Study to Assess the Clinical Benefit and Safety of Droxidopa in Parkinson's Disease
A Phase II, Double-Blind, Placebo-Controlled, Crossover Study to Assess Clinical Benefit and Safety of Droxidopa in the Treatment of Parkinson's Disease
2 other identifiers
interventional
20
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2015
Typical duration for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 18, 2014
CompletedFirst Posted
Study publicly available on registry
February 19, 2014
CompletedStudy Start
First participant enrolled
March 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedNovember 3, 2016
November 1, 2016
2.1 years
February 18, 2014
November 2, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
4 weeks
Secondary Outcomes (4)
Change in measurement of freezing of gait
4 weeks
Change in the incidence of falls
4 weeks
Change in signs and symptoms of Parkinson's disease
4 weeks
Number of participants with serious and non-serious adverse events
up to 11 weeks
Study Arms (2)
droxidopa, then sugar pill
OTHERDroxidopa 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.
sugar pill, then droxidopa
OTHERSubject 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Provide written informed consent to participate in the study
- Diagnosed with probable levodopa-responsive idiopathic PD (meeting United Kingdom PD Brain Bank diagnostic criteria), and receiving levodopa therapy for this disorder. Other PD medications can also be used.
- Must have AT LEAST ONE of below two criteria:
- At least 3 months incidence of typical freezing of gait symptoms, occurring while levodopa is otherwise providing an "on" mobility state (including at least one of the following Freezing of Gait patterns: start hesitancy, freezing at making turns or when passing through a doorway, spontaneous freezing during continued walking, or Freezing of Gait related to a simultaneous mental or physical activity) OR
- Have a screening score between 22 and 26 (inclusive) on the Montreal Cognitive Assessment
You may not qualify if:
- Taking direct acting vasoconstriction agent (i.e. ephedrine or midodrine). Subjects taking vasoconstrictor agents such as ephedrine or midodrine must stop taking these drugs at least 2 days or 5 half-lives (whichever is longer) prior to their baseline visit
- Taking anti-hypertensive medication for the treatment of hypertension. Anti-hypertensive medication taken at night to prevent supine hypertension will be allowed
- Changing dose or frequency of PD medication within 2 weeks of baseline
- Use of cognitive-enhancing medications (donepezil, galantamine, rivastigmine, tacrine, or memantine), catechol-O-methyltransferase inhibitors (tolcapone or entacapone), anticholinergic drugs, or antipsychotic drugs (including quetiapine or clozapine).
- Known or suspected alcohol or substance abuse within 1 year (e.g. DSM-IV definition of alcoholism)
- Past or current history of chronic severe hypertension (with repeated findings of BP 150/90 mmHg in the supine or standing position)
- Symptomatic coronary artery disease, severe congestive heart failure (NYHA Class 3 or 4)
- Unable to remain off any effective Freezing of Gait medications for 12 hrs prior to Evaluation visits)
- Women who are pregnant, lactating, or plan to become pregnant during the course of this study
- Women of child bearing potential who are not using two methods of contraception (at least one barrier, i.e. condom) with their partner.
- Male subjects who are sexually active with a woman of child bearing potential and not using two methods of contraception (at least one barrier, for example, condom)
- A history of closed angle glaucoma;
- Active (in the last 6 months) atrial fibrillation or, in the investigator's opinion, any other significant cardiac arrhythmia that should preclude the subject from this trial
- History of myocardial infarction or unstable angina
- Congestive heart failure (NYHA Class 3 or 4)
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Rush University Medical Center
Chicago, Illinois, 60612, United States
Henry Ford Hospital, West Bloomfield
West Bloomfield, Michigan, 48322, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter LeWitt, M.D.
Henry Ford Health System
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D.
Study Record Dates
First Submitted
February 18, 2014
First Posted
February 19, 2014
Study Start
March 1, 2015
Primary Completion
April 1, 2017
Study Completion
December 1, 2017
Last Updated
November 3, 2016
Record last verified: 2016-11