Safety and Efficacy of AQW051 in L-dopa Induced Dyskinesias in Patients With Parkinson's Disease
NCT ID: NCT01474421
Last Updated: 2020-12-24
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
71 participants
INTERVENTIONAL
2011-09-15
2013-02-21
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
DOUBLE
Study Groups
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AQW051 High Dose
AQW051 high dose daily given orally for 28 days.
AQW051
Patients will receive AQW051 in a high dose once daily orally for 28 days.
AQW051 Low Dose
AQW051 low dose daily given orally for 28 days.
AQW051
Patients will receive AQW051 in a low dose once daily orally for 28 days.
Placebo
Placebo daily given orally for 28 days.
Placebo
Patients will receive placebo once daily orally for 28 days.
Interventions
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AQW051
Patients will receive AQW051 in a high dose once daily orally for 28 days.
AQW051
Patients will receive AQW051 in a low dose once daily orally for 28 days.
Placebo
Patients will receive placebo once daily orally for 28 days.
Eligibility Criteria
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Inclusion Criteria
* Patients with dyskinesias for at least 3 months
* Patients with moderate to severe dyskinesias
* Patients on L-dopa treatment for at least 3 years
Exclusion Criteria
* Patients who have had prior surgery for Parkinson's disease
* Patients who are cognitively impaired, have psychosis, have confusional states or hallucinate
* Patients who received neuroleptics or anti-psychotics within 2 months
* Women of child-bearing potential
30 Years
85 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
Sacramento, California, United States
Novartis Investigative Site
Manhasset, New York, United States
Novartis Investigative Site
Cincinnati, Ohio, United States
Novartis Investigative Site
Cleveland, Ohio, United States
Novartis Investigative Site
Bron, , France
Novartis Investigative Site
Clermont Fd, , France
Novartis Investigative Site
Lille, , France
Novartis Investigative Site
Marseille, , France
Novartis Investigative Site
Montpellier, , France
Novartis Investigative Site
Nantes, , France
Novartis Investigative Site
Paris, , France
Novartis Investigative Site
Pessac, , France
Novartis Investigative Site
Poitiers, , France
Novartis Investigative Site
Strasbourg, , France
Novartis Investigative Site
Toulouse, , France
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Dresden, , Germany
Novartis Investigative Site
Gera, , Germany
Novartis Investigative Site
Haag, , Germany
Novartis Investigative Site
Kassel, , Germany
Novartis Investigative Site
Marburg, , Germany
Novartis Investigative Site
München, , Germany
Novartis Investigative Site
Tübingen, , Germany
Novartis Investigative Site
Roma, RM, Italy
Countries
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References
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Trenkwalder C, Berg D, Rascol O, Eggert K, Ceballos-Baumann A, Corvol JC, Storch A, Zhang L, Azulay JP, Broussolle E, Defebvre L, Geny C, Gostkowski M, Stocchi F, Tranchant C, Derkinderen P, Durif F, Espay AJ, Feigin A, Houeto JL, Schwarz J, Di Paolo T, Feuerbach D, Hockey HU, Jaeger J, Jakab A, Johns D, Linazasoro G, Maruff P, Rozenberg I, Sovago J, Weiss M, Gomez-Mancilla B. A Placebo-Controlled Trial of AQW051 in Patients With Moderate to Severe Levodopa-Induced Dyskinesia. Mov Disord. 2016 Jul;31(7):1049-54. doi: 10.1002/mds.26569. Epub 2016 Mar 15.
Related Links
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Results for CAQW051A2209 from the Novartis Clinical Trials Website
Other Identifiers
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2011-001092-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CAQW051A2209
Identifier Type: -
Identifier Source: org_study_id