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

Phase 2

Completed

• Conditions: Parkinson Disease; Parkinsonian Disorders; Dyskinesias; Movement Disorders
• Interventions: Drug: Placebo; Drug: AFQ056

• Registration Number: NCT01385592
• Lead Sponsor: Novartis Pharmaceuticals

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-06-28
• Study First Submitted QC: 2011-06-29
• Study First Posted: 2011-06-30
• Study Start: 2011-11
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2016-03
• Disposition First Submitted: 2016-03-22
• Disposition First Submitted QC: 2016-03-22
• Disposition First Posted: 2016-04-25
• Last Update Submitted: 2020-12-15
• Last Update Posted: 2020-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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/exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
AFQ056 100 mg	AFQ056	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Anti-dyskinetic efficacy as measured by the Lang-Fahn Activities of Daily Living Dyskinesia Scale (LFADLDS)	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
Change from baseline on patient's disability caused by the dyskinesia as assessed by a clinician-rated global impression of change (CGIC)	12 weeks
Safety of AFQ056 as measured by changes in vital signs, laboratory values, electrocardiogram and number of Adverse Events	12 weeks

Trial Locations

Locations (1)

Novartis Investigative Site; 🇪🇸 San Sebastian, Spain