A Randomized Trial to Evaluate Ampyra for Gait Impairment in Parkinson's Disease
|ClinicalTrials.gov Identifier: NCT01491022|
Recruitment Status : Completed
First Posted : December 13, 2011
Results First Posted : April 13, 2017
Last Update Posted : January 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease||Drug: Ampyra first, then Placebo Drug: placebo first, then Ampyra||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized Trial to Evaluate Ampyra for Gait Impairment in Parkinson's Disease|
|Study Start Date :||July 2012|
|Primary Completion Date :||July 2014|
|Study Completion Date :||July 2014|
Ampyra 10 mg po BID for 4 weeks followed by placebo 4 weeks
Drug: Ampyra first, then Placebo
10 mg po bid for 4 weeks followed by placebo 4 weeks.
Other Name: first intervention
Sham Comparator: Placebo
placebo 4 weeks followed by Ampyra 10 mg po BID
Drug: placebo first, then Ampyra
Other Name: second intervention
- Change in Velocity [ Time Frame: baseline and 4 weeks ]The primary outcome measure will be the change in gait velocity as measured with by 3-dimensional gait analysis system.
- United Parkinson's Disease Rating Scale Score(UPDRS) , [ Time Frame: 4 weeks ]change in UPDRS score (motor) range 0-104, where 0 is good and 104 is worse.
- Freezing of Gait Questionnaire (FOGQ) [ Time Frame: 4 weeks ]change in FOGQ score 0- 16, where 0 is normal, 16 is severely impaired
- Timed Up and Go (TUG) Score [ Time Frame: 4 weeks ]time required to perform TUG.
- Timed 25-foot Walk Test (T25FW) [ Time Frame: 4 weeks ]time required to perform T25FW.
- Change in Stride Legth [ Time Frame: 4 weeks ]change in stride length as measured by 3 D capture analysis
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01491022
|United States, Florida|
|University of Miami|
|Miami, Florida, United States, 33136|
|Study Chair:||Corneliu Luca||University of Miami|