Since droxidopa has been approved in Japan for treating freezing of gait in Parkinson's disease patients, this is to confirm and further investigate the safety and efficacy using a similar dose. The possible beneficial effects on cognition in mildly cognitively impaired Parkinson's disease patients will also be tested, since this problem in Parkinson's disease may be associated with decreased brain synthesis of norepinephrine (a neurotransmitter associated with multiple brain functions). During this 11 week study, droxidopa will be slowly titrated up to 600 mg daily. Walking and freezing of gait will be evaluated and rated. Cognitive functions will be evaluated by a computer-based program.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
20
Droxidopa will be supplied in 100 and 200 mg pill sizes. The proposed dosing is 100mg twice daily at baseline, then titrate to 200 mg twice daily at day 7 and then titrate to 300mg twice daily at day 14. Subjects will stay on the 600mg daily for 2 weeks. Total exposure 28 days of study drug.
Sugar pill or placebo will be supplied in pill sizes matched to droxidopa formulation. The study titration will be the same. Sugar pills will be used for 5 weeks during the study.
Rush University Medical Center
Chicago, Illinois, United States
Henry Ford Hospital, West Bloomfield
West Bloomfield, Michigan, United States
Change from baseline in freezing of gait symptoms using Freezing of Gait Questionnaire
Evaluate the effect of droxidopa on freezing of gait symptoms using the Freezing of Gait Questionnaire completed by patients. All measures will be performed at baseline and after two and four weeks of study medication.
Time frame: 4 weeks
Change from baseline in cognitive testing
Battery of cognitive testing is performed. All measures will be performed at baseline and after two and four weeks of study medication.
Time frame: 4 weeks
Change in measurement of freezing of gait
Videotaped evaluations quantifying the number of episodes of freezing of gait and their severity will be rated using the Observed Freezing of Gait scale. The Timed Up and Go test will evaluate the effect of droxidopa on PD symptoms. The effect of droxidopa treatment on gait features of stride, swing time variability, and gait asymmetry will be analyzed. All measures will be performed at baseline and after two and four weeks of study medication.
Time frame: 4 weeks
Change in the incidence of falls
Videotaped evaluations quantifying the number of fall episodes will be rated using the Observed Freezing of Gait scale. The Timed Up and Go test will evaluate the effect of droxidopa on PD symptoms and freezing of gait. The effect of droxidopa on falls will be analyzed using the GaitRite system. All measures will be performed at baseline and after two and four weeks of study medication.
Time frame: 4 weeks
Change in signs and symptoms of Parkinson's disease
The UPDRS (Unified Parkinson's Disease Rating Scale) will be performed at baseline and after 2 and 4 weeks on study drug for each arm.
Time frame: 4 weeks
Number of participants with serious and non-serious adverse events
Safety of droxidopa will be evaluated based on the occurrence of treatment emergent adverse events with specific evaluation of blood pressure, heart rate , ECG, suicidality, and laboratory findings across the study
Time frame: up to 11 weeks
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