Placebo-controlled, pharmacological clinical trial to evaluate the effectiveness, cost-utility and neurobiological effects Naltrexone in patients with fibromyalgia

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: EUCTR2021-002534-16-ES
• Lead Sponsor: Fundació Sant Joan de Déu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-12
• Last Update Posted: 26 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

1. Women between 18 and 70 years old.
2. FM diagnosis according to ACR 2016 criteria.
3. Report musculoskeletal pain at least moderate (> 4 out of 10) during the last 6 months.
4. Comprehension of Spanish.
5. Written informed consent of the patient himself.
* Additional inclusion criteria for the biomarker substudy
1. Be right-handed (for neuroimaging tests).
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) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1. Opioid treatment in the past 6 months.
2. Diagnosis of severe medical / psychiatric illnesses (eg, cancer, severe depressive disorder, psychotic disorder, and schizophrenia).
3. Being pregnant (or planning to be during the study period) or breast-feeding.
4. Known allergy to Naltrexone or Naloxone.
5. Hematological disorders.
6. Abnormal liver function.
7. Take anticoagulant medication.
8. Consume alcohol during the study period.
9. Participate in another clinical trial.
* Additional exclusion criteria biomarker substudy
1. Presence of other comorbid rheumatologic disorders (eg, rheumatoid arthritis, lupus)
2. Fever (> 38ºC) or infection in the last 2 weeks.
3. Vaccination last 4 weeks.
4. Take drugs with anti-inflammatory effects in the 72 hours prior to blood / neuroimaging.
5. Phobia of needles; inability to be evaluated by MRI (due to claustrophobia, metal implants, pacemakers, etc.).
6. BMI> 36kg / m2.
7. Consume> 8 units of caffeine per day.
8. Smoking> 10 cigarettes / day.

Study & Design

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