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

University of Miami

Status and phase: Completed; Phase 2; Phase 1

Conditions: Parkinson's Disease

Treatments: Drug: placebo first, then Ampyra; Drug: Ampyra first, then Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01491022

20110173

Details and patient eligibility

About

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).

Full 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 will first receive placebo and then Ampyra.

Enrollment: 22 patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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22 participants in 2 patient groups

Ampyra

Experimental group

Description:

Ampyra 10 mg po BID for 4 weeks followed by placebo 4 weeks

Treatment:

Drug: Ampyra first, then Placebo

Placebo

Sham Comparator group

Description:

placebo 4 weeks followed by Ampyra 10 mg po BID

Treatment:

Drug: placebo first, then Ampyra