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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT01491022 |
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Date of registration:
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08/12/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Randomized Trial to Evaluate Ampyra for Gait Impairment in Parkinson's Disease
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Scientific title:
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A Randomized Trial to Evaluate Ampyra for Gait Impairment in Parkinson's Disease |
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Date of first enrolment:
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July 2012 |
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Target sample size:
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22 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01491022 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Corneliu Luca |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Miami |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Idiopathic PD with stage Hoehn and Yahr Stage>1-3 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
Age minimum:
45 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Parkinson's Disease
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Intervention(s)
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Drug: Ampyra first, then Placebo
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Drug: placebo first, then Ampyra
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Primary Outcome(s)
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Change in Velocity
[Time Frame: baseline and 4 weeks]
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Secondary Outcome(s)
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Timed Up and Go (TUG) Score
[Time Frame: 4 weeks]
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United Parkinson's Disease Rating Scale Score(UPDRS) ,
[Time Frame: 4 weeks]
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Freezing of Gait Questionnaire (FOGQ)
[Time Frame: 4 weeks]
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Timed 25-foot Walk Test (T25FW)
[Time Frame: 4 weeks]
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Change in Stride Legth
[Time Frame: 4 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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