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

December 5, 2017 updated by: Corneliu C Luca, University of Miami
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Ampyra
Ampyra 10 mg po BID for 4 weeks followed by placebo 4 weeks
Drug: Ampyra first, then Placebo
10 mg po bid for 4 weeks followed by placebo 4 weeks.
Other Names:
  • first intervention
SHAM_COMPARATOR: Placebo
placebo 4 weeks followed by Ampyra 10 mg po BID
Drug: placebo first, then Ampyra
placebo
Other Names:
  • second intervention

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Collaborators

Acorda Therapeutics

Investigators

  • Study Chair: Corneliu Luca, University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (ACTUAL)

July 1, 2014

Study Completion (ACTUAL)

July 1, 2014

Study Registration Dates

First Submitted

December 8, 2011

First Submitted That Met QC Criteria

December 12, 2011

First Posted (ESTIMATE)

December 13, 2011

Study Record Updates

Last Update Posted (ACTUAL)

January 2, 2018

Last Update Submitted That Met QC Criteria

December 5, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20110173

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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