A Randomized Trial to Evaluate Ampyra for Gait Impairment in Parkinson's Disease

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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A Randomized Trial to Evaluate Ampyra for Gait Impairment in Parkinson's Disease

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Drug: Ampyra first, then Placebo
* Drug: placebo first, then Ampyra


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Idiopathic PD with stage Hoehn and Yahr Stage>2-3 and with gait freezing or postural instability. On stable dosage dopamine agonist/levodopa, and expected to remain on the same dosage of treatment for the duration of study Age less than 80, onset of disease at age more than 45. Able to give consent Exclusion Criteria: Past medical history of seizures, History of renal insufficiency, History of cardiac arrhythmia, Severe arthritis, Women of childbearing potential, Cognitive impairment Age more than 80. PD patients stage 4 H&Y PD patient with recent introduction of dopamine agonist or IMAO B PD patients participating in other studies

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ampyra<br>Ampyra 10 mg po BID for 4 weeks followed by placebo 4 weeks | Drug: Ampyra first, then Placebo<br>* 10 mg po bid for 4 weeks followed by placebo 4 weeks.<br>* Other names: first intervention;|
| Sham Comparator: Placebo<br>placebo 4 weeks followed by Ampyra 10 mg po BID | Drug: placebo first, then Ampyra<br>* placebo<br>* Other names: second intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Velocity | The primary outcome measure will be the change in gait velocity as measured with by 3-dimensional gait analysis system. | baseline and 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| United Parkinson's Disease Rating Scale Score(UPDRS) , | change in UPDRS score (motor) range 0-104, where 0 is good and 104 is worse. | 4 weeks | 
| Freezing of Gait Questionnaire (FOGQ) | change in FOGQ score 0- 16, where 0 is normal, 16 is severely impaired | 4 weeks | 
| Timed Up and Go (TUG) Score | time required to perform TUG. | 4 weeks | 
| Timed 25-foot Walk Test (T25FW) | time required to perform T25FW. | 4 weeks | 
| Change in Stride Legth | change in stride length as measured by 3 D capture analysis | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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parkinson's, gait dysfunction, ampyra, 4-aminopyridine