drugset / Trial / NCT04270877
Fibromyalgia and Naltrexone: The FINAL Study
Phase 2
Completed
99 enrolled
Odense University Hospital
University Hospital Bispebjerg and Frederiksberg · collabUniversity of Southern Denmark · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study evaluates the effect of low dose naltrexone (LDN) on pain in women with fibromyalgia (FM). The study is designed as a parallel randomized (1:1) double blind, placebo-controlled superiority trial. Half of the participants will receive treatment with LDN while the other half will receive treatment with placebo.
Timeline
- Start
- 2021-01-06
- Primary completion
- 2022-12-27
- Completion
- 2022-12-27
Outcome
Missed primary endpoint
paper This study did not show that treatment with low-dose naltrexone was superior to placebo in relieving pain. PMID 38258677 ↗
Publications
- Due Bruun K, Christensen R, Amris K, Vaegter HB, Blichfeldt-Eckhardt MR, Bye-Moller L, Holsgaard-Larsen A, Toft P. Naltrexone 6 mg once daily versus placebo in women with fibromyalgia: a randomised, double-blind, placebo-controlled trial. Lancet Rheumatol. 2024 Jan;6(1):e31-e39. doi: 10.1016/S2665-9913(23)00278-3. Epub 2023 Dec 5.
- Bruun KD, Amris K, Vaegter HB, Blichfeldt-Eckhardt MR, Holsgaard-Larsen A, Christensen R, Toft P. Low-dose naltrexone for the treatment of fibromyalgia: protocol for a double-blind, randomized, placebo-controlled trial. Trials. 2021 Nov 15;22(1):804. doi: 10.1186/s13063-021-05776-7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Naltrexone | Small molecule | 6 mg | Oral |