Parkinson's Disease Clinical Trial
Official title:
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.
;
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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