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

NCT ID: NCT01385592

Last Updated: 2020-12-23

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-09-30

Brief Summary

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This study will assess the efficacy and safety of AFQ056 in patients that have Parkinson's Disease L-dopa Induced Dyskinesias (PD-LID)

Detailed Description

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Conditions

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Dyskinesias Parkinson Disease Movement Disorders Parkinsonian Disorders

Keywords

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Parkinson Disease L-dopa Levodopa Dyskinesia Anti-Dyskinesia Agents

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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AFQ056 100 mg

Group Type EXPERIMENTAL

AFQ056

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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AFQ056

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Outpatients with Parkinson's disease (PD), treated with L-Dopa, experiencing dyskinesias for at least three months
* Outpatients who are on a stable anti-parkinsonian treatment regimen for at least four weeks

Exclusion Criteria

* 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) or evidence of dementia that may interfere with the study outcome evaluations
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Novartis Investigative Site

Englewood, Colorado, United States

Site Status

Novartis Investigative Site

London, Ontario, Canada

Site Status

Novartis Investigative Site

Gatineau, Quebec, Canada

Site Status

Novartis Investigative Site

Clermont-Ferrand, , France

Site Status

Novartis Investigative Site

Lille, , France

Site Status

Novartis Investigative Site

Pessac, , France

Site Status

Novartis Investigative Site

Poitiers, , France

Site Status

Novartis Investigative Site

Beelitz-Heilstätten, , Germany

Site Status

Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Bochum, , Germany

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Novartis Investigative Site

Düsseldorf, , Germany

Site Status

Novartis Investigative Site

Kassel, , Germany

Site Status

Novartis Investigative Site

Leipzig, , Germany

Site Status

Novartis Investigative Site

München, , Germany

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Novartis Investigative Site

München, , Germany

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Novartis Investigative Site

Stadtroda, , Germany

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Novartis Investigative Site

Westerstede/Oldenburg, , Germany

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Novartis Investigative Site

Budapest, , Hungary

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Novartis Investigative Site

Kaposvár, , Hungary

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Novartis Investigative Site

Szeged, , Hungary

Site Status

Novartis Investigative Site

Bolzano, BZ, Italy

Site Status

Novartis Investigative Site

Pisa, PI, Italy

Site Status

Novartis Investigative Site

Roma, RM, Italy

Site Status

Novartis Investigative Site

Sant Cugat del Vallès, Barcelona, Spain

Site Status

Novartis Investigative Site

Barcelona, Catalonia, Spain

Site Status

Novartis Investigative Site

Donostia / San Sebastian, , Spain

Site Status

Novartis Investigative Site

Madrid, , Spain

Site Status

Countries

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United States Canada France Germany Hungary Italy Spain

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.

Reference Type DERIVED
PMID: 27214258 (View on PubMed)

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=9863

Results for CAFQ056A2222 from the Novartis Clinical Trials website

Other Identifiers

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2011-002073-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CAFQ056A2222

Identifier Type: -

Identifier Source: org_study_id