Low-Dose Ketamine Infusion for the Treatment of Multiple Sclerosis Fatigue (INKLING-MS)
NCT: NCT05378100 ·
Status: ACTIVE NOT RECRUITING ·
Phase: Phase 2
· Sponsor: Johns Hopkins University
· Started: 2023-01-01
· Est. Completion: 2026-10-01
Official Summary
The proposed study is a single-center, phase II, randomized, double-blind, parallel-group, active-placebo-controlled trial of intravenous low-dose ketamine in patients with MS fatigue.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: QUADRUPLE
- Enrollment: 110 participants
Interventions
- DRUG: Ketamine — Infusion of ketamine 0.5 mg/kg over 40 minutes
- DRUG: Midazolam — Infusion of midazolam 0.05 mg/kg over 40 minutes
Primary Outcomes
- Modified Fatigue Impact Scale (MFIS) Score (Baseline (infusion visit) through four weeks after the infusion.)
Secondary Outcomes
- Fatigue Severity Scale (FSS) (Baseline (infusion visit) through four weeks after the infusion.)
- Epworth Sleepiness Scale (ESS) (Baseline (infusion visit) through four weeks after the infusion.)
- Beck Depression Inventory-II (BDI-II) (Baseline (infusion visit) through four weeks after the infusion.)
Trial Locations
- Johns Hopkins University, Baltimore, Maryland, United States
More Multiple Sclerosis Fatigue Trials
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.