drugset / Trial / NCT01331122

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

NCT01331122

Phase 1/2 Withdrawn Chelsea Therapeutics
RandomizedCrossoverDouble-blindTreatment

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.

Timeline

Start
2012-04
Primary completion
2012-12
Completion
2012-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Droxidopa Small molecule 100 mg Oral
Subject Droxidopa Small molecule 200 mg Oral
Subject Droxidopa Small molecule 300 mg Oral
Subject Droxidopa Small molecule 400 mg Oral
Subject Droxidopa Small molecule 500 mg Oral
Subject Droxidopa Small molecule 600 mg Oral

Indications