Evaluation of the Efficacy and Safety of AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease

13-week, Double-blind, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00986414

Enrollment

260

Registered

2009-09-30

Start date

2009-09-30

Completion date

Unknown

Last updated

2017-02-23

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

Conditions

Dyskinesias, Parkinson Disease

Keywords

Parkinson Disease, L-dopa, Levodopa, dyskinesia

Brief summary

This phase IIb study is designed to determine the safe and efficacious dose or dose range of AFQ056 for the treatment of patients with moderate to severe Parkinson's disease with L-Dopa induced dyskinesias.

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 80 Years

Healthy volunteers

Inclusion criteria

* Outpatients with Parkinson's disease (PD), treated with L-Dopa, experiencing 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 Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Change from baseline to endpoint in the modified AIMS (Abnormal Involuntary Movement Scale) total score	12 weeks

Secondary

Measure	Time frame
Disability due to dyskinesias as measured by change from baseline to endpoint in the PDYS-26 (26-Item Parkinson Disease Dyskinesia Scale) total score	12 weeks
Change from baseline on patient's dyskinesia, disability caused by the dyskinesia and the underlying symptoms of PD as assessed by a clinician-rated (CGIC) and a patient-rated (PGIC) global impression of change	12 weeks
Anti-dyskinetic efficacy as measured by items 32 and 33 of Part IV of the UPDRS (Unified Parkinson's Disease Rating Scale)	12 weeks
Worsening of underlying symptoms of PD as measured by: UPDRS Part III; patient diary (dyskinesias); patient/clinician assessments of change in PD symptoms; AEs related to worsening of PD	12 weeks

Countries

Australia, Canada, Finland, France, Germany, Italy, Japan, Spain

Outcome results

None listed

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