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

Phase 2

Completed

• Conditions: Parkinson Disease; Dyskinesias
• Interventions: Drug: AFQ056; Drug: Placebo

• Registration Number: NCT00986414
• Lead Sponsor: Novartis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-29
• Study First Submitted QC: 2009-09-29
• Study First Posted: 2009-09-30
• Primary Completion: 2010-12
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-20
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

• Outpatients with Parkinson's disease (PD), treated with L-Dopa, experiencing dyskinesias for at least three months

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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/exclusion criteria may apply

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AFQ056-10mg	AFQ056	-
AFQ056-25mg	AFQ056	-
AFQ056-50mg	AFQ056	-
AFQ056-75mg	AFQ056	-
AFQ056-100mg	AFQ056	-
Placebo	Placebo	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (8)

Toronto Western Hospital, UHN; 🇨🇦 Toronto, Canada

Novartis Investigative Site; 🇪🇸 San Sebastian, Spain

Novartis Investigational Site; 🇦🇺 Westmead, Australia

Recherches Pembina, Inc; 🇨🇦 Greenfield Park, Canada

Quebec Memory & Motor Skills Disorders Clinic; 🇨🇦 Quebec, Canada

Parkinson's and Neurodegenerative Disorders Clinic; 🇨🇦 Ottawa, Canada

Novartis Investigative SIte; 🇯🇵 Tokyo, Japan

Clinique Neuro-Outaouais; 🇨🇦 Gatineau, Canada