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| Name | Class |
|---|---|
| Acorda Therapeutics | INDUSTRY |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ampyra | Experimental | Ampyra 10 mg po BID for 4 weeks followed by placebo 4 weeks |
|
| Placebo | Sham Comparator | placebo 4 weeks followed by Ampyra 10 mg po BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ampyra first, then Placebo | Drug | 10 mg po bid for 4 weeks followed by placebo 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Freezing of Gait Questionnaire (FOGQ) | change in FOGQ score 0- 16, where 0 is normal, 16 is severely impaired |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Corneliu Luca | University of Miami | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ampyra Then Placebo | Ampyra 10 mg po BID for 4 weeks followed by 2 weeks washout followed by 4 weeks placebo |
| FG001 | Placebo Then Ampyra | placebo for 4 weeks followed by 2 weeks washout followed by 4 weeks Ampyra 10 mg po BID |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intervention 1 |
| |||||||||||||
| 2 Week Washout |
| |||||||||||||
| Intervention 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ampyra Then Placebo | Ampyra 10 mg po BID for 4 weeks followed by 2 weeks washout followed by 4 weeks placebo |
| BG001 | Placebo Then Ampyra | Placebo for 4 weeks followed by 2 weeks washout followed by Ampyra 10 mg po bid for 4 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Velocity | The primary outcome measure will be the change in gait velocity as measured with by 3-dimensional gait analysis system. | Posted | Mean | Standard Deviation | m/s | baseline and 4 weeks |
|
|
at 10 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ampyra | Ampyra 10 mg po BID Dalfampridine: 10 mg po bid for 4 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| dizzines | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Corneliu Luca | University of Miami | 3052432235 | cluca@med.miami.edu |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| placebo first, then Ampyra | Drug | placebo |
|
|
| 4 weeks |
| Timed Up and Go (TUG) Score | time required to perform TUG. | 4 weeks |
| Timed 25-foot Walk Test (T25FW) | time required to perform T25FW. | 4 weeks |
| Change in Stride Legth | change in stride length as measured by 3 D capture analysis | 4 weeks |
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| NOT COMPLETED |
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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| 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. | Posted | Mean | Standard Error | units on a scale | 4 weeks |
|
|
|
| Secondary | Freezing of Gait Questionnaire (FOGQ) | change in FOGQ score 0- 16, where 0 is normal, 16 is severely impaired | Posted | Mean | Standard Deviation | units on a scale | 4 weeks |
|
|
|
| Secondary | Timed Up and Go (TUG) Score | time required to perform TUG. | Posted | Mean | Standard Error | seconds | 4 weeks |
|
|
|
| Secondary | Timed 25-foot Walk Test (T25FW) | time required to perform T25FW. | Posted | Mean | Standard Error | seconds | 4 weeks |
|
|
|
| Secondary | Change in Stride Legth | change in stride length as measured by 3 D capture analysis | Posted | Mean | Standard Deviation | meters | 4 weeks |
|
|
|
| 0 |
| 22 |
| 5 |
| 22 |
| EG001 | Placebo | placebo: placebo | 0 | 22 | 2 | 22 |
| urinary tract infection | Infections and infestations | Non-systematic Assessment |
|
| balance worsening | Nervous system disorders | Non-systematic Assessment |
|
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |