We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01491022
First Posted: December 13, 2011
Last Update Posted: April 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Acorda Therapeutics
Information provided by (Responsible Party):
Corneliu C Luca, University of Miami
  Purpose
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).

Condition Intervention Phase
Parkinson's Disease Drug: Ampyra first, then Placebo Drug: placebo first, then Ampyra Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Trial to Evaluate Ampyra for Gait Impairment in Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by Corneliu C Luca, University of Miami:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.

  • Freezing of Gait Questionnaire (FOGQ) [ Time Frame: 4 weeks ]
    change in FOGQ score 0- 16, where 0 is normal, 16 is severely impaired

  • Timed Up and Go (TUG) Score [ Time Frame: 4 weeks ]
    time required to perform TUG.

  • Timed 25-foot Walk Test (T25FW) [ Time Frame: 4 weeks ]
    time required to perform T25FW.

  • Change in Stride Legth [ Time Frame: 4 weeks ]
    change in stride length as measured by 3 D capture analysis


Enrollment: 22
Study Start Date: July 2012
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: first intervention
Sham Comparator: Placebo
placebo 4 weeks followed by Ampyra 10 mg po BID
Drug: placebo first, then Ampyra
placebo
Other Name: second intervention

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   45 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Idiopathic PD with stage Hoehn and Yahr Stage>1-3 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01491022


Locations
United States, Florida
University of Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Acorda Therapeutics
Investigators
Study Chair: Corneliu Luca University of Miami
  More Information

Responsible Party: Corneliu C Luca, Neurology Instructor, University of Miami
ClinicalTrials.gov Identifier: NCT01491022     History of Changes
Other Study ID Numbers: 20110173
First Submitted: December 8, 2011
First Posted: December 13, 2011
Results First Submitted: March 2, 2016
Results First Posted: April 13, 2017
Last Update Posted: April 13, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Corneliu C Luca, University of Miami:
parkinson's
gait dysfunction
ampyra
4-aminopyridine

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
4-Aminopyridine
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action