Fibromyalgia MedDRA version: 20.0 Level: PT Classification code 10048439 Term: Fibromyalgia System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Trade Name: Naltrexone
Pharmaceutical Form: Tablet
INN or Proposed INN: Naltrexone hydrochloride
Other descriptive name: NALTREXONE HYDROCHLORIDE
Concentration unit: mg milligram(s)
Concentration type
Sponsors
Odense University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Women aged 18-64 years - Understands and writes Danish - Fulfills the ACR1990 criteria for fibromyalgia - A minimum score of 4 in self-reported average pain during the last 7 days on a 0-10 NRS at baseline - All fertile women have to use safe anti conception Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: - 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 up to 4 weeks before inclusion in the trial - Abuse of alcohol or other substances - Inflammatory rheumatic diseases - Demyelinating diseases - Active cancer - Liver dysfunction (ALAT must not be elevated more than 2-fold over highest reference level) - Kidney dysfunction (GFR < 59 mL/min) - Psychotic diseases - History of suicide attempts - Suicide ideation – evaluated using PHQ-9 (Item 9 has to be answered “never”)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the trial is to investigate whether treatment with Low dose Naltrexone (LDN) has a superior effect compared with placebo on pain in female patients with fibromyalgia, evaluated after 12 weeks of treatment.;Secondary Objective: Our key secondary efficacy objectives will be to compare the effect of drug LDN, relative to placebo, on (i) global assessment and on (ii) changes in pain, (iii) tenderness, (iv) fatigue, (v) sleep disturbance, (vi) depression, (vii) anxiety, (viii) cognition, (ix) stiffness, (x) physical function, (xi) quality of life and (xii) pain distribution from baseline to week 4, 8 and 12, in female patients with fibromyalgia. Furthermore, responder indices will be compared between the treatment groups. Among the exploratory secondary objectives are changes in muscle exhaustion, physical fitness, pain sensitivity, inhibition of pain, augmentation of pain, and pro- or anti-inflammatory cytokines. ;Primary end point(s): Average pain during the last 7 days. 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. ;Timepoint(s) of evaluation of this end point: After 12 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary outcomes include 21 supportive measures that will be collected, analyzed and reported in the primary manuscript. For the following secondary outcomes, the between-group change at baseline compared to 4, 8 and 12 weeks of treatment is assessed: 1. Global assessment. Assessed by Patient Global Impression of Change on a 1-7 Verbal Rating Scale. 2. Impact of fibromyalgia. Assessed by the FIQR total score (22). 3. Pain distribution. Assessed by the Widespread Pain Index (WPI) from the 2016 diagnostic criteria for fibromyalgia (23). 4. Level of pain (assessment of pain intensity trajectory). Assessed by the FIQR "level of pain" question. 5. Level of tenderness. Assessed subjectively by the FIQR "level of tenderness to touch" question and assessed objectively by measurement of pressure pain threshold, using a handheld algometer. 6. Level of fatigue. Assessed by the FIQR "level of energy" question. 7. Level of sleep disturbance. Assessed by the FIQR "quality of sleep" question. 8. Level of depression. Assessed by the FIQR "level of depression" question. 9. Level of anxiety. Assessed by the FIQR "level of anxiety" question. 10. Level of cognition. Assessed by the FIQR "level of memory problems" question. 11. Level of stiffness. Assessed by the FIQR "level of stiffness" question. 12. Level of physical function. Assessed by the physical function domain of FIQR. 13. Health-related quality of life – mobility. Assessed by the European Quality of Life 5 Dimensions (EQ-5D) mobility domain. 14. Health-related quality of life - self-care. Assessed by the EQ-5D self-care domain. 15. Health-related quality of life - usual activities. Assessed by the EQ-5D usual activities domain. 16. Health-related quality of life - pain/discomfort. Assessed by the EQ-5D pain/discomfort domain. 17. Health-related quality of life - anxiety/depression. Assessed by the EQ-5D anxiety/depression domain. 18. Health-related quality of life – global. Assessed | — |
Countries
Denmark
Contacts
Public ContactPain centre
Odense University Hospital
Outcome results
None listed