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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Parkinson's Disease

In brief

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).

Key facts

Study ID

NCT01491022

Run by

University of Miami

People needed

22

Starts

2012-07-01

Expected to finish

2014-07-01

Last updated by the study team

2018-01-02

Who can join

Age: 45 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Miami — Miami, Florida, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.