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

NCT01491022 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2018-01-02

Study results available
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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).

Conditions

Interventions

DRUG

Ampyra first, then Placebo

10 mg po bid for 4 weeks followed by placebo 4 weeks.

DRUG

placebo first, then Ampyra

placebo

Sponsors & Collaborators

  • Acorda Therapeutics

    collaborator INDUSTRY

  • University of Miami

    lead OTHER

Principal Investigators

  • Corneliu Luca · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
45 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01491022 on ClinicalTrials.gov