Status:
COMPLETED
A Randomized Trial to Evaluate Ampyra for Gait Impairment in Parkinson's Disease
Lead Sponsor:
University of Miami
Collaborating Sponsors:
Acorda Therapeutics
Conditions:
Parkinson's Disease
Eligibility:
All Genders
45-80 years
Phase:
PHASE1
PHASE2
Brief Summary
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 a...
Detailed Description
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 wi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01491022
Start Date
July 1 2012
End Date
July 1 2014
Last Update
January 2 2018
Active Locations (1)
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1
University of Miami
Miami, Florida, United States, 33136