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NCT03582085
Phase II Clinical Trial: Multi-dosing the BCG Vaccine for Fibromyalgia
Phase 2 trial testing Bacillus Calmette Guerin Vaccine in Fibromyalgia. Withdrawn.
1 January 2027
Quick facts
| Lead sponsor | Massachusetts General Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Start date | 1 January 2026 |
| Primary completion | 1 January 2027 |
| Estimated completion | 1 January 2027 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Bacillus Calmette Guerin Vaccine — full drug profile →
- Saline Injection
Conditions studied
- Fibromyalgia — all drugs for Fibromyalgia →
Sponsor
Massachusetts General Hospital
Who can join
Adults 18 to 65, any sex, with Fibromyalgia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The investigators are doing this research study to explore whether the bacillus Calmette-Guérin (BCG) vaccine can be an effective treatment for fibromyalgia. The researchers believe that the BCG vaccine can benefit people with fibromyalgia by increasing immune signaling molecules, called cytokines. The Faustman Immunobiology Laboratory has previously studied BCG in long term type 1 diabetics, and found that BCG vaccinations showed a short and small pancreas effect of restored insulin secretion. Eligible volunteers will be vaccinated with BCG in repeat fashion over a period of three years or receive placebo treatment. The investigators hypothesize that these repeat injections of BCG will reduce symptom severity by increasing immune signaling cytokines.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03582085
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Massachusetts General Hospital trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03582085 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Massachusetts General Hospital
- Last refreshed: 21 November 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03582085.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing