FibromyalgiaPhase 2FINALNCT04270877
Fibromyalgia and Naltrexone: The FINAL Study
A Phase 2 study testing Naltrexone Pill in people with Fibromyalgia, run by Odense University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Naltrexone Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 1 siteDenmark
- Study dates
- 6 Jan 2021to 27 Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 18-64 years
- 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.
Who cannot join
- Known allergy against naltrexonehydroclorid
- 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
Show all 12Show fewer
- 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")
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Low dose naltrexone (LDN) is used widely as off label treatment in patients with fibromyalgia, despite the lack of larger randomized controlled trials (RCT) supporting an effect.
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
- Fibromyalgia
- Being tested
- Naltrexone Pill, Placebo oral tablet
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naltrexone PillDrug
Also called LDN
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 tabletDrug
Also called LDN-placebo
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.
| Study group | Role | What they receive |
|---|---|---|
| Naltrexone | Experimental | 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. Receives: Drug: Naltrexone Pill |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average pain during the last 7 days
Assessed by asking the participants about the level of average pain during the last 7 days on a 11 point rating scale, ranging from 0-10 (0 = "no pain" and 10 = "unbearable pain") using the first item from the symptom part of the Fibromyalgia Impact Questionnaire Revised. A lower score indicates lower severity.
Measured: Change from baseline when assessed after 12 weeks of treatment with LDN or LDN-placebo
Secondary outcomes (21)
Global assessment
Measured by Patient Global Impression of Change on a 1-7 Verbal Rating Scale. The participants are asked how they rate their overall fibromyalgia symptoms after 4, 8 and 12 weeks of treatment compared with before treatment. A score of 4 indicates "no change", a score of 1 is characterized by "a lot worse" and a score of 7 is characterized by "a lot better." A higher score indicates higher degree of improvement.
Measured: Change in overall fibromyalgia symptoms from baseline when assessed after 4, 8, and 12 weeks of treatment with LDN or LDN-placebo
Impact of fibromyalgia
Measured by the Fibromyalgia Impact Questionnaire Revised (FIQR) total score. The FIQR asks patients to rate how difficult it is to perform a list of 9 common activities over the previous 7 days on an 11 point scale, ranging from 0-10 (0 = "no difficulty" and 10 = "very difficult"). The FIQR then asks patients to indicate how often their fibromyalgia impacts their quality of life over the last 7 days on an 11 point scale, ranging from 1-10 (0 = "never" and 10 = "always"). Finally, the FIQR asks patients to assess the severity of 10 different symptoms on an 11 point scale, ranging from 0-10 (0 = "no symptoms" and 10 = "extreme symptoms"). These three sub-scales are summed to represent an overall FIQR score. A lower score indicates lower severity.
Measured: Change from baseline when assessed after 4, 8, and 12 weeks of treatment with LDN or LDN-placebo
Pain distribution
Assessed by the Widespread Pain Index (WPI) from The American College of Rheumatology 2016 revised criteria for fibromyalgia (ACR-2016). The body is divided into 19 body parts and number of pain full body parts during the last 7 days is counted, giving rise to the WPI. A lower score indicates lower spreading of pain.
Measured: Change from baseline when assessed after 4, 8, and 12 weeks of treatment with LDN or LDN-placebo
Level of pain
Assessed by the Fibromyalgia Impact Questionnaire Revised "level of pain" question, asking the participants to rate the average level of pain during the last 7 days on a 11 point rating scale, ranging from 0-10 (0 = "no pain" and 10 = "unbearable pain"). A lower score indicates lower severity.
Measured: Change from baseline when assessed after 4, 8, and 12 weeks of treatment with LDN or LDN-placebo
Level of tenderness
Assessed by the Fibromyalgia Impact Questionnaire Revised "level of tenderness to touch" question, asking the participants to rate the average level of tenderness to touch during the last 7 days on an 11 point rating scale, ranging from 0-10 (0 = "no tenderness" and 10 = "very tender"). A lower score indicates a lower severity.
AND
Assessed by measurement of pressure pain threshold, using a handheld algometer. Points measured: Right Quadriceps 15 cm proximal of apex patella and left Trapezius 10 cm from acromion. Each point is measured 3 times. Pressure pain threshold is measured in kilopascal (kPa). A higher value indicates a lower severity.
Measured: Change from baseline when assessed after 4, 8, and 12 weeks of treatment with LDN or LDN-placebo
Level of fatigue
Assessed by the Fibromyalgia Impact Questionnaire Revised "level of energy" question, asking the participants to rate the average level of energy during the last 7 days on an 11 point rating scale, ranging from 0-10 (0 = "lots of energy" and 10 = "no energy"). A lower score indicates a lower severity.
Measured: Change from baseline when assessed after 4, 8, and 12 weeks of treatment with LDN or LDN-placebo
Level of sleep disturbance
Assessed by the Fibromyalgia Impact Questionnaire Revised "quality of sleep" question asking the participants to rate the average quality of sleep during the last 7 days on an 11 point rating scale, ranging from 0-10 (0 = "awoke well rested" and 10 = "awoke very tired"). A lower score indicates a lower severity.
Measured: Change from baseline when assessed after 4, 8, and 12 weeks of treatment with LDN or LDN-placebo
Level of depression
Assessed by the Fibromyalgia Impact Questionnaire Revised "level of depression" question, asking the participants to rate the average level of depression during the last 7 days on an 11 point rating scale, ranging from 0-10 (0 = "no depression" and 10 = "very depressed"). A lower score indicates a lower severity.
Measured: Change from baseline when assessed after 4, 8, and 12 weeks of treatment with LDN or LDN-placebo
Level of anxiety
Assessed by the Fibromyalgia Impact Questionnaire Revised "level of anxiety" question, asking the participants to rate the average level of anxiety during the last 7 days on an 11 point rating scale, ranging from 0-10 (0 = "not anxious" and 10 = "very anxious"). A lower score indicates a lower severity.
Measured: Change from baseline when assessed after 4, 8, and 12 weeks of treatment with LDN or LDN-placebo
Level of cognition
Assessed by the Fibromyalgia Impact Questionnaire Revised "level of memory problems" question, asking the participants to rate the average level of memory problems during the last 7 days on an 11 point rating scale, ranging from 0-10 (0 = "good memory" and 10 = "very poor memory"). A lower score indicates a lower severity.
Measured: Change from baseline when assessed after 4, 8, and 12 weeks of treatment with LDN or LDN-placebo
Level of stiffness
Assessed by the Fibromyalgia Impact Questionnaire Revised "level of stiffness" question, asking the participants to rate the average level of stiffness during the last 7 days on an 11 point rating scale, ranging from 0-10 (0 = "no stiffness" and 10 = "severe stiffness"). A lower score indicates a lower severity.
Measured: Change from baseline when assessed after 4, 8, and 12 weeks of treatment with LDN or LDN-placebo
Level of physical function
Assessed by the physical function domain of Fibromyalgia Impact Questionnaire Revised; asking participants to rate how difficult it is to perform a list of 9 common activities over the previous 7 days on an 11 point scale, ranging from 0-10 (0 = "no difficulty" and 10 = "very difficult"). The score is characterized by the sum of the 9 scores (0-90). A lower score indicates better function.
Measured: Change from baseline when assessed after 4, 8, and 12 weeks of treatment with LDN or LDN-placebo
Health-related quality of life - mobility
Measured by the European Quality of Life 5 Dimensions (EQ-5D) mobility domain; asking the participants to rate their mobility on a 1-5 Verbal Rating Scale, a score of 1 indicating no problems, and a score of 5 indicating extreme problems. A lower score indicates a lower severity.
Measured: Change from baseline when assessed after 4, 8, and 12 weeks of treatment with LDN or LDN-placebo
Health-related quality of life - self care
Measured by the European Quality of Life 5 Dimensions (EQ-5D) self care domain; asking the participants to rate their ability for self care on a 1-5 Verbal Rating Scale, a score of 1 indicating no problems, and a score of 5 indicating extreme problems. A lower score indicates a lower severity.
Measured: Change from baseline when assessed after 4, 8, and 12 weeks of treatment with LDN or LDN-placebo
Health-related quality of life - usual activities
Measured by the European Quality of Life 5 Dimensions (EQ-5D) usual activities domain; asking the participants to rate their ability to perform usual activities on a 1-5 Verbal Rating Scale, a score of 1 indicating no problems, and a score of 5 indicating extreme problems. A lower score indicates a lower severity.
Measured: Change from baseline when assessed after 4, 8, and 12 weeks of treatment with LDN or LDN-placebo
Health-related quality of life - pain/discomfort
Measured by the European Quality of Life 5 Dimensions (EQ-5D) pain/discomfort domain; asking the participants to rate their level of pain or discomfort on a 1-5 Verbal Rating Scale, a score of 1 indicating no problems, and a score of 5 indicating extreme problems. A lower score indicates a lower severity.
Measured: Change from baseline when assessed after 4, 8, and 12 weeks of treatment with LDN or LDN-placebo
Health-related quality of life - anxiety/depression
Measured by the European Quality of Life 5 Dimensions (EQ-5D) anxiety/depression domain; asking the participants to rate their level of anxiety or depression on a 1-5 Verbal Rating Scale, a score of 1 indicating no problems, and a score of 5 indicating extreme problems. A lower score indicates a lower severity.
Measured: Change from baseline when assessed after 4, 8, and 12 weeks of treatment with LDN or LDN-placebo
Health-related quality of life - global
Measured by European Quality of Life Visual Analogue Scale (EQ-VAS), which asks the participant to rate their overall health 'today' on a 0-100 VAS. A higher score indicates a better quality of life.
Measured: Change from baseline when assessed after 4, 8, and 12 weeks of treatment with LDN or LDN-placebo
Number of responders with a more than 15% improvement of pain
A responder is defined as a subject who reports a more than 15% improvement of the primary outcome (average pain during the last 7 days) after 12 weeks of treatment with LDN or LDN-placebo. Number of responders are calculated for both the LDN group and the LDN-placebo group.
Measured: Number of responders after 12 weeks of treatment with LDN or LDN placebo
Number of responders with a more than 30% improvement of pain
A responder is defined as a subject who reports a more than 30% improvement of the primary outcome (average pain during the last 7 days) after 12 weeks of treatment with LDN or LDN-placebo. Number of responders are calculated for both the LDN group and the LDN-placebo group.
Measured: Number of responders after 12 weeks of treatment with LDN or LDN placebo
Number of responders with a more than 50% improvement of pain
A responder is defined as a subject who reports a more than 50% improvement of the primary outcome (average pain during the last 7 days) after 12 weeks of treatment with LDN or LDN-placebo. Number of responders are calculated for both the LDN group and the LDN-placebo group.
Measured: Number of responders after 12 weeks of treatment with LDN or LDN placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start6 Jan 2021
- Primary completion27 Dec 2022
- Study completion27 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A parallel randomized (1:1) double blind, placebo-controlled superior trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark, University Hospital Bispebjerg and Frederiksberg
- Responsible party
- Principal investigator, Karin Bruun Plesner, Odense University Hospital
- Investigators
- Karin D Bruun, Consultant, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04270877
- Sponsor's protocol ID
- 18021
- Other IDs
- 2019-000702-30, R177-A6158, A3650, 21-10-0037, 2019
- Acronym
- FINAL
- Status last verified
- Dec 2022
- First submitted
- 30 Jan 2020
- Last updated
- 29 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 38258677Bruun 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.
PubMed 34781989
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fibromyalgia and Naltrexone: The FINAL Study
- ClinicalTrials.gov ID
- NCT04270877
- Acronym / sponsor ID
- FINAL / 18021
- Conditions
- Fibromyalgia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- University of Southern Denmark, University Hospital Bispebjerg and Frederiksberg
- Study start
- 6 Jan 2021 (actual)
- Primary completion
- 27 Dec 2022 (actual)
- Study completion
- 27 Dec 2022 (actual)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Low dose naltrexone (LDN) is used widely as off label treatment in patients with fibromyalgia, despite the lack of larger randomized controlled trials (RCT) supporting an effect.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A parallel randomized (1:1) double blind, placebo-controlled superior trial
| Arm | Type | Receives |
|---|---|---|
| Naltrexone | Experimental | Drug: Naltrexone PillLow 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. |
| Placebo | Placebo comparator | Drug: Placebo oral tabletLDN-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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women aged 18-64 years
- 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.
Key exclusion criteria (12 listed)
- Known allergy against naltrexonehydroclorid
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Naltrexone PillAlso: LDNTreatment 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. | Drug | Naltrexone |
| Placebo oral tabletAlso: LDN-placeboTreatment 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. | Drug | Placebo |
Primary outcome
Average pain during the last 7 days
Time frame: Change from baseline when assessed after 12 weeks of treatment with LDN or LDN-placebo
Assessed by asking the participants about the level of average pain during the last 7 days on a 11 point rating scale, ranging from 0-10 (0 = "no pain" and 10 = "unbearable pain") using the first item from the symptom part of the Fibromyalgia Impact Questionnaire Revised. A lower score indicates lower severity.
21 secondary outcomes
Global assessment
Time frame: Change in overall fibromyalgia symptoms from baseline when assessed after 4, 8, and 12 weeks of treatment with LDN or LDN-placebo
Impact of fibromyalgia
Time frame: Change from baseline when assessed after 4, 8, and 12 weeks of treatment with LDN or LDN-placebo
Pain distribution
Time frame: Change from baseline when assessed after 4, 8, and 12 weeks of treatment with LDN or LDN-placebo
Level of pain
Time frame: Change from baseline when assessed after 4, 8, and 12 weeks of treatment with LDN or LDN-placebo
Level of tenderness
Time frame: Change from baseline when assessed after 4, 8, and 12 weeks of treatment with LDN or LDN-placebo
Level of fatigue
Time frame: Change from baseline when assessed after 4, 8, and 12 weeks of treatment with LDN or LDN-placebo
Level of sleep disturbance
Time frame: Change from baseline when assessed after 4, 8, and 12 weeks of treatment with LDN or LDN-placebo
Level of depression
Time frame: Change from baseline when assessed after 4, 8, and 12 weeks of treatment with LDN or LDN-placebo
Level of anxiety
Time frame: Change from baseline when assessed after 4, 8, and 12 weeks of treatment with LDN or LDN-placebo
Level of cognition
Time frame: Change from baseline when assessed after 4, 8, and 12 weeks of treatment with LDN or LDN-placebo
Level of stiffness
Time frame: Change from baseline when assessed after 4, 8, and 12 weeks of treatment with LDN or LDN-placebo
Level of physical function
Time frame: Change from baseline when assessed after 4, 8, and 12 weeks of treatment with LDN or LDN-placebo
Health-related quality of life - mobility
Time frame: Change from baseline when assessed after 4, 8, and 12 weeks of treatment with LDN or LDN-placebo
Health-related quality of life - self care
Time frame: Change from baseline when assessed after 4, 8, and 12 weeks of treatment with LDN or LDN-placebo
Health-related quality of life - usual activities
Time frame: Change from baseline when assessed after 4, 8, and 12 weeks of treatment with LDN or LDN-placebo
Health-related quality of life - pain/discomfort
Time frame: Change from baseline when assessed after 4, 8, and 12 weeks of treatment with LDN or LDN-placebo
Health-related quality of life - anxiety/depression
Time frame: Change from baseline when assessed after 4, 8, and 12 weeks of treatment with LDN or LDN-placebo
Health-related quality of life - global
Time frame: Change from baseline when assessed after 4, 8, and 12 weeks of treatment with LDN or LDN-placebo
Number of responders with a more than 15% improvement of pain
Time frame: Number of responders after 12 weeks of treatment with LDN or LDN placebo
Number of responders with a more than 30% improvement of pain
Time frame: Number of responders after 12 weeks of treatment with LDN or LDN placebo
Number of responders with a more than 50% improvement of pain
Time frame: Number of responders after 12 weeks of treatment with LDN or LDN placebo
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2022.
- Derived from this study: PubMed 38258677Due 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.
- Derived from this study: PubMed 34781989Bruun 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karin D Bruun, Consultant principal investigator
Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Naltrexone Pill in people with Fibromyalgia, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average pain during the last 7 days (time frame: Change from baseline when assessed after 12 weeks of treatment with LDN or LDN-placebo). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04270877, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2022.