Open-label, Long-term Safety Extension Study of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias

Completed · Phase 2

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

In brief

This study is to evaluate long-term safety, tolerability and efficacy for AFQ056 in patients who have completed an AFQ056A study in Parkinson's disease L-dopa induced dyskinesias (PD-LID).

Key facts

Study ID

NCT01491932

Run by

Novartis Pharmaceuticals

People needed

129

Starts

2012-03-01

Expected to finish

2013-10-01

Last updated by the study team

2020-12-23

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients who have completed a previous AFQ056A study or are eligible as defined in the core study protocol
• Outpatients
• Patients who have a primary caregiver willing and able to assess the condition of the patient throughout the study in accordance with protocol requirements

You may not qualify if…

• Atypical or secondary form of Parkinson's disease
• History of surgical treatment for PD including deep brain stimulation
• Advanced, severe, or unstable disease (other than PD)
• History of malignancy
• Evidence of dementia
• Untreated/ineffectively treated mental disorders
• Treatment with certain prohibited medications
• Abnormal lab values or heart abnormalities
• Pregnant or nursing women

Where it is running

• Novartis Investigative Site — Englewood, Colorado, 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 — Beelitz-Heilstätten, Germany
• Novartis Investigative Site — Berlin, Germany
• Novartis Investigative Site — Bochum, Germany
• Novartis Investigative Site — Kassel, Germany
• Novartis Investigative Site — Leipzig, Germany
• Novartis Investigative Site — München, Germany
• Novartis Investigative Site — Stadtroda, Germany
• Novartis Investigative Site — Westerstede/Oldenburg, Germany
• Novartis Investigative Site — Kaposvár, Hungary
• Novartis Investigative Site — Szeged, Hungary
• Novartis Investigative Site — Brescia, BS, Italy
• Novartis Investigative Site — Pisa, PI, Italy
• Novartis Investigative Site — Roma, RM, Italy
• Novartis Investigative Site — Roma, RM, Italy
• Novartis Investigative Site — Bratislava, Slovakia

Full record on ClinicalTrials.gov

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