Ketamine for MS Fatigue
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Ketamine
What it measured
Main measures
Improve Fatigue Scores
28 days post study drug infusion
Fatigue
Other measures (1)
Improve Quality of Life
Between baseline and day 28
Quality of life (reported by participants)
Who could take part
MS (type not specified) · 18 to 65
Inclusion Criteria: 1. Female and Male patients with any form of CDMS ages 18-65 inclusive 2. Report fatigue which is interfering with QOL 3. Able and willing to sign informed consent 4. Stable on DMT for at least 3 months prior to baseline visit 5. Not experiencing an MS relapse within 90 days prior to baseline visit. 6. Must agree to practice an acceptable method of contraception 7. Experiencing significant fatigue due to MS (MFIS of ≥10) Exclusion Criteria: 1. Allergy to Ketamine 2. Taking medications which may interact with ketamine 3. Change in DMT within 3 months prior to baseline visit 4. MS relapse within 90 days of the baseline visit 5. Confirmed diagnosis of untreated Sleep Apnea 6. Confirmed diagnosis of periodic limb movement disorder 7. Serious infection in the 30 days prior to baseline visit. 8. Patients with significant comorbid conditions: 1. Untreated hypertension (SBP>160, DBP>100 at baseline) 2. Liver disease 3. Significant renal disease 4. History of cardiac arrhythmia 5. Any comorbidities which at the opinion of the investigators post undue risk 9. Current alcohol or drug abuse 10. Participation in another interventional clinical trial in the past 3 months. 11. Pregnant or lactating 12. Any condition which in the opinion of the investigators will cause safety concerns for the patient, or inability to comply with the protocol.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The purpose of this study is to see whether using ketamine to increase glutamate in the prefrontal cortex can reduce Multiple Sclerosis (MS) related fatigue. The investigator proposes a prospective, crossover, randomized, placebo-controlled study to assess the efficacy and safety of low, single dose Ketamine, to assess its efficacy and safety in patients with MS-related fatigue.
Papers
Results
Fitzgerald KC, Morris B, Soroosh A, Balshi A, Maher D, Kaplin A, Nourbakhsh B. Pilot randomized active-placebo-controlled trial of low-dose ketamine for the treatment of multiple sclerosis-related fatigue. Mult Scler. 2021 May;27(6):942-953. doi: 10.1177/1352458520936226. Epub 2020 Jul 7.Results
Saligan LN, Farmer C, Ballard ED, Kadriu B, Zarate CA Jr. Disentangling the association of depression on the anti-fatigue effects of ketamine. J Affect Disord. 2019 Feb 1;244:42-45. doi: 10.1016/j.jad.2018.10.089. Epub 2018 Oct 6.Results
Induruwa I, Constantinescu CS, Gran B. Fatigue in multiple sclerosis - a brief review. J Neurol Sci. 2012 Dec 15;323(1-2):9-15. doi: 10.1016/j.jns.2012.08.007. Epub 2012 Aug 27.Results
Kos D, Kerckhofs E, Nagels G, D'hooghe MB, Ilsbroukx S. Origin of fatigue in multiple sclerosis: review of the literature. Neurorehabil Neural Repair. 2008 Jan-Feb;22(1):91-100. doi: 10.1177/1545968306298934. Epub 2007 Apr 4.Results
Stankoff B, Waubant E, Confavreux C, Edan G, Debouverie M, Rumbach L, Moreau T, Pelletier J, Lubetzki C, Clanet M; French Modafinil Study Group. Modafinil for fatigue in MS: a randomized placebo-controlled double-blind study. Neurology. 2005 Apr 12;64(7):1139-43. doi: 10.1212/01.WNL.0000158272.27070.6A.Results
Asano M, Finlayson ML. Meta-analysis of three different types of fatigue management interventions for people with multiple sclerosis: exercise, education, and medication. Mult Scler Int. 2014;2014:798285. doi: 10.1155/2014/798285. Epub 2014 May 14.Results
Nourbakhsh B, Revirajan N, Morris B, Cordano C, Creasman J, Manguinao M, Krysko K, Rutatangwa A, Auvray C, Aljarallah S, Jin C, Mowry E, McCulloch C, Waubant E. Safety and efficacy of amantadine, modafinil, and methylphenidate for fatigue in multiple sclerosis: a randomised, placebo-controlled, crossover, double-blind trial. Lancet Neurol. 2021 Jan;20(1):38-48. doi: 10.1016/S1474-4422(20)30354-9.Results
Broicher SD, Filli L, Geisseler O, Germann N, Zorner B, Brugger P, Linnebank M. Positive effects of fampridine on cognition, fatigue and depression in patients with multiple sclerosis over 2 years. J Neurol. 2018 May;265(5):1016-1025. doi: 10.1007/s00415-018-8796-9. Epub 2018 Feb 20.Results
Meca-Lallana V, Branas-Pampillon M, Higueras Y, Candeliere-Merlicco A, Aladro-Benito Y, Rodriguez-De la Fuente O, Salas-Alonso E, Maurino J, Ballesteros J. Assessing fatigue in multiple sclerosis: Psychometric properties of the five-item Modified Fatigue Impact Scale (MFIS-5). Mult Scler J Exp Transl Clin. 2019 Nov 9;5(4):2055217319887987. doi: 10.1177/2055217319887987. eCollection 2019 Oct-Dec.Results
Wesson JM, Cooper JA, Jehle LS, Lockhart SN, Draney K, Barber J. The functional index for living with multiple sclerosis: development and validation of a new quality of life questionnaire. Mult Scler. 2009 Oct;15(10):1239-49. doi: 10.1177/1352458509107019. Epub 2009 Sep 8.
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History
Started
Dec 2023
Main results due
May 2025
Finished
May 2025
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