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Study To Assess The Clinical Benefit Of Droxidopa In Subjects With Chronic Fatigue Syndrome

NCT00977171 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2014-06-09

Study results available
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Summary

A subset of patients suffering from chronic fatigue syndrome exhibit symptoms of neurally mediated hypotension. While the underlying pathophysiology of chronic fatigue syndrome is not precisely understood, a dysfunction of the autonomic nervous system is thought to play a role in this subset of patients. In several small studies, subjects within this subset have noted improvement in their chronic fatigue symptoms when treated for their neurally mediated hypotension. As droxidopa acts on the autonomic nervous system and has been shown to ameliorate symptoms of neurally mediated hypotension, it is hypothesized that droxidopa could aid in the treatment of chronic fatigue symptoms.

Neurally mediated hypotension has been associated with patients suffering from chronic fatigue syndrome. Droxidopa meanwhile has been approved in Japan for the treatment of the symptoms of neurogenic orthostatic hypotension. As such, it is hypothesized that regulating the autonomic nervous system in patients with Chronic fatigue syndrome may prove to be clinically beneficial.

Conditions

  • Chronic Fatigue Syndrome
  • Orthostatic Hypotension
  • Neurally Mediated Hypotension
  • Neurogenic Orthostatic Hypotension

Interventions

DRUG

Droxidopa

Oral, 100, 200, 300, 400, 500, or 600 mg TID, duration includes up to a 2 week titration period followed by a 12 week treatment period

Sponsors & Collaborators

  • Chelsea Therapeutics

    lead INDUSTRY

Principal Investigators

  • Charles W Lapp, M.D. · Hunter-Hopkins Center, P.A.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • United States

Study Locations

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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 NCT00977171 on ClinicalTrials.gov