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A Randomized Trial to Evaluate Ampyra for Gait Impairment in Parkinson's Disease | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

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

NCT01491022•University of Miami

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).

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

Age

45 - 80 years

Sex

ALL

Healthy Volunteers

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

Locations (1)

University of Miami

Miami, Florida, United States

Key Dates

Start Date

July 1, 2012

Primary Completion Date

July 1, 2014

Completion Date

July 1, 2014

Last Updated

January 2, 2018

Enrollment

ACTUAL participants

Conditions

Parkinson's Disease

Interventions

Ampyra first, then Placebo

DRUG

placebo first, then Ampyra

DRUG

Deep Brain Stimulation Therapy in Movement Disorders

NCT02119611

Parkinson's Disease

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RECRUITINGPHASE1

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

NCT07310264

Healthy Volunteers (HV)Parkinson's Disease (PD)

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RECRUITINGNA

Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 2, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Deep Brain Stimulation Therapy in Movement Disorders

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study

A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease

Effect of Striatal Temporal Interference Stimulation on Language Processing in Neurodegenerative Diseases

SAD Study in Patients With Parkinson's Disease and Motor Fluctuations