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Study to Assess the Clinical Benefit and Safety of Droxidopa in Parkinson's Disease | Clinical Trials | Clareo Health

UNKNOWNPHASE2

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

NCT02066571•Henry Ford Health System

View on ClinicalTrials.gov

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.

Eligibility

Age

30 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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.
+13 more criteria

Locations (2)

Rush University Medical Center

Chicago, Illinois, United States

Henry Ford Hospital, West Bloomfield

West Bloomfield, Michigan, United States

Key Dates

Start Date

March 1, 2015

Primary Completion Date

April 1, 2017

Completion Date

December 1, 2017

Last Updated

November 3, 2016

Enrollment

ESTIMATED participants

Conditions

Parkinson's DiseaseFreezing of GaitCognitive Ability, General

Interventions

Droxidopa

DRUG

sugar pill

DRUG

Deep Brain Stimulation Therapy in Movement Disorders

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Parkinson's Disease

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RECRUITINGPHASE1

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

NCT07310264

Healthy Volunteers (HV)Parkinson's Disease (PD)

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RECRUITINGNA

Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 3, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Deep Brain Stimulation Therapy in Movement Disorders

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study

A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease

Effect of Striatal Temporal Interference Stimulation on Language Processing in Neurodegenerative Diseases

SAD Study in Patients With Parkinson's Disease and Motor Fluctuations