Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Clinical Trial Phase 2 study, sponsored by Chelsea Therapeutics.
NCT00977171 is a Phase 2 study that was terminated before completion, run by Chelsea Therapeutics. The registered enrollment target is 3 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The CGI-I is a 7 point scale ranging from a score of 1 (very much improved) to 7 (very much worse), with no change in the middle, and assesses the improvement in relation to the baseline evaluation.
Interventions
- DRUG Droxidopa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2010-07 |
| Est. Completion | 2011-10 |
| Phase | Phase 2 |
Why NCT00977171 stopped before completion
NCT00977171 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Droxidopa is the first listed.
NCT00977171 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00977171's enrollment target sits among peer trials
3 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia