A Randomized Trial to Evaluate Ampyra for Gait Impairment in Parkinson's Disease
| Status: | Completed |
|---|---|
| Conditions: | Parkinsons Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 45 - 80 |
| Updated: | 1/3/2018 |
| Start Date: | July 2012 |
| End Date: | July 2014 |
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).
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).
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.
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.
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
We found this trial at
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University of Miami A private research university with more than 15,000 students from around the...
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