NCT01331122

Study to Assess Droxidopa in the Treatment of Freezing Of Gait Symptoms in Patients With Parkinson's Disease

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

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Chelsea Therapeutics · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Gait Disorders, Neurologic

Interventions

Type	Name	Description
DRUG	droxidopa	Oral, 100, 200, 300, 400, 500, or 600 mg TID, duration includes two crossover periods of up to a 2 week titration period followed by a 4 week treatment period,with a washout between crossover periods.

Timeline

• Start date: 2012-04-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2011-04-07
• Last updated: 2013-03-29

Locations

2 sites across 2 countries: United States, Canada