Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
99 participants
INTERVENTIONAL
2021-01-06
2022-12-27
Brief Summary
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Detailed Description
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LDN has antagonistic effect on both opioid receptors and on toll-like receptors in glia cells. Mediated via those receptors, LDN can potentially reduce neuroinflammation and induce homeostasis in the endorphin system in patients with fibromyalgia.
The aim of the trial is to investigate whether treatment with LDN has a superior effect compared to placebo on pain among female patients with fibromyalgia, evaluated after 12 weeks of treatment. The study is also exploring secondary aims regarding a possible improvement of other fibromyalgia core symptoms and a possible improvement of global assessment, daily functioning and health-related quality of life. Among the exploratory secondary objectives are changes in muscle exhaustion, physical fitness, pain sensitivity, inhibition of pain, augmentation of pain, and pro-inflammatory cytokines.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Naltrexone
Low Dose Naltrexone (LDN) is administered for 12 weeks, including a titration phase of 4 weeks.
Participants will be titrated up to 6 mg following a dose escalation scheme: Initial dosage of 1.5 mg daily, escalated every seventh day by 1.5 mg up to 6 mg at week 4. Dose escalation will be based on safety and tolerability, and if dose escalation is not feasible, delayed increments are allowed. After end of titration (week 4) the subjects will be maintained at the highest tolerated dose level for the last 8 weeks of the treatment period. Subjects are not allowed to change dose during the last 8 weeks of the treatment period.
The medicine is taken orally as tablets once daily in the evening.
Naltrexone Pill
Treatment with LDN for 12 weeks, including af titration phase of 4 weeks. Initial dosage of 1.5 mg, dose is increased by 1.5 mg every 7th day to 6 mg at week 4. Dosing is increased based on safety and tolerability and delayed increments are allowed. The participants are maintained on the highest tolerable dose for the last 8 weeks of the treatment period.
Placebo
LDN-placebo is administered for 12 weeks, including a titration phase of 4 weeks.
Participants will be titrated up to 6 mg following a dose escalation scheme: Initial dosage of 1.5 mg daily, escalated every seventh day by 1.5 mg up to 6 mg at week 4. Dose escalation will be based on safety and tolerability, and if dose escalation is not feasible, delayed increments are allowed. After end of titration (week 4) the subjects will be maintained at the highest tolerated dose level for the last 8 weeks of the treatment period. Subjects are not allowed to change dose during the last 8 weeks of the treatment period.
The medicine is taken orally as tablets (similar in size, shape and taste to the active medication), once daily in the evening.
Placebo oral tablet
Treatment with LDN-placebo for 12 weeks, including af titration phase of 4 weeks. Initial dosage of 1.5 mg, dose is increased by 1.5 mg every 7th day to 6 mg at week 4. Dosing is increased based on safety and tolerability and delayed increments are allowed. The participants are maintained on the highest tolerable dose for the last 8 weeks of the treatment period.
Interventions
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Naltrexone Pill
Treatment with LDN for 12 weeks, including af titration phase of 4 weeks. Initial dosage of 1.5 mg, dose is increased by 1.5 mg every 7th day to 6 mg at week 4. Dosing is increased based on safety and tolerability and delayed increments are allowed. The participants are maintained on the highest tolerable dose for the last 8 weeks of the treatment period.
Placebo oral tablet
Treatment with LDN-placebo for 12 weeks, including af titration phase of 4 weeks. Initial dosage of 1.5 mg, dose is increased by 1.5 mg every 7th day to 6 mg at week 4. Dosing is increased based on safety and tolerability and delayed increments are allowed. The participants are maintained on the highest tolerable dose for the last 8 weeks of the treatment period.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Understands and writes Danish
* Fulfills the American College of Rheumatology 1990 criteria for fibromyalgia
* A minimum score of 4 in self-reported average pain during the last 7 days on a 0-10 numeric rating scale at baseline
* All fertile women have to use safe anti conception (Spiral, birth control pills, contraceptive patch, contraceptive vaginal ring or gestagen injections) for 3 weeks before and 1 week after the trial. If the patients' normal lifestyle includes sexual abstinence, they do not have to use anti conception. Instead they can give an oral informed consent, that they will be sexually abstinent during the trial. A woman is considered non-fertile if she is sterilized, hysterectomized, bilateral oophorectomized or is postmenopausal. A woman is considered postmenopausal when vaginal bleeding has been absent for 1 year and is confirmed by measurement of follicle-stimulating hormone.
Exclusion Criteria
* Pregnancy or breastfeeding. A negative pregnancy test has to be available for all fertile subjects at baseline
* Use of opioids or NSAIDs during the 4 weeks before inclusion in the trial
* Abuse of alcohol or other substances
* Inflammatory rheumatic diseases
* Demyelinating diseases
* Active cancer
* Liver dysfunction
* Kidney dysfunction
* Psychotic diseases
* History of suicide attempts
* Suicide ideation - evaluated using Patient Health Questionnaire-9 (Item 9 has to be answered "never")
18 Years
64 Years
FEMALE
No
Sponsors
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University of Southern Denmark
OTHER
University Hospital Bispebjerg and Frederiksberg
OTHER
Odense University Hospital
OTHER
Responsible Party
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Karin Bruun Plesner
Principal Investigator
Principal Investigators
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Karin D Bruun, Consultant
Role: PRINCIPAL_INVESTIGATOR
Odense University Hospital
Locations
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Pain centre, Odense University Hospital
Odense, , Denmark
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2019-000702-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
R177-A6158
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
A3650
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
21-10-0037
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
18021
Identifier Type: -
Identifier Source: org_study_id