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Brain Perfusion & Oxygenation in Parkinson's Disease With NOH

NCT03229174 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2022-09-06

No results posted yet for this study

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.

Conditions

  • Parkinson Disease
  • Neurogenic Orthostatic Hypotension

Interventions

DRUG

Droxidopa

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

DRUG

Placebo

Placebo (sugar pill)

Sponsors & Collaborators

  • Lundbeck LLC

    collaborator INDUSTRY

  • William Ondo, MD

    lead OTHER

Principal Investigators

  • William Ondo, MD · The Methodist Hospital Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-23
Primary Completion
2022-02-02
Completion
2022-02-02
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03229174 on ClinicalTrials.gov