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

NCT01491022 | Completed Phase 1 Results DMC

• 1 other identifier: 20110173
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Parkinson's Disease

Keywords

parkinson's; gait dysfunction; ampyra; 4-aminopyridine

Outcome Measures

Primary Outcomes (1)

• Change in Velocity

  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 Outcomes (5)

• United Parkinson's Disease Rating Scale Score(UPDRS) ,

  4 weeks

• Freezing of Gait Questionnaire (FOGQ)

  4 weeks

• Timed Up and Go (TUG) Score

  4 weeks

• Timed 25-foot Walk Test (T25FW)

  4 weeks

• Change in Stride Legth

  4 weeks

Study Arms (2)

Ampyra

EXPERIMENTAL

Ampyra 10 mg po BID for 4 weeks followed by placebo 4 weeks

Drug: Ampyra first, then Placebo

Placebo

SHAM COMPARATOR

placebo 4 weeks followed by Ampyra 10 mg po BID

Drug: placebo first, then Ampyra

Interventions

Ampyra first, then Placebo DRUG

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

Also known as: first intervention

Ampyra

placebo first, then Ampyra DRUG

placebo

Also known as: second intervention

Placebo

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead
• Acorda Therapeutics: collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Dr Corneliu Luca
• Organization: University of Miami

cluca@med.miami.edu

3052432235

Study Officials

• Corneliu Luca

  University of Miami

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurology Instructor

Study Record Dates

• First Submitted: December 8, 2011
• First Posted: December 13, 2011
• Study Start: July 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: January 2, 2018
• Results First Posted: April 13, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)