Investigation of dose response relationships when using low dose naltrexone (LDN) for the treatment of fibromyalgia

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002081-31-DK

Enrollment

Registered

2016-10-06

Start date

2016-11-17

Completion date

Unknown

Last updated

2018-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia MedDRA version: 20.0 Level: LLT Classification code 10016631 Term: Fibromyalgia syndrome System Organ Class: 100000004859

Interventions

Product Name: Naltrexon Pharmaceutical Form: Capsule INN or Proposed INN: NALTREXONE CAS Number: 16590-41-3 Concentration unit: mg milligram(s) Concentration type: up to Concentration number: 6-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Diagnosed with fibromyalgia by a rheumatologist Fullfils ACR 1990 og 2010 criteria for fibromyalgia Female Age 18-60 Use of anti conception Kaukasian Speaks and writes danish 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 38 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: Other concomitant pain disease Suicidal attempts within 5 years Suicida ideation Severe psychiatric disease Allergy against naltrexon Abuse of alcohol or other substances Use of opioid within 8 weeks Pregnancy

Design outcomes

Primary

Measure	Time frame
Main Objective: To test different doses of low dosis naltrexone (LDN) in patients with fibromyalgia and to estimate effective dose in 50% of cases. ;Secondary Objective: Not applicable;Primary end point(s): Average daily pain the last 3 days on a 0-100 numeric rating scale 7-point Likert scale stating subjective effect of the treatment The effect is considered positive if pain is decreased with 30% or if the subjects rates their condition improved according to the 7-point Likert scale. Effect is evaluated to be positive, if one of the 3 positive statements on this transition scale is chosen.;Timepoint(s) of evaluation of this end point: At baseline. After 2 weeks and 3 weeks treatment.	—

Measure

Time frame

Main Objective: To test different doses of low dosis naltrexone (LDN) in patients with fibromyalgia and to estimate effective dose in 50% of cases. ;Secondary Objective: Not applicable;Primary end point(s): Average daily pain the last 3 days on a 0-100 numeric rating scale 7-point Likert scale stating subjective effect of the treatment The effect is considered positive if pain is decreased with 30% or if the subjects rates their condition improved according to the 7-point Likert scale. Effect is evaluated to be positive, if one of the 3 positive statements on this transition scale is chosen.;Timepoint(s) of evaluation of this end point: At baseline. After 2 weeks and 3 weeks treatment.

—

Secondary

Measure	Time frame
Secondary end point(s): Fibromyalgia Impact Questionnaire, symptom part (sFIQR) Insonnia Severity Index (SSI);Timepoint(s) of evaluation of this end point: At baseline After 2 and 3 weeks treatment	—

Countries

Denmark

Contacts

Public ContactKarin Plesner

Anæstesiologisk-intensiv afd V, Odense Universitets Hospital

karin.bruun.plesner@rsyd.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026