NCT03229174

Brief Summary

This is a double blind placebo controlled trial in Parkinson's disease (PD) patients with neurogenic orthostatic hypotension (NOH). Investigators hypothesize that the study drug (droxidopa) may improve cerebral perfusion more robustly than systemic BP, possibly by direct action within the CNS vasculature. This study is designed to determine if droxidopa improves cerebral perfusion measures in PD patients with NOH, in addition to peripheral BP measures and subjective responses.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_4 parkinson-disease

Timeline
Completed

Started Aug 2018

Longer than P75 for phase_4 parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

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

April 21, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 25, 2017

Completed
1.1 years until next milestone

Study Start

First participant enrolled

August 23, 2018

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2022

Completed
Last Updated

September 6, 2022

Status Verified

September 1, 2022

Enrollment Period

3.4 years

First QC Date

April 21, 2017

Last Update Submit

September 1, 2022

Conditions

Parkinson DiseaseNeurogenic Orthostatic Hypotension

Outcome Measures

Primary Outcomes (2)

  • Cerebral perfusion

    Cerebral perfusion measured by trans-cranial ultrasound of middle cerebral artery "supine and standing" delta.

    8 weeks

  • Brain oxygenation

    Brain oxygenation as measured by cerebral pulse oximetry device, delta between supine and standing

    8 weeks

Secondary Outcomes (5)

  • Arteriole Blood Pressure

    8 weeks

  • R-R variability

    8 weeks

  • Orthostatic hypotension

    8 weeks

  • Assessment of Parkinson's disease symptoms

    8 weeks

  • Assessment of gait and falls

    8 weeks

Other Outcomes (5)

  • Assessment of depressive symptoms

    8 weeks

  • Assessment of sleepiness

    8 weeks

  • Assessment of cognitive changes

    8 weeks

  • +2 more other outcomes

Study Arms (2)

Intervention phase

EXPERIMENTAL

Droxidopa unforced titration dose (starting at 100mg by mouth TID) or matching placebo and titrated over 2 weeks up to maximum of 600 TID. Efficacy evaluation of given dose at week 4

Drug: DroxidopaDrug: Placebo

Open label extension phase

OTHER

All subjects allowed into a 4 week open label extension. Similar titration will start at 100mg Droxidopa three times a day (TID), but can be titrated up daily using the same dose escalation scale.

Drug: Droxidopa

Interventions

DroxidopaDRUG

Droxidopa initial dose 100mg TID, titrated in increments of 100mg every 24-48 hours to symptomatic response.

Also known as: Northera
Intervention phaseOpen label extension phase
PlaceboDRUG

Placebo (sugar pill)

Also known as: Sugar pill
Intervention phase

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Age \>85
  • Concurrent use of Midodrine
  • Medical conditions that in the opinion of the investigator, might not allow for same completion of the study i.e. unstable angina, neoplasm, etc

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

DroxidopaSugars

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

NorepinephrineCatecholaminesAminesOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSerineAmino Acids, NeutralAmino AcidsAmino Acids, Peptides, and ProteinsCarbohydrates

Study Officials

  • William Ondo, MD

    The Methodist Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 21, 2017

First Posted

July 25, 2017

Study Start

August 23, 2018

Primary Completion

February 2, 2022

Study Completion

February 2, 2022

Last Updated

September 6, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)