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

This study is currently recruiting participants.
Verified August 2012 by University of Miami
Sponsor:
Collaborator:
Acorda Therapeutics
Information provided by (Responsible Party):
Corneliu C Luca, University of Miami
ClinicalTrials.gov Identifier:
NCT01491022
First received: December 8, 2011
Last updated: August 29, 2012
Last verified: August 2012
History of Changes
  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
Gait Disorders
 Drug: Dalfampridine
Drug: placebo
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by University of Miami:

Primary Outcome Measures:
  • gait velocity and stride length. [ Time Frame: baseline and 4 weeks ] [ Designated as safety issue: No ]
    The primary outcome measure will be the change in gait velocity and stride length as measured with by 3-dimensional gait analysis system.


Secondary Outcome Measures:
  • United Parkinson's Disease Rating Scale score(UPDRS) , [ Time Frame: baseline and 4 weeks ] [ Designated as safety issue: No ]
    change in UPDRS score (motor)

  • Freezing of Gait Questionnaire (FOGQ) [ Time Frame: baseline and 4 weeks ] [ Designated as safety issue: No ]
    change in FOGQ score

  • Timed Up and Go (TUG) score [ Time Frame: baseline and 4 weeks ] [ Designated as safety issue: No ]
    changes in time required to perform TUG.

  • Timed 25-foot Walk test (T25FW) [ Time Frame: baseline and 4 weeks ] [ Designated as safety issue: No ]
    changes in time required to perform T25FW.


Estimated Enrollment: 25
Study Start Date: July 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ampyra
Ampyra 10 mg po BID
 Drug: Dalfampridine
10 mg po bid for 4 weeks
Other Name: AMPYRA
Placebo Comparator: Placebo Drug: placebo
placebo

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

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01491022

Contacts
Contact: Corneliu C Luca, MD, PhD 3052432235 cluca@med.miami.edu

Locations
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Corneliu C Luca, MD, PhD     305-243-2235     cluca@med.miami.edu    
Contact: Monica Quesada     305243 3647     mquesada2@med.miami.edu    
Principal Investigator: Corneliu C Luca, MD, PhD            
Sponsors and Collaborators
University of Miami
Acorda Therapeutics
  More Information

No publications provided

Responsible Party: Corneliu C Luca, Neurology Instructor, University of Miami
ClinicalTrials.gov Identifier: NCT01491022     History of Changes
Other Study ID Numbers: AMPYRA-PD
Study First Received: December 8, 2011
Last Updated: August 29, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by 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
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013