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

Primary Purpose

Parkinson's Disease

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Ampyra first, then Placebo

placebo first, then Ampyra

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring parkinson's, gait dysfunction, ampyra, 4-aminopyridine

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

University of Miami

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Ampyra

Placebo

Arm Description

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

placebo 4 weeks followed by Ampyra 10 mg po BID

Outcomes

Primary Outcome Measures

Change in Velocity

The primary outcome measure will be the change in gait velocity as measured with by 3-dimensional gait analysis system.

Secondary Outcome Measures

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

change in UPDRS score (motor) range 0-104, where 0 is good and 104 is worse.

Freezing of Gait Questionnaire (FOGQ)

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

Timed Up and Go (TUG) Score

time required to perform TUG.

Timed 25-foot Walk Test (T25FW)

time required to perform T25FW.

Change in Stride Legth

change in stride length as measured by 3 D capture analysis

Full Information

NCT ID

NCT01491022

First Posted

December 8, 2011

Last Updated

December 5, 2017

Sponsor

University of Miami

Collaborators

Acorda Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT01491022

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Completed

Study Start Date

July 2012 (undefined)

Primary Completion Date

July 2014 (Actual)

Study Completion Date

July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Miami

Collaborators

Acorda Therapeutics

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson's Disease

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ampyra

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Sham Comparator

Arm Description

placebo 4 weeks followed by Ampyra 10 mg po BID

Intervention Type

Drug

Intervention Name(s)

Ampyra first, then Placebo

Other Intervention Name(s)

first intervention

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

placebo first, then Ampyra

Other Intervention Name(s)

second intervention

Intervention Description

placebo

Primary Outcome Measure Information:

Title

Change in Velocity

Description

The primary outcome measure will be the change in gait velocity as measured with by 3-dimensional gait analysis system.

Time Frame

baseline and 4 weeks

Secondary Outcome Measure Information:

Title

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

Description

change in UPDRS score (motor) range 0-104, where 0 is good and 104 is worse.

Time Frame

4 weeks

Title

Freezing of Gait Questionnaire (FOGQ)

Description

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

Time Frame

4 weeks

Title

Timed Up and Go (TUG) Score

Description

time required to perform TUG.

Time Frame

4 weeks

Title

Timed 25-foot Walk Test (T25FW)

Description

time required to perform T25FW.

Time Frame

4 weeks

Title

Change in Stride Legth

Description

change in stride length as measured by 3 D capture analysis

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Corneliu Luca

Organizational Affiliation

University of Miami

Official's Role

Study Chair

Facility Information:

Facility Name

University of Miami

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

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

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