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NCT00977171 · ClinicalTrials.gov registry record · Phase 2
Study To Assess The Clinical Benefit Of Droxidopa In Subjects With Chronic Fatigue Syndrome
A Phase 2 study, sponsored by Chelsea Therapeutics.
- Terminated
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT00977171 is a Phase 2 study that was terminated before completion, run by Chelsea Therapeutics. The registered enrollment target is 3 participants.
The verdict
NCT00977171, a Phase 2 study, was terminated before completion, sponsored by Chelsea Therapeutics.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study 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.
Interventions
- DRUG Droxidopa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2010-07 |
| Est. Completion | 2011-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00977171
The ClinicalTrials.gov registry entry for NCT00977171 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Chelsea Therapeutics, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Droxidopa is the first listed.
NCT00977171 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00977171 about?
NCT00977171 is a clinical study titled "Study To Assess The Clinical Benefit Of Droxidopa In Subjects With Chronic Fatigue Syndrome". 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 pati...
What is the current status of trial NCT00977171?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2010-07. Estimated completion is 2011-10.
What interventions are being tested in trial NCT00977171?
The interventions under investigation include: Droxidopa (DRUG).
Who is sponsoring clinical trial NCT00977171?
This trial is sponsored by Chelsea Therapeutics, which has 10 total clinical trials registered on ClinicalTrials.gov.
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