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Safety and Efficacy of Droxidopa for Fatigue in Patients With Parkinsonism

NCT03446807 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2022-03-02

No results posted yet for this study

Summary

The purpose of this study is to determine the efficacy of Droxidopa for the treatment of fatigue in patients with Parkinsonism by the Visual Analog Fatigue Scale (VAFS). This is a randomized, placebo-controlled, double-blind clinical trial for 3 months where half the subjects will receive placebo and the other half will receive Droxidopa. Following this will be a wash-out period of 7 days and then all subjects will receive Droxidopa for 3 months during the open-label phase.

Conditions

Interventions

DRUG

Droxidopa

Droxidopa in 100, 200, and 300mg capsules. Maximum dose to be used in this study is 600mg.

DRUG

Placebo Oral Tablet

Placebo capsules to match Droxidopa 100, 200, and 300mg capsules.

Sponsors & Collaborators

  • H. Lundbeck A/S

    collaborator INDUSTRY

  • Loma Linda University

    lead OTHER

Principal Investigators

  • Khashayar Dashtipour, M.D. Ph.D. · Loma Linda University Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-31
Primary Completion
2023-07-01
Completion
2023-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT03446807 on ClinicalTrials.gov