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

Phase 1

Completed

• Conditions: Parkinson's Disease
• Interventions: Drug: Ampyra first, then Placebo; Drug: placebo first, then Ampyra

• Registration Number: NCT01491022
• Lead Sponsor: University of Miami

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 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).

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 will first receive placebo and then Ampyra.

Study Timeline

• Study First Submitted: 2011-12-08
• Study First Submitted QC: 2011-12-12
• Study First Posted: 2011-12-13
• Study Start: 2012-07
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Results First Submitted: 2016-03-02
• Results First Submitted QC: 2017-03-01
• Results First Posted: 2017-04-13
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-05
• Last Update Posted: 2018-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ampyra	Ampyra first, then Placebo	Ampyra 10 mg po BID for 4 weeks followed by placebo 4 weeks
Placebo	placebo first, then Ampyra	placebo 4 weeks followed by Ampyra 10 mg po BID

Primary Outcome Measures

Name	Time	Method
Change in Velocity	baseline and 4 weeks	The primary outcome measure will be the change in gait velocity as measured with by 3-dimensional gait analysis system.

Secondary Outcome Measures

Name	Time	Method
Timed Up and Go (TUG) Score	4 weeks	time required to perform TUG.
Freezing of Gait Questionnaire (FOGQ)	4 weeks	change in FOGQ score 0- 16, where 0 is normal, 16 is severely impaired
United Parkinson's Disease Rating Scale Score(UPDRS) ,	4 weeks	change in UPDRS score (motor) range 0-104, where 0 is good and 104 is worse.
Timed 25-foot Walk Test (T25FW)	4 weeks	time required to perform T25FW.
Change in Stride Legth	4 weeks	change in stride length as measured by 3 D capture analysis

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States