Clinical TrialFibromyalgiaEsketaminePlaceboEsketaminePlaceboPlaceboTerminated

ESKETamine for FIBromyalgia Treatment

This interventional trial (n=23 actual) randomised sequential study tests IV S-ketamine (0.2 mg/kg and 0.4 mg/kg) versus an active comparator (clonidine + magnesium) for fibromyalgia.

Target Enrollment
23 participants
Study Type
Phase NA interventional
Design
Randomized, triple Blind

Detailed Description

Randomized, sequential interventional study in patients with fibromyalgia evaluating supportive-care use of intravenous S-ketamine at 0.2 mg/kg and 0.4 mg/kg compared with an active comparator (clonidine 1 µg/kg plus magnesium sulfate 40 mg/kg).

Primary objective is supportive care for pain reduction and quality-of-life improvement in fibromyalgia; outcomes include pain measures and clinical safety/tolerability assessments.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Study Arms & Interventions

S-ketamine low

experimental

S-ketamine 0.2 mg/kg IV plus clonidine+magnesium active comparator per protocol.

Interventions

  • Esketamine0.2 mg/kg
    via IV• single dose

    S-ketamine 0.2 mg/kg IV infusion.

  • Placebo
    via IV• single dose

    Clonidine 1 µg/kg + magnesium sulfate 40 mg/kg diluted in 45 ml saline (active comparator).

S-ketamine high

experimental

S-ketamine 0.4 mg/kg IV plus clonidine+magnesium active comparator per protocol.

Interventions

  • Esketamine0.4 mg/kg
    via IV• single dose

    S-ketamine 0.4 mg/kg IV infusion.

  • Placebo
    via IV• single dose

    Clonidine 1 µg/kg + magnesium sulfate 40 mg/kg diluted in 45 ml saline (active comparator).

Clonidine + magnesium

active comparator

Active comparator: clonidine 1 µg/kg + magnesium sulfate 40 mg/kg in 45 ml saline.

Interventions

  • Placebo
    via IV• single dose

    Clonidine 1 µg/kg + magnesium sulfate 40 mg/kg diluted in 45 ml sodium chloride.

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Patients suffering from chronic pain (as defined by the International Association for the Study of Pain) diagnosed as fibromyalgia according to the American College of Rheumatology 2016 criteria
  • Patients qualified for treatment by S-ketamine as established by local clinical practice
  • Aged 18–65 years

Exclusion Criteria

No exclusion criteria listed.

Study Details

Locations

Grand Hôpital de Charleroi — Gilly, Hainaut, Belgium

Your Library