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

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

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'

Brief 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.


Detailed Summary:
Sponsor: Chelsea Therapeutics

Current Primary Outcome: Evaluate the safety of droxidopa as measured by the incidence, relatedness, and severity of adverse events. [ Time Frame: 18 Weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Evaluate the effect of droxidopa on freezing of gait symptoms using the Freezing of Gait Questionnaire [ Time Frame: 18 Weeks ]
  • Evaluate the efficacy of droxidopa in the treatment of freezing of gait by using the Observed Freezing of Gait Rating (OFGR) scale [ Time Frame: 18 Weeks ]
  • Evaluate the effect of droxidopa on signs and symptoms associated with Parkinson's Disease utilizing the composite scores of the Unified Parkinson's Disease Rating Scale [ Time Frame: 18 Weeks ]


Original Secondary Outcome: Same as current

Information By: Chelsea Therapeutics

Dates:
Date Received: October 13, 2010
Date Started: April 2012
Date Completion: December 2012
Last Updated: March 27, 2013
Last Verified: March 2013