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NCT03674541 · ClinicalTrials.gov registry record · Phase 2
The Exercise Response to Pharmacologic Cholinergic Stimulation in Myalgic Encephalomyelitis / Chronic Fatigue Syndrome
A Phase 2 study of Fibromyalgia and Orthostatic Hypotension, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
- 1
- Study location
NCT03674541 is a Phase 2 study of Fibromyalgia and Orthostatic Hypotension that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 45 participants, below the 179-participant average among 76 other Fibromyalgia trials with a reported enrollment target (75% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03674541, a Phase 2 study of Fibromyalgia and Orthostatic Hypotension, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 45 participants
- Enrollment target
- 1
- Study location
Study Summary
Myalgic encephalomyelitis/Chronic fatigue syndrome (ME/CFS), otherwise known as Chronic fatigue syndrome (CFS) or myalgic encephalomyelitis (ME), is an under-recognized disorder whose cause is not yet understood. Suggested theories behind the pathophysiology of this condition include autoimmune causes, an inciting viral illness, and a dysfunctional autonomic nervous system caused by a small fiber polyneuropathy. Symptoms include fatigue, cognitive impairments, gastrointestinal changes, exertional dyspnea, and post-exertional malaise. The latter two symptoms are caused in part by abnormal cardiopulmonary hemodynamics during exercise thought to be due to a small fiber polyneuropathy. This manifests as low biventricular filling pressures throughout exercise seen in patients undergoing an invasive cardiopulmonary exercise test (iCPET) along with small nerve fiber atrophy seen on skin biopsy. After diagnosis, patients are often treated with pyridostigmine (off-label use of this medication) to enhance cholinergic stimulation of norepinephrine release at the post-ganglionic synapse. This is thought to improve venoconstriction at the site of exercising muscles, leading to improved return of blood to the heart and increasing filling of the heart to more appropriate levels during peak exercise. Retrospective studies have shown that noninvasive measurements of exercise capacity, such as oxygen uptake, end-tidal carbon dioxide, and ventilatory efficiency, improve after treatment with pyridostigmine. To date, there are no studies that assess invasive hemodynamics after pyridostigmine administration. It is estimated that four million people suffer from ME/CFS worldwide, a number that is thought to be a gross underestimate of disease prevalence. However, despite its potential for debilitating symptoms, loss of productivity, and worldwide burden, the pathophysiology behind ME/CFS remains unknown and its treatment unclear. By evaluating the exercise response to cholinergic stimula
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Pyridostigmine Bromide
Study Locations (1)
Massachusetts
- Brigham and Women's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2020-01-14 |
| Est. Completion | 2021-12-20 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03674541
The ClinicalTrials.gov registry entry for NCT03674541 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 179-participant average among 76 other Fibromyalgia trials with a reported enrollment target (75% lower). The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
The record links to 9 conditions, with Fibromyalgia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03674541 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03674541 about?
NCT03674541 is a clinical study titled "The Exercise Response to Pharmacologic Cholinergic Stimulation in Myalgic Encephalomyelitis / Chronic Fatigue Syndrome". Myalgic encephalomyelitis/Chronic fatigue syndrome (ME/CFS), otherwise known as Chronic fatigue syndrome (CFS) or myalgic encephalomyelitis (ME), is an under-recognized disorder whose cause is not yet understood. Suggested theories behind the pathophysiology of this condition include autoimmune caus...
What is the current status of trial NCT03674541?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2020-01-14. Estimated completion is 2021-12-20.
What conditions does trial NCT03674541 study?
This clinical trial studies the following conditions: Fibromyalgia, Orthostatic Hypotension, Chronic Fatigue Syndrome, Postural Orthostatic Tachycardia Syndrome, Dysautonomia.
What interventions are being tested in trial NCT03674541?
The interventions under investigation include: Placebo (DRUG), Pyridostigmine Bromide (DRUG).
Who is sponsoring clinical trial NCT03674541?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03674541 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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