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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.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT01313845
Date of registration: 10/03/2011
Prospective Registration: Yes
Primary sponsor: Jee-Young Lee
Public title: Effect of Intravenous Amantadine on Gait Freezing in Parkinson's Disease
Scientific title: Randomized Double-blind Placebo-controlled Trial of Intravenous Amantadine on Gait Freezing in Patients With Parkinson's Disease
Date of first enrolment: February 2011
Target sample size: 46
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT01313845
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment  
Phase:  Phase 4
Countries of recruitment
Korea, Republic of
Contacts
Name:     Jinwhan Cho, M.D.,Ph.D.
Address: 
Telephone:
Email:
Affiliation:  Department of Neurology, Samsung Medical Center
Key inclusion & exclusion criteria

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
Health Condition(s) or Problem(s) studied
Parkinson's Disease
Intervention(s)
Drug: 0.9% sodium chloride
Drug: amantadine sulfate
Primary Outcome(s)
changes in scores on Freezing of Gait Questionnaire [Time Frame: after completion of 5-day schedule of IV amantadine treatment compared with baseline status]
Secondary Outcome(s)
changes in scores on Freezing of Gait Questionnaire [Time Frame: after 4-weeks of follow-up compared with baseline status]
changes of scores on the Unified Parkinson Disease Rating Scale Part III [Time Frame: after 4- weeks of follow-up compared with baseline status]
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]
Secondary ID(s)
SB11F001
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Hanyang University
Samsung Medical Center
Seoul National University Boramae Hospital
Seoul National University Bundang Hospital
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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