Ketamine for MS Fatigue

NCT06064162 | Completed Early Phase 1 FDA Drug

• 1 other identifier: REDI2022MS
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

MS related Fatigue

Outcome Measures

Primary Outcomes (1)

• Improve Fatigue Scores

  a statistically significant change in the level of fatigue score as measured by the Multiple Schlerosis fatigue scales: Modified Fatigue Impact Scale (MFIS) between baseline and day 28 post study drug infusion. Rating scale is 0 to 4 with 0 being "never" and 4 being "almost always."

  28 days post study drug infusion

Secondary Outcomes (1)

• Improve Quality of Life

  Between baseline and day 28

Study Arms (2)

Ketamine (active treatment)

ACTIVE COMPARATOR

dose of 0.5 mg/kg intravenously over 40 minutes on day 1

Drug: ketamine

Saline (placebo treatment)

PLACEBO COMPARATOR

Placebo (saline solution) over 40 minutes on day 1

Drug: ketamine

Interventions

ketamine DRUG

60mg (.5mg/kg over 40 minutes intravenously)

Also known as: Ketalar

Ketamine (active treatment); Saline (placebo treatment)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female and Male patients with any form of CDMS ages 18-65 inclusive
• Report fatigue which is interfering with QOL
• Able and willing to sign informed consent
• Stable on DMT for at least 3 months prior to baseline visit
• Not experiencing an MS relapse within 90 days prior to baseline visit.
• Must agree to practice an acceptable method of contraception
• Experiencing significant fatigue due to MS (MFIS of ≥10)

You may not qualify if:

• Allergy to Ketamine
• Taking medications which may interact with ketamine
• Change in DMT within 3 months prior to baseline visit
• MS relapse within 90 days of the baseline visit
• Confirmed diagnosis of untreated Sleep Apnea
• Confirmed diagnosis of periodic limb movement disorder
• Serious infection in the 30 days prior to baseline visit.
• Patients with significant comorbid conditions:
• Untreated hypertension (SBP\>160, DBP\>100 at baseline)
• Liver disease
• Significant renal disease
• History of cardiac arrhythmia
• Any comorbidities which at the opinion of the investigators post undue risk
• Current alcohol or drug abuse
• Participation in another interventional clinical trial in the past 3 months.

Sponsors & Collaborators

• Alta Bates Summit Medical Center: lead

Study Sites (1)

Alta Bates Summit Medical Center

Berkeley, California, 94705, United States

Location

Related Publications (11)

• 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.

  PMID: 32633662 BACKGROUND

• 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.

  PMID: 30312839 BACKGROUND

• 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.

  PMID: 22935407 BACKGROUND

• 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.

  PMID: 17409388 BACKGROUND

• 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.

  PMID: 15824337 BACKGROUND

• 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.

  PMID: 24963407 BACKGROUND

• 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. Epub 2020 Nov 23.

  PMID: 33242419 BACKGROUND

• 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.

  PMID: 29464379 BACKGROUND

• 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.

  PMID: 31741743 BACKGROUND

• 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.

  PMID: 19737850 BACKGROUND

• Beard C, Hsu KJ, Rifkin LS, Busch AB, Bjorgvinsson T. Validation of the PHQ-9 in a psychiatric sample. J Affect Disord. 2016 Mar 15;193:267-73. doi: 10.1016/j.jad.2015.12.075. Epub 2015 Dec 31.

  PMID: 26774513 BACKGROUND

Related Links

• National Multiple Sclerosis Society

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Deepak Soneji, MD

  Sutter East Bay Medical Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 3, 2023
• Study Start: December 5, 2023
• Primary Completion: May 5, 2025
• Study Completion: May 5, 2025
• Last Updated: June 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)