Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias
NCT ID: NCT01491529
Last Updated: 2020-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
154 participants
INTERVENTIONAL
2012-04-30
2013-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AFQ056 150 mg
Patients randomized to the AFQ056 150 mg arm will receive AFQ056 oral tablets to be titrated until reaching the target dose of 150 mg twice daily.
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.)
AFQ056 200 mg
Patients randomized to the AFQ056 200 mg arm will receive AFQ056 oral tablets to be titrated until reaching the target dose of 200 mg twice daily.
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.)
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.)
Placebo
Patients randomized to the Placebo arm will receive oral AFQ056 Placebo twice daily
Placebo
Placebo for AFQ056 will be supplied as oral tablets.
Interventions
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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.)
Placebo
Placebo for AFQ056 will be supplied as oral tablets.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
30 Years
80 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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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
Novartis Investigative Site
Brescia, BS, Italy
Novartis Investigative Site
Bolzano, BZ, Italy
Novartis Investigative Site
Pisa, PI, Italy
Novartis Investigative Site
Roma, RM, Italy
Novartis Investigative Site
Roma, RM, Italy
Novartis Investigative Site
Bratislava, , Slovakia
Novartis Investigative Site
Bratislava, , Slovakia
Novartis Investigative Site
Donostia / San Sebastian, Basque Country, Spain
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Sant Cugat del Vallès, Catalonia, Spain
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Bern, , Switzerland
Novartis Investigative Site
Lausanne, , Switzerland
Countries
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References
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Trenkwalder C, Stocchi F, Poewe W, Dronamraju N, Kenney C, Shah A, von Raison F, Graf A. Mavoglurant in Parkinson's patients with l-Dopa-induced dyskinesias: Two randomized phase 2 studies. Mov Disord. 2016 Jul;31(7):1054-8. doi: 10.1002/mds.26585. Epub 2016 May 23.
Related Links
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Results for CAFQ056A2223 from the Novartis Clinical Trials Website
Other Identifiers
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2011-002074-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CAFQ056A2223
Identifier Type: -
Identifier Source: org_study_id