 weeks prior to BL1 visit (applies to Group 1 only)
• Other protocol-defined inclusion/exclusion criteria may apply.

Where it is running

• Novartis Investigative Site — Sunnyvale, California, United States
• Novartis Investigative Site — Englewood, Colorado, United States
• Novartis Investigative Site — Tampa, Florida, United States
• Novartis Investigative Site — Kansas City, Kansas, United States
• Novartis Investigative Site — Milwaukee, Wisconsin, United States
• Novartis Investigative Site — Innsbruck, Austria
• Novartis Investigative Site — Linz, Austria
• Novartis Investigative Site — Vienna, Austria
• Novartis Investigative Site — London, Ontario, Canada
• Novartis Investigative Site — Clermont-Ferrand, France
• Novartis Investigative Site — Lille, France
• Novartis Investigative Site — Pessac, France
• Novartis Investigative Site — Poitiers, France
• Novartis Investigative Site — Beelitz-Heilstätten, Germany
• Novartis Investigative Site — Berlin, Germany
• Novartis Investigative Site — Bochum, Germany
• Novartis Investigative Site — Düsseldorf, Germany
• Novartis Investigative Site — Kassel, Germany
• Novartis Investigative Site — Leipzig, Germany
• Novartis Investigative Site — München, Germany
• Novartis Investigative Site — München, Germany
• Novartis Investigative Site — Stadtroda, Germany
• Novartis Investigative Site — Budapest, Hungary
• Novartis Investigative Site — Kaposvár, Hungary
• Novartis Investigative Site — Szeged, Hungary

Full record on ClinicalTrials.gov

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