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 2CompletedNCT01092065

Novartis23 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Parkinson's Disease

Interventions

AFQ056 with L-dopaDRUG

hard gelatin capsule to be taken bid for six weeks

PlaceboDRUG

hard gelatin capsule to be taken bid for six weeks

Eligibility

Sex: ALLMin age: 30 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (4)

The Parkinsons Institute

Sunnyvale, California, 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

Outcomes

Primary Outcomes

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

Time frame: 5 weeks

Secondary Outcomes

Change from baseline to the LOCF endpoint at week 5 in ON time with dyskinesia collected from the Hauser et al. patient diary.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 5 weeks

Safety and tolerability as measured by changes in vital signs, laboratory values, ECGs, and percentages of treatment-emergent AEs and SAEs

Time frame: 5 weeks

Data from ClinicalTrials.gov

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