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

12-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

NCT01385592

Enrollment

Registered

2011-06-30

Start date

2011-11-30

Completion date

2012-09-30

Last updated

2020-12-23

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

Conditions

Dyskinesias, Movement Disorders, Parkinson Disease, Parkinsonian Disorders

Keywords

Parkinson Disease, L-dopa, Levodopa, Dyskinesia, Anti-Dyskinesia Agents

Brief summary

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

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 * 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 Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Anti-dyskinetic efficacy as measured by the modified AIMS (Abnormal Involuntary Movement Scale) total score. To assess how titration of AFQ056 at 2-week intervals affects tolerability profile	12 weeks

Secondary

Measure	Time frame
Anti-dyskinetic efficacy as measured by the Lang-Fahn Activities of Daily Living Dyskinesia Scale (LFADLDS)	12 weeks
Change from baseline on patient's disability caused by the dyskinesia as assessed by a clinician-rated global impression of change (CGIC)	12 weeks
Total ON- and OFF-times and ON-time with dyskinesia and with troublesome dyskinesias (patient diary)	12 weeks
Anti-dyskinetic efficacy as measured by items 32, 33 and 34 of Part IV of the Unified Parkinson's Disease Rating Scale (UPDRS )	12 weeks
Safety of AFQ056 as measured by changes in vital signs, laboratory values, electrocardiogram and number of Adverse Events	12 weeks

Countries

Canada, France, Germany, Hungary, Italy, Spain, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026