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Norepinephrine Precursor

sugar pill, then droxidopa for Freezing of Gait

Phase 2
Waitlist Available
Led By Peter LeWitt, M.D.
Research Sponsored by Henry Ford Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 11 weeks
Awards & highlights

Study Summary

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.

Eligible Conditions
  • Freezing of Gait
  • Cognitive Ability
  • Parkinson's Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 11 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 11 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in cognitive testing
Change from baseline in freezing of gait symptoms using Freezing of Gait Questionnaire
Secondary outcome measures
Change in measurement of freezing of gait
Change in signs and symptoms of Parkinson's disease
Change in the incidence of falls
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: sugar pill, then droxidopaExperimental Treatment2 Interventions
Subject will be be on sugar pill for 5 weeks (4 weeks of placebo treatment and one week of wash-out or sugar pills). Then, droxidopa will be titrated over 2 week period up to 300 mg twice daily (600 mg total daily dose). Subjects will be titrated to highest tolerated dose and will continue on that dose for two weeks.
Group II: droxidopa, then sugar pillExperimental Treatment2 Interventions
Droxidopa will be titrated over a 2-week period up to 300 mg twice daily (600 mg total daily dose). Subjects will be titrated to highest tolerated dose and will continue on that dose for two weeks. Then, the subject will start sugar pills.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
sugar pill
2013
Completed Phase 4
~1630
Droxidopa
FDA approved

Find a Location

Who is running the clinical trial?

Henry Ford Health SystemLead Sponsor
300 Previous Clinical Trials
2,099,979 Total Patients Enrolled
Peter LeWitt, M.D.Principal InvestigatorHenry Ford Health System
1 Previous Clinical Trials

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study to Assess the Clinical Benefit and Safety of Droxidopa in Parkinson's Disease
Peter LeWitt MD 2015. "Study to Assess the Clinical Benefit and Safety of Droxidopa in Parkinson's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02066571.
All > Parkinson
~2 spots leftby Apr 2025
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