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Randomized Double-blind Placebo-controlled Trial of Intravenous Amantadine on Gait Freezing in Patients With Parkinson's Disease
A double-blinded randomized placebo-controlled trial of intravenous amantadine on gait freezing refractory to oral anti-parkinsonian medications in patients with Parkinson's disease. * administration of IV amantadine or normal saline for 5 days, 2 times a day while keeping current oral anti-parkinsonian medications unchanged * follow-up after administration of IV amantadine for 4 weeks * allocation ratio of amantadine:normal saline is 2:1
Intravenous amantadine is known to be effective for parkinsonian motor symptoms abruptly aggravated and for disabling motor symptoms from severe motor fluctuation and dyskinesia in patients with Parkinson's disease. The study investigators experienced several open label cases who were benefit from intravenous amantadine in their parkinsonian motor symptoms and freezing of gait as well. In addition, there is a pilot open label trial in parkinsonian patients with refractory freezing of gait which showed marked benefit in patients with Parkinson's disease, but not in patients with parkinson-plus syndromes. This study was aimed to evaluate the efficacy of intravenous amantadine in both levodopa-unresponsive freezing of gait and disabling off state freezing of gait in patients with Parkinson's disease.
Age
30 - 79 years
Sex
ALL
Healthy Volunteers
No
Seoul National University Bundang Hospital
Seongnam, South Korea
Hanyang University Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul National University Boramae Hospital
Seoul, South Korea
Start Date
February 1, 2011
Primary Completion Date
June 1, 2012
Completion Date
June 1, 2012
Last Updated
August 9, 2012
46
ACTUAL participants
amantadine sulfate
DRUG
0.9% sodium chloride
DRUG
Lead Sponsor
Jee-Young Lee
Collaborators
NCT07310264
NCT02119611
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT07216976