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

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

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 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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Miami
• Collaborator: Acorda Therapeutics
• Treatments: 4-Aminopyridine

Criteria

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