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

Parkinson's Disease Clinical Trial

Official title:

A 6-week, Double-blind, Placebo-controlled, Randomized, Multicenter Study to Explore the Efficacy and Safety of AFQ056 When Combined With Increased Doses of L-dopa in Parkinson's Disease Patients With OFF Time and Moderate-severe L-dopa Induced Dyskinesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01092065
• Other study ID #: CAFQ056A2216
• Status: Completed
• Phase: Phase 2
• Start date: March 2010
• Est. completion date: July 2011

Study information

• Verified date: March 2013
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria:

• Outpatients with Parkinson's Disease (PD), treated with L-dopa, experiencing OFF time and 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/exclusion criteria may apply

Related Conditions & MeSH terms

• Dyskinesias
• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• AFQ056 with L-dopa
hard gelatin capsule to be taken bid for six weeks
• Placebo
hard gelatin capsule to be taken bid for six weeks

Locations

Country	Name	City	State
United States	Colorado Neurological Institute	Englewood	Colorado
United States	Indiana University School of Medicine	Indianapolis	Indiana
United States	University of Kansas Medical Center - Parkinson's Disease and Movement Disorders Center	Kansas City	Kansas
United States	The Parkinsons Institute	Sunnyvale	California

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Safety and tolerability as measured by changes in vital signs, laboratory values, ECGs, and percentages of treatment-emergent AEs and SAEs		5 weeks

External Links

•   Results for CAFQ056A2216 from the Novartis Clinical Trials website