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A Clinical Study of Patients With Symptomatic NOH to Assess Sustained Effects of Droxidopa Therapy

NCT01927055 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2016-01-08

Study results available
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Summary

Evaluate the clinical efficacy and safety of droxidopa versus placebo over a 17 week (maximum) treatment period in patients with symptomatic NOH.

Conditions

  • Symptomatic Neurogenic Orthostatic Hypotension
  • Parkinson's Disease
  • Multiple Systems Atrophy
  • Pure Autonomic Failure
  • Dopamine Beta Hydroxylase Deficiency

Interventions

DRUG

Droxidopa

Droxidopa at 100 mg, 200 mg, 300 mg

DRUG

Placebo

Placebo to match droxidopa capsules and strength designations

Sponsors & Collaborators

  • Chelsea Therapeutics

    lead INDUSTRY

Principal Investigators

  • Horacio Kaufmann, M.D. · NYU Langone Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT01927055 on ClinicalTrials.gov