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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01491022
• Other study ID #: 20110173
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 8, 2011
• Last updated: December 5, 2017
• Start date: July 2012
• Est. completion date: July 2014

Study information

• Verified date: December 2017
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Ampyra first, then Placebo
10 mg po bid for 4 weeks followed by placebo 4 weeks.
• placebo first, then Ampyra
placebo

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Acorda Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	United Parkinson's Disease Rating Scale Score(UPDRS) ,	change in UPDRS score (motor) range 0-104, where 0 is good and 104 is worse.	4 weeks
Secondary	Freezing of Gait Questionnaire (FOGQ)	change in FOGQ score 0- 16, where 0 is normal, 16 is severely impaired	4 weeks
Secondary	Timed Up and Go (TUG) Score	time required to perform TUG.	4 weeks
Secondary	Timed 25-foot Walk Test (T25FW)	time required to perform T25FW.	4 weeks
Secondary	Change in Stride Legth	change in stride length as measured by 3 D capture analysis	4 weeks