Clinical TrialEsketaminePlaceboCompleted

Pharmacokinetic-Pharmacodynamic Modeling of S(+)-Ketamine in Fibromyalgia: A Randomized, Double-Blind, Active Placebo-Controlled Trial

Randomized double-blind active placebo-controlled trial (LUMC Department of Anesthesiology, Leiden, Netherlands) of a single 30-minute IV infusion of S(+)-ketamine 0.5 mg/kg vs midazolam 5 mg (active placebo) in adult fibromyalgia patients (ACR 1990 criteria, baseline spontaneous pain VAS ≥5). Target enrollment: 24 (12 per arm). Primary outcomes: spontaneous fibromyalgia pain (VAS, acute phase at 45–180 min) and plasma S-ketamine/S-norketamine concentrations for PKPD modeling. Secondary outcomes: Fibromyalgia Impact Questionnaire (FIQ) and experimental heat pain (thermode VAS), both assessed weekly over 8 weeks of follow-up. Additional registry IDs: NL1296 (new NTR), NL23851.058.08 (CCMO), NL-OMON 22499. Supported by TREND Delft.

Target Enrollment
24 participants
Study Type
interventional
Design
Randomized, double Blind

Study Arms & Interventions

S-ketamine

experimental

30-min intravenous infusion of S-ketamine

Interventions

  • Esketamine0.5 mg/kg
    via IV• single dose• 1 doses total

    30-min infusion

Midazolam

placebo

30-min intravenous infusion of midazolam (active placebo)

Interventions

  • Placebo5 mg
    via IV• single dose• 1 doses total

    30-min infusion; used as an active placebo to control for sedation and side effects

Primary Results(1 publication)

Participants

N = 24Mean age: 39.1–45.2 across armsI. et al. 2012 →

Response Rates

> 50% reduction in spontaneous fibromyalgia pain

8/12(66.7%)·I. et al. 2012 →
3/12(25.0%)·I. et al. 2012 →
6/12(50.0%)·I. et al. 2012 →
3/12(25.0%)·I. et al. 2012 →

> 50% reduction in pain

2/12(16.7%)·I. et al. 2012 →
2/12(16.7%)·I. et al. 2012 →

Adverse Events (from all publications)

Arm / GroupnAny TEAESevereSeriousDiscont.
S-ketamineexperimental12———0(0.0%)
Midazolamplacebo12———0(0.0%)

* Psychotomimetic side effects (Bowdle questionnaire) were measured. 5 out of 13 tested items were greater in S-ketamine group at t=45 min. Total Bowdle scale showed no treatment effect (P=0.08).

* Psychotomimetic side effects (Bowdle questionnaire) were measured. Total Bowdle scale showed no treatment effect (P=0.08).

Study Details

  • Status
    Completed
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment24 participants
  • Timeline
    Start: 2010-02-01
    End: 2011-04-01
  • Compounds
    EsketaminePlacebo

Related Publications

Absence of long-term analgesic effect from a short-term S-ketamine infusion on fibromyalgia pain: A randomized, prospective, double blind, active placebo-controlled trial

Published
Authors
Noppers, I., Niesters, M., Swartjes, M., Bauer, M., Aarts, L., Geleijnse, N., Mooren, R., Dahanl, A., Sarton, E.

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