Clinical trial NCT01092065: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson's Disease
Keywords: Parkinson's Disease
Dyskinesia
Drug-induced
Levodopa
L-dopa
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-03-24
Enrollment: 23
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 5 weeks
Secondary outcomes:
measure: Change from baseline to the LOCF endpoint at week 5 in ON time with dyskinesia collected from the Hauser et al. patient diary.
timeFrame: 5 weeks
measure: 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.
timeFrame: 5 weeks
measure: 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.
timeFrame: 5 weeks
measure: 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.
timeFrame: 5 weeks
measure: Safety and tolerability as measured by changes in vital signs, laboratory values, ECGs, and percentages of treatment-emergent AEs and SAEs
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Sunnyvale
country: United States
facility: The Parkinsons Institute
state: California
city: Englewood
country: United States
facility: Colorado Neurological Institute
state: Colorado
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Medical Center - Parkinson's Disease and Movement Disorders Center
state: Kansas
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: