Parkinson's Disease
Conditions
Keywords
parkinson's, gait dysfunction, ampyra, 4-aminopyridine
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.
Interventions
DRUGAmpyra first, then Placebo
10 mg po bid for 4 weeks followed by placebo 4 weeks.
DRUGplacebo first, then Ampyra
placebo
Sponsors
Acorda Therapeutics
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Velocity | 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
| Measure | Time frame | Description |
|---|---|---|
| United Parkinson's Disease Rating Scale Score(UPDRS) , | 4 weeks | change in UPDRS score (motor) range 0-104, where 0 is good and 104 is worse. |
| Freezing of Gait Questionnaire (FOGQ) | 4 weeks | change in FOGQ score 0- 16, where 0 is normal, 16 is severely impaired |
| Timed Up and Go (TUG) Score | 4 weeks | time required to perform TUG. |
| Timed 25-foot Walk Test (T25FW) | 4 weeks | time required to perform T25FW. |
| Change in Stride Legth | 4 weeks | change in stride length as measured by 3 D capture analysis |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ampyra Then Placebo Ampyra 10 mg po BID for 4 weeks followed by 2 weeks washout followed by 4 weeks placebo | 10 |
| Placebo Then Ampyra Placebo for 4 weeks followed by 2 weeks washout followed by Ampyra 10 mg po bid for 4 weeks | 12 |
| Total | 22 |
Baseline characteristics
| Characteristic | Ampyra Then Placebo | Placebo Then Ampyra | Total |
|---|---|---|---|
| Age, Continuous | 67.6 years STANDARD_DEVIATION 10.8 | 67.4 years STANDARD_DEVIATION 5.9 | 67.5 years STANDARD_DEVIATION 8.7 |
| Sex: Female, Male Female | 1 Participants | 4 Participants | 5 Participants |
| Sex: Female, Male Male | 9 Participants | 8 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 22 | 2 / 22 |
| serious Total, serious adverse events | 0 / 22 | 0 / 22 |
Outcome results
Primary
Change in Velocity
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ampyra | Change in Velocity | 0.03 m/s | Standard Deviation 0.03 |
| Placebo | Change in Velocity | 0.05 m/s | Standard Deviation 0.03 |
Secondary
Change in Stride Legth
change in stride length as measured by 3 D capture analysis
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ampyra | Change in Stride Legth | -0.01 meters | Standard Deviation 0.04 |
| Placebo | Change in Stride Legth | 0.05 meters | Standard Deviation 0.04 |
Secondary
Freezing of Gait Questionnaire (FOGQ)
change in FOGQ score 0- 16, where 0 is normal, 16 is severely impaired
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ampyra | Freezing of Gait Questionnaire (FOGQ) | 13.16 units on a scale | Standard Deviation 4.9 |
| Placebo | Freezing of Gait Questionnaire (FOGQ) | 13.4 units on a scale | Standard Deviation 3.7 |
Secondary
Timed 25-foot Walk Test (T25FW)
time required to perform T25FW.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ampyra | Timed 25-foot Walk Test (T25FW) | 11.6 seconds | Standard Error 5 |
| Placebo | Timed 25-foot Walk Test (T25FW) | 11.8 seconds | Standard Error 6.5 |
Secondary
Timed Up and Go (TUG) Score
time required to perform TUG.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ampyra | Timed Up and Go (TUG) Score | 23.25 seconds | Standard Error 15.4 |
| Placebo | Timed Up and Go (TUG) Score | 20.6 seconds | Standard Error 15.3 |
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.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ampyra | United Parkinson's Disease Rating Scale Score(UPDRS) , | 35.22 units on a scale | Standard Error 14.4 |
| Placebo | United Parkinson's Disease Rating Scale Score(UPDRS) , | 35.55 units on a scale | Standard Error 13.7 |