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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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19 February 2015 |
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Main ID: |
NCT01313845 |
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Date of registration:
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10/03/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of Intravenous Amantadine on Gait Freezing in Parkinson's Disease
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Scientific title:
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Randomized Double-blind Placebo-controlled Trial of Intravenous Amantadine on Gait Freezing in Patients With Parkinson's Disease |
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Date of first enrolment:
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February 2011 |
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Target sample size:
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46 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01313845 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Jinwhan Cho, M.D.,Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Neurology, Samsung Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- the diagnosis of Parkinson's disease according to the United Kingdom Parkinson's
Disease Brain Bank criteria
- presence of freezing of gait and the scores of Freezing of Gait Questionnaire 7 or
more
- having been treated with oral dopamine replacement therapy for 6 months or more
- score of Korean version of mini-mental status examination is 20 or more
Exclusion Criteria:
- presence of significant cognitive dysfunction, behavioral or psychiatric disorders
- presence of severe cardiac disease
- presence of renal failure, seizure, peptic ulcer disease, liver disease,
pheochromocytoma, chronic exhaustive disease, or malignancy
- participation to other clinical trial within 4 weeks
- pregnancy or lactating women
- hypersensitivity to study drugs
- history of intoxication to heavy metals
Age minimum:
30 Years
Age maximum:
79 Years
Gender:
Both
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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: 0.9% sodium chloride
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Drug: amantadine sulfate
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Primary Outcome(s)
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changes in scores on Freezing of Gait Questionnaire
[Time Frame: after completion of 5-day schedule of IV amantadine treatment compared with baseline status]
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Secondary Outcome(s)
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changes in scores on Freezing of Gait Questionnaire
[Time Frame: after 4-weeks of follow-up compared with baseline status]
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changes of scores on the Unified Parkinson's disease Rating Scale Part III
[Time Frame: after completion of IV amantadine treatment compared with baseline status]
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changes of scores on the Unified Parkinson Disease Rating Scale Part III
[Time Frame: after 4- weeks of follow-up compared with baseline status]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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