TY - JOUR
T1 - Low-dose ketamine infusion for the treatment of multiple sclerosis fatigue (INKLING-MS)
T2 - Study protocol for a randomized, double-blind, active placebo-controlled phase II trial
AU - Ghajarzadeh, Mahsa
AU - Roman, Samantha
AU - Vega, Lauren
AU - Nourbakhsh, Bardia
N1 - Publisher Copyright:
© 2023 Elsevier Inc.
PY - 2023/3
Y1 - 2023/3
N2 - Background: Fatigue is one of the most common symptoms of people with Multiple Sclerosis (MS). However, currently-used medications for the treatment of fatigue probably do not work better than a placebo. In a pilot trial, we showed that one infusion of low-dose ketamine significantly improved fatigue severity measured four weeks after the infusion. Methods: 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. Participants will be randomized 1:1:1 into three groups: receiving either one or two infusions of ketamine (0.5 mg/kg over 40 min) or zero to one infusion of the active placebo (midazolam, 0.05 mg/kg over 40 min). Eligibility criteria include adult patients diagnosed with MS based on the latest criteria, complaining of fatigue as one of the main symptoms, and having a screening MFIS score higher than a pre-specified threshold. Results: One hundred and ten participants will be randomized over 30 months at Johns Hopkins MS Center. Complete enrollment is expected by mid-2025. The study's primary outcome will be the MFIS score at the end of week 4, comparing two-thirds of the participants who received ketamine with one-third who received midazolam. The secondary and exploratory outcomes (measured four weeks after the second infusion) will show how long the effects of a single infusion last and if two infusions of ketamine are better than one in improving MS fatigue. Conclusion: This study can show whether intervening in the glutamatergic pathways would improves MS fatigue.
AB - Background: Fatigue is one of the most common symptoms of people with Multiple Sclerosis (MS). However, currently-used medications for the treatment of fatigue probably do not work better than a placebo. In a pilot trial, we showed that one infusion of low-dose ketamine significantly improved fatigue severity measured four weeks after the infusion. Methods: 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. Participants will be randomized 1:1:1 into three groups: receiving either one or two infusions of ketamine (0.5 mg/kg over 40 min) or zero to one infusion of the active placebo (midazolam, 0.05 mg/kg over 40 min). Eligibility criteria include adult patients diagnosed with MS based on the latest criteria, complaining of fatigue as one of the main symptoms, and having a screening MFIS score higher than a pre-specified threshold. Results: One hundred and ten participants will be randomized over 30 months at Johns Hopkins MS Center. Complete enrollment is expected by mid-2025. The study's primary outcome will be the MFIS score at the end of week 4, comparing two-thirds of the participants who received ketamine with one-third who received midazolam. The secondary and exploratory outcomes (measured four weeks after the second infusion) will show how long the effects of a single infusion last and if two infusions of ketamine are better than one in improving MS fatigue. Conclusion: This study can show whether intervening in the glutamatergic pathways would improves MS fatigue.
KW - Fatigue
KW - Ketamine
KW - Multiple sclerosis
KW - Randomized controlled trial
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U2 - 10.1016/j.cct.2023.107106
DO - 10.1016/j.cct.2023.107106
M3 - Article
C2 - 36738917
AN - SCOPUS:85149073707
SN - 1551-7144
VL - 126
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
M1 - 107106
ER -