Pilot randomized active-placebo-controlled trial of low-dose ketamine for the treatment of multiple sclerosis-related fatigue

Fatigue is the most common symptom of MS and has no effective pharmacotherapy. To determine the tolerability, safety, and efficacy of low-dose ketamine infusion for MS-related fatigue. In this double-blind, randomized, active-placebo-controlled trial, 18 subjects with multiple sclerosis (MS) and rep...

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Bibliographic Details
Published in:Multiple sclerosis Vol. 27; no. 6; p. 942
Main Authors: Fitzgerald, Kathryn C, Morris, Bridget, Soroosh, Aurash, Balshi, Alexandra, Maher, Dermot, Kaplin, Adam, Nourbakhsh, Bardia
Format: Journal Article
Language:English
Published: England 01.05.2021
Subjects:
Double-Blind Method
Fatigue - drug therapy
Fatigue - etiology
Humans
Ketamine - adverse effects
Multiple Sclerosis - complications
Multiple Sclerosis - drug therapy
Pilot Projects
Treatment Outcome
Multiple sclerosis
fatigue
ketamine
midazolam
randomized controlled trial
ISSN:1477-0970, 1477-0970
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Summary:Fatigue is the most common symptom of MS and has no effective pharmacotherapy. To determine the tolerability, safety, and efficacy of low-dose ketamine infusion for MS-related fatigue. In this double-blind, randomized, active-placebo-controlled trial, 18 subjects with multiple sclerosis (MS) and reported fatigue received a single intravenous infusion of ketamine (0.5 mg/kg) or midazolam (0.05 mg/kg). The primary outcome was change in Daily Fatigue Severity (DFS) for 7 days following the infusion. Secondary outcomes included Fatigue Severity Scale (FSS) and Modified Fatigue Impact Scale (MFIS) measured up to day 28 post-infusion. We analyzed changes in all outcomes using mixed-effect models. In total, 18 participants were enrolled; 67% participants received ketamine. Side effects of ketamine were transient. No change in the DFS was observed after 7 days (-0.10 point; 95% confidence interval (CI): -0.32, 0.12;  = 0.40). We observed a trend in reduced FSS scores at 1 week (-5.2 points; 95% CI: -10.4, 0.14;  = 0.06) and a clinically and statistically significant reduction in MFIS score at day 28 (-13.5 point; 95% CI: -25.0, -1.98;  = 0.04). Ketamine infusions were safe and well-tolerated. While no change in DFS after 7 days was observed, secondary analyses suggest a benefit of ketamine infusion for reduction of longer term fatigue severity in people with MS.
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ISSN:1477-0970
1477-0970
DOI:10.1177/1352458520936226