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Abstract Details

Pilot randomized active-placebo controlled double-blind trial of low dose ketamine for the treatment of multiple sclerosis-related fatigue
Multiple Sclerosis
P8 - Poster Session 8 (8:00 AM-9:00 AM)
9-020
 To determine the tolerability, safety, and efficacy of low-dose ketamine infusion for MS-related fatigue.  
Fatigue is a common and disabling symptom of multiple sclerosis (MS). Intravenous administration of low-dose ketamine, a modulator of glutamatergic transmission might improve fatigue in patients with mood disorders.  
 In this double-blind, randomized, parallel-group, active placebo-controlled trial, 18 subjects with MS and reported fatigue received a single intravenous infusion of ketamine (0.5 mg/kg) over 40 min or midazolam (0.05 mg/kg). The primary outcome measure was change in Daily Fatigue Severity (DFS), a single question asking the participants to rate fatigue severity from zero (no fatigue) to 10 (the most severe fatigue) for seven days post-infusion. Secondary outcomes included fatigue severity scale (FSS), NeuroQoL-Fatigue, Epworth Sleepiness Scale (ESS), and Beck Depression Inventory (BDI-II), measured on days 7 and 14 and modified fatigue impact scale (MFIS) measured on day 28 post-infusion. We analyzed changes in all outcomes using generalized estimating equations.
 18 participants (aged: 45.7±11.3y; 61% male) were enrolled; 12 participants received ketamine, and 6 participants received midazolam. Side effects of ketamine were largely transient and included dizziness, numbness, euphoria, impaired concentration, and elevated blood pressure. There was no significant change in the DFS after seven days (difference in the rate of change in DFS score per day between ketamine vs. midazolam: -0.10 point; 95% CI: -0.32, 0.12; p=0.40). We observed a trend in improved FSS scores at 1-week (-6.5 points; 95% CI: -13.4, 0.41; p=0.07) and a significant improvement in MFIS score on day 28 post-infusion (-13.5 point; 95% CI: -23.5, -3.5; p=0.0008). ESS scores improved significantly (-2.2 point; 95% CI: -4.2, -0.2; p=0.04). No changes in Neuro-QoL fatigue or BDI-II were observed (both p>0.05).
 Ketamine infusions were safe and well-tolerated. Results suggest a potential role for modulators of glutamatergic pathways in the treatment of MS-related fatigue.
Authors/Disclosures
Kathryn Fitzgerald, PhD (Johns Hopkins University)
PRESENTER 		Dr. Fitzgerald has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Setpoint Medical. The institution of Dr. Fitzgerald has received research support from NIH. The institution of Dr. Fitzgerald has received research support from National MS Society.
No disclosure on file
No disclosure on file
Alexandra R. Balshi Ms. Balshi has nothing to disclose.
No disclosure on file
Bardia Nourbakhsh, MD (Johns Hopkins University) Dr. Nourbakhsh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for TG Therapeutics . Dr. Nourbakhsh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alkermes. The institution of Dr. Nourbakhsh has received research support from Genentech. The institution of Dr. Nourbakhsh has received research support from National MS Society . The institution of Dr. Nourbakhsh has received research support from Department of Defense. The institution of Dr. Nourbakhsh has received research support from NIH. The institution of Dr. Nourbakhsh has received research support from Axsome Therapeutics. The institution of Dr. Nourbakhsh has received research support from TG Therapeutics .