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

Phase 1

Conditions: Fibromyalgia
MedDRA version: 20.0Level: LLTClassification code 10016631Term: Fibromyalgia syndromeSystem Organ Class: 100000004859
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2016-002081-31-DK

Lead Sponsor: Anæstesiologisk-intensiv afd V, Odense Universitets Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 38

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>7-point Likert scale stating subjective effect of the treatment<br><br>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.<br>After 2 weeks and 3 weeks treatment.

Secondary Outcome Measures

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