Fibromyalgia and Naltrexone: The FINAL study

Phase 1

• Conditions: Fibromyalgia; MedDRA version: 20.0Level: PTClassification code 10048439Term: FibromyalgiaSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2019-000702-30-DK
• Lead Sponsor: Odense University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-23
• Study Completion: 2022-12-27
• Last Update Posted: 19 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 99

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

-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”)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified