Efficacy and Safety of AFQ056 When Combined With Increased Doses of L-dopa in Parkinson's Disease Patients With Moderate-severe L-dopa Induced Dyskinesia

Phase 2

Completed

• Conditions: Parkinson's Disease
• Interventions: Drug: AFQ056 with L-dopa; Drug: Placebo

• Registration Number: NCT01092065
• Lead Sponsor: Novartis

Brief Summary

This Phase IIb exploratory study is designed to determine whether AFQ056 is safe and effective and whether it can increase the therapeutic window of L-dopa in patients whose control of their Parkinson's Disease symptoms is limited by the development of dyskinesia induced by use of L-dopa.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-22
• Study First Submitted QC: 2010-03-23
• Study First Posted: 2010-03-24
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Disposition First Submitted: 2013-02-18
• Disposition First Submitted QC: 2013-02-18
• Disposition First Posted: 2013-02-22
• Status Verified: 2013-03
• Last Update Submitted: 2020-12-15
• Last Update Posted: 2020-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• Outpatients with Parkinson's Disease (PD), treated with L-dopa, experiencing OFF time and dyskinesias for at least three months

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AFQ056 100 mg (Bid)	AFQ056 with L-dopa	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change from baseline to the last-observation-carried-forward (LOCF) endpoint at week 5 in total OFF time collected from the Hauser et al. patient diary	5 weeks

Secondary Outcome Measures

Name	Time	Method
Change from baseline to the LOCF endpoint at week 5 in ON time with dyskinesia collected from the Hauser et al. patient diary.	5 weeks
Effect of increasing L-dopa doses on the underlying symptoms of Parkinson's Disease (PD) as measured by the United Parkinson's Disease Rating Scale (UPDRS) Part III.	5 weeks
Change in dyskinesia from baseline to the LOCF endpoint at week 5 as measured by the modified Abnormal Involuntary Movement Scale (AIMS), patient diary and Unified Dyskinesia Rating Scale (UDysRS) Parts I-IV.	5 weeks
Change from baseline on patient's dyskinesia, disability caused by dyskinesia and the underlying symptoms of PD as assessed by a clinician-rated (CGIC) and a patient-rated (PGIC) global impression of change.	5 weeks
Safety and tolerability as measured by changes in vital signs, laboratory values, ECGs, and percentages of treatment-emergent AEs and SAEs	5 weeks

Trial Locations

Locations (4)

The Parkinsons Institute; 🇺🇸 Sunnyvale, California, United States

Colorado Neurological Institute; 🇺🇸 Englewood, Colorado, United States

University of Kansas Medical Center - Parkinson's Disease and Movement Disorders Center; 🇺🇸 Kansas City, Kansas, United States

Indiana University School of Medicine; 🇺🇸 Indianapolis, Indiana, United States