Efficacy and Safety of AFQ056 in Reducing L-dopa Induced Dyskinesias in Parkinson's Disease Patients

A Multi-centre, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multiple Oral Dose Study to Assess the Efficacy and Tolerability of AFQ056 in Reducing L-dopa Induced Dyskinesias in Parkinson's Patients With Severe L-dopa Induced Dyskinesias

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00888004

Enrollment

Registered

2009-04-24

Start date

2009-03-31

Completion date

Unknown

Last updated

2016-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

L-dopa Induced Dyskinesia, Parkinson's Disease

Keywords

Parkinson's, L-dopa, dyskinesia

Brief summary

This study will evaluate the safety and efficacy of administration of AFQ056 in combination with L-dopa, in reducing the number of L-dopa related dyskinesias in Parkinson's disease patients.

Interventions

DRUGAFQ056

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

30 Years to 85 Years

Healthy volunteers

Inclusion criteria

* Patients with Parkinson's Disease * Patients with L-dopa induced dyskinesia for at least 3 months * Patients with L-dopa treatment for at least 3 years, stable for 1 month minimum

Exclusion criteria

* History of severe allergy to food or drugs * Very low or high body weight. * Prior surgery for Parkinson's Disease * Smokers Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Number and severity of Dyskinesias and the safety and tolerability of administering AFQ056 in combination with L-dopa	20 days

Secondary

Measure	Time frame
Safety and tolerability of administration of AFQ056 in combination with L-dopa	20 days

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026