Efficacy and Safety of AFQ056 When Combined With Increased Doses of L-dopa in Parkinson's Disease Patients With Moderate-severe L-dopa Induced Dyskinesia

NCT ID: NCT01092065

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

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-07-31

Brief Summary

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This Phase IIb exploratory study is designed to determine whether AFQ056 is safe and effective and whether it can increase the therapeutic window of L-dopa in patients whose control of their Parkinson's Disease symptoms is limited by the development of dyskinesia induced by use of L-dopa.

Detailed Description

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Conditions

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Parkinson's Disease

Keywords

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Parkinson's Disease Dyskinesia Drug-induced Levodopa L-dopa

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 (Bid)

Group Type EXPERIMENTAL

AFQ056 with L-dopa

Intervention Type DRUG

hard gelatin capsule to be taken bid for six weeks

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

hard gelatin capsule to be taken bid for six weeks

Interventions

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AFQ056 with L-dopa

hard gelatin capsule to be taken bid for six weeks

Intervention Type DRUG

Placebo

hard gelatin capsule to be taken bid for six weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Outpatients with Parkinson's Disease (PD), treated with L-dopa, experiencing OFF time and dyskinesias for at least three months

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) 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

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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The Parkinsons Institute

Sunnyvale, California, United States

Site Status

Colorado Neurological Institute

Englewood, Colorado, United States

Site Status

Indiana University School of Medicine

Indianapolis, Indiana, United States

Site Status

University of Kansas Medical Center - Parkinson's Disease and Movement Disorders Center

Kansas City, Kansas, United States

Site Status

Countries

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United States

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=6483

Results for CAFQ056A2216 from the Novartis Clinical Trials website

Other Identifiers

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CAFQ056A2216

Identifier Type: -

Identifier Source: org_study_id