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NCT Number: NCT01491022

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

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).

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Miami

Miami, Florida, 33136, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ampyra first, then Placebo

Drug

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

Other names: first intervention

placebo first, then Ampyra

Drug

placebo

Other names: second intervention

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. Freezing of Gait Questionnaire (FOGQ)

    Time frame: 4 weeks

    change in FOGQ score 0- 16, where 0 is normal, 16 is severely impaired

  3. Timed Up and Go (TUG) Score

    Time frame: 4 weeks

    time required to perform TUG.

  4. Timed 25-foot Walk Test (T25FW)

    Time frame: 4 weeks

    time required to perform T25FW.

  5. Change in Stride Legth

    Time frame: 4 weeks

    change in stride length as measured by 3 D capture analysis

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • Acorda Therapeutics

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Dec 13, 2011
Registry last updated
Jan 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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