Gait Disorders, Neurologic Clinical Trial
Official title:
A Phase II, Double-Blind, Placebo-Controlled Randomized Crossover Study to Assess the Clinical Benefit and Safety of Droxidopa in the Treatment of Freezing of Gait Symptoms in Patients With Parkinson's Disease
Freezing of Gait (FoG) is a class of symptoms that occur in Parkinson's patients. Also
called motor blocks, FoG is characterized by a sudden inability to move the lower
extremities which usually lasts less than 10 seconds. The exact pathophysiology of FoG is
poorly understood, but treatment with levodopa appears to improve FoG observed in the
off-state. As Parkinson's patients progress in severity, FoG in the on-state can increase in
frequency and appears to be resistant to dopaminergic therapies. There is additional
evidence that norepinephrine as well as dopaminergic systems may be involved in FoG.
Droxidopa has has been approved for use in Japan since 1989 for treatment of frozen gait or
dizziness associated with Parkinson's Disease. This study is to further explore the safety
and efficacy of droxidopa in this indication.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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