A Randomized Trial to Evaluate Ampyra for Gait Impairment in Parkinson's Disease
The purpose of this study is to evaluate the effect of AMPYRA on a number of symptoms in Parkinson's disease. AMPYRA is a medication approved by FDA for gait dysfunction in multiple sclerosis. There are multiple studies to suggest that persons with multiple sclerosis benefit from this medication and have major improvements in gait after taking this medication. However, this medication was never studied in Parkinson's disease. This study aims to learn about possible benefits of AMPYRA in Parkinson's disease (PD).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized Trial to Evaluate Ampyra for Gait Impairment in Parkinson's Disease|
- gait velocity and stride length. [ Time Frame: baseline and 4 weeks ] [ Designated as safety issue: No ]The primary outcome measure will be the change in gait velocity and stride length as measured with by 3-dimensional gait analysis system.
- United Parkinson's Disease Rating Scale score(UPDRS) , [ Time Frame: baseline and 4 weeks ] [ Designated as safety issue: No ]change in UPDRS score (motor)
- Freezing of Gait Questionnaire (FOGQ) [ Time Frame: baseline and 4 weeks ] [ Designated as safety issue: No ]change in FOGQ score
- Timed Up and Go (TUG) score [ Time Frame: baseline and 4 weeks ] [ Designated as safety issue: No ]changes in time required to perform TUG.
- Timed 25-foot Walk test (T25FW) [ Time Frame: baseline and 4 weeks ] [ Designated as safety issue: No ]changes in time required to perform T25FW.
|Study Start Date:||July 2012|
|Study Completion Date:||July 2014|
|Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Ampyra
Ampyra 10 mg po BID
10 mg po bid for 4 weeks
Other Name: AMPYRA
|Placebo Comparator: Placebo||
Subjects with Parkinson's disease will be randomly assigned to two groups. One group will receive Ampyra first for 4 weeks, followed by 2 weeks break and than 4 weeks placebo while the second group will first receive placebo and then Ampyra.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01491022
|United States, Florida|
|University of Miami|
|Miami, Florida, United States, 33136|