Low dose naltrexone for treatment of pain in patients with fibromyalgia

Low dose naltrexone for treatment of pain in patients with fibromyalgia - effect via central mechanism? A randomized, double-blinded, placebo-controlled, cross-over study - Low dose naltrexone

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002972-26-DK

Enrollment

Registered

2015-10-14

Start date

2015-12-14

Completion date

Unknown

Last updated

2020-04-14

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

Conditions

Pain in patients with fibromylagia MedDRA version: 20.1 Level: LLT Classification code 10049475 Term: Chronic pain System Organ Class: 100000004867

Interventions

Product Name: low dose Naltrexon Product Code: LDN Pharmaceutical Form: Tablet INN or Proposed INN: Naltrexone Other descriptive name: NALTREXONE HYDROCHLORIDE Concentration unit: mg milligram(s) Conc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - > 18 years - Fibromyalgi - Patient in one of the involved pain centre in the study - No inflammatory rheumatic pain condition - Women - treatment with contrceptiva if not menopausal 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 70 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Cancer - Treatment with opioids (other stable analgesic treatment 14 days before study start is allowed - No change in stable analgesic treatment (p.n. paracetamol is allowed) - Pregnant/breatfeeding - Don´t speak danish - Allergic to ingredient

Design outcomes

Primary

Measure	Time frame
Main Objective: Main objective is to investigate effect and mechanism of low dose naltrexone in the treatment of pain in patients with fibromyalgia;Secondary Objective: Secondary objectives: - fatigue - sleep problems - activity level - side effect of low dose naltrexone - pain intensity in relation to experimental pain testing;Primary end point(s): Pain intensity Functionality;Timepoint(s) of evaluation of this end point: End of trial	—

Measure

Time frame

Main Objective: Main objective is to investigate effect and mechanism of low dose naltrexone in the treatment of pain in patients with fibromyalgia;Secondary Objective: Secondary objectives: - fatigue - sleep problems - activity level - side effect of low dose naltrexone - pain intensity in relation to experimental pain testing;Primary end point(s): Pain intensity Functionality;Timepoint(s) of evaluation of this end point: End of trial

—

Secondary

Measure	Time frame
Secondary end point(s): - fatigue - sleep problems - activity level - side effect of low dose naltrexone - pain intensity in relation to experimental pain testing;Timepoint(s) of evaluation of this end point: End of trial	—

Countries

Denmark

Contacts

Public ContactFriklinikken

Smerteklinikken

trine.andresen2@rsyd.dk004579718098

Outcome results

None listed

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