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Study to Assess the Clinical Benefit and Safety of Droxidopa in Parkinson's Disease

NCT ID: NCT02066571

Last Updated: 2016-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Parkinson's Disease Freezing of Gait Cognitive Ability, General

Keywords

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Parkinson's disease Freezing of gait Gait

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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droxidopa, then sugar pill

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.

Group Type OTHER

Droxidopa

Intervention Type DRUG

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

Intervention Type 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.

sugar pill, then droxidopa

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 Type OTHER

Droxidopa

Intervention Type DRUG

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

Intervention Type 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.

Interventions

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Droxidopa

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.

Intervention Type DRUG

sugar pill

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.

Intervention Type DRUG

Other Intervention Names

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placebo

Eligibility Criteria

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Inclusion Criteria

* 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:

1. 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
2. Have a screening score between 22 and 26 (inclusive) on the Montreal Cognitive Assessment

Exclusion Criteria

* 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)
* Diabetes insipidus, insulin-dependent diabetes mellitus, or diabetic neuropathy
* In the investigator's opinion, any other significant systemic illness
* Known or suspected malignancy (other than basal cell carcinoma)
* Known gastrointestinal illness or other gastrointestinal disorder that may, in the investigator's opinion, affect the absorption of study drug
* Any major surgical procedure within 30 days of the baseline visit
* Currently receiving any investigational drug or have received an investigational drug within 30 days of the baseline visit
* In the investigator's opinion, clinically significant abnormalities on clinical examination or laboratory testing that should preclude the subject from this trial.
* Findings from suicidality screening that are compatible with risk for suicide
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Henry Ford Health System

OTHER

Sponsor Role lead

Responsible Party

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Peter LeWitt MD

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter LeWitt, M.D.

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Health System

Locations

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Rush University Medical Center

Chicago, Illinois, United States

Site Status

Henry Ford Hospital, West Bloomfield

West Bloomfield, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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IND 119340

Identifier Type: OTHER

Identifier Source: secondary_id

LeWitt01

Identifier Type: -

Identifier Source: org_study_id