Clinical TrialFibromyalgiaKetamineEsketamineUnknown status

Comparison of Ketamine and Esketamine in Patients Suffering From Fibromyalgia Syndrome

This single-centre, prospective, randomized, double-blind, crossover trial (n=50) aims to compare the efficacy of ketamine and esketamine in ambulatory patients treated for fibromyalgia syndrome in a pain clinic.

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

Detailed Description

Randomised, triple-blind crossover comparing intravenous ketamine (0.3 mg/kg) and intravenous esketamine (0.15 mg/kg) in patients with fibromyalgia; each patient receives two 1-hour infusions of each drug separated by 6 weeks with a 1-week washout.

Primary outcome is change on the Fibromyalgia Impact Questionnaire (FIQ); safety and adverse effects monitored acutely during and after infusions and at follow-up.

Study Protocol

Preparation

sessions

Dosing

4 sessions
60 min each

Integration

sessions

Study Arms & Interventions

Ketamine vs Esketamine

experimental

Randomised crossover comparing IV ketamine 0.3 mg/kg and IV esketamine 0.15 mg/kg; each drug given as two 1-hour infusions separated by 6 weeks; 1-week washout between periods.

Interventions

  • Ketamine0.3 mg/kg
    via IV• per infusion• 2 doses total

    Each infusion given over 1 hour; two infusions per treatment period.

  • Esketamine0.15 mg/kg
    via IV• per infusion• 2 doses total

    Each infusion given over 1 hour; two infusions per treatment period.

Participants

Ages
18 – 75
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Male and female
  • Between 18 and 75 years old
  • Reads and writes French
  • Diagnosis of fibromyalgia syndrome according to Widespread Pain Index (WPI) and Symptom Severity Scale (SSS) score ≥ 13/31
  • Both molecules (Ketamine and Esketamine) were administered at least once during an analgesic infusion session in Pain Clinic
  • Patient with regular medical follow-up by a pain specialist at least 3 times a year

Exclusion Criteria

  • Exclusion Criteria:
  • Allergy or intolerance to Ketamine or Esketamine
  • Current infection, fever
  • Pregnant or breastfeeding woman
  • Serious cardiovascular disorders and severe hypertension
  • Increased pressure of cerebrospinal fluid and severe intracranial disease
  • Acute intermittent porphyria
  • Untreated epilepsy
  • Untreated glaucoma
  • Difficult or impossible intravenous access
  • Chronic Liver Disease Child-Pugh C

Study Details

  • Status
    Unknown status
  • Phase
    Phase NA
  • Type
    interventional
  • Design
    Randomizedtriple Blind
  • Target Enrollment50 participants
  • Timeline
    Start: 2021-07-01
    End: 2022-09-30
  • Compounds
    KetamineEsketamine
  • Topic
    Fibromyalgia

Locations

CHU de Charleroi — Lodelinsart, Hainaut, Belgium

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