A Randomized Trial to Evaluate Ampyra for Gait Impairment in Parkinson's Disease
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|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|
|Actual Primary Completion Date :||July 2014|
|Actual 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|