RECRUITING

Ketamine for Multiple Sclerosis Fatigue

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Low-Dose Ketamine Infusion for the Treatment of Multiple Sclerosis Fatigue (INKLING-MS)

Quick Facts

Study Start:2023-01-01

Study Completion:2026-03-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05378100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Subject must be a man or woman, 18 to 65 years of age, inclusive. * Subject must be medically stable based on physical examination, medical history, and vital signs * Subject must meet McDonald 2017 diagnostic criteria for multiple sclerosis based on the PI review of the medical records * Subject must complain from fatigue as one of their main symptoms and have a screening MFIS score equal or higher than the cutoff based on gender, age, and education displayed in Table-226 * Subject must be ambulatory (able to walk at least 20 feet using bilateral assistance) * Subject must have internet and email access and ability to use a computer or tablet or smartphone * Subjects that are currently taking medication for alleviating fatigue (such as amantadine, modafinil and armodafinil, and amphetamine-like psychostimulants) at Screening are eligible to participate unless the medication is one of the disallowed therapies (Table 3). Subjects taking a fatigue medication at the Screening visit must have been receiving a stable dose for at least four weeks before the Screening visit and be willing to continue the medication at the same dose for the duration of the study.	* BDI-II score of more than 29 (indicating severe depression) * Having a known clear cause for secondary fatigue, such as untreated sleep apnea, untreated hypothyroidism, chronic liver disease, history of moderate to severe anemia (hemoglobin concentration of less than 9 gr/dl in men or less than 8 gr/dl in women). * Neurodegenerative disorders other than relapsing or progressive MS * Breastfeeding or pregnant * History of coronary artery disease or congestive heart failure * Uncontrolled hypertension at Screening (history of high blood pressure and screening systolic blood pressure \>160 or diastolic blood pressure\>100) * History of severe liver disease, including cirrhosis * Terminal medical conditions * Currently treated for active malignancy * Alcohol or substance abuse in the past year (except marijuana or other cannabinoids) * A history of intolerance or allergic or anaphylactic reaction to ketamine or midazolam * Clinically unstable medical or psychiatric disorders that require acute treatment as determined by the PI * History of severe or untreated coronary artery disease or history of congestive heart failure * History of prior ischemic or hemorrhagic stroke and cerebral vascular aneurysms. * History of recurrent seizures or epilepsy * Taking any disallowed therapy(ies), as noted in the protocol.

Inclusion Criteria

Exclusion Criteria

* Subject must be a man or woman, 18 to 65 years of age, inclusive.
* Subject must be medically stable based on physical examination, medical history, and vital signs
* Subject must meet McDonald 2017 diagnostic criteria for multiple sclerosis based on the PI review of the medical records
* Subject must complain from fatigue as one of their main symptoms and have a screening MFIS score equal or higher than the cutoff based on gender, age, and education displayed in Table-226
* Subject must be ambulatory (able to walk at least 20 feet using bilateral assistance)
* Subject must have internet and email access and ability to use a computer or tablet or smartphone
* Subjects that are currently taking medication for alleviating fatigue (such as amantadine, modafinil and armodafinil, and amphetamine-like psychostimulants) at Screening are eligible to participate unless the medication is one of the disallowed therapies (Table 3). Subjects taking a fatigue medication at the Screening visit must have been receiving a stable dose for at least four weeks before the Screening visit and be willing to continue the medication at the same dose for the duration of the study.

* BDI-II score of more than 29 (indicating severe depression)
* Having a known clear cause for secondary fatigue, such as untreated sleep apnea, untreated hypothyroidism, chronic liver disease, history of moderate to severe anemia (hemoglobin concentration of less than 9 gr/dl in men or less than 8 gr/dl in women).
* Neurodegenerative disorders other than relapsing or progressive MS
* Breastfeeding or pregnant
* History of coronary artery disease or congestive heart failure
* Uncontrolled hypertension at Screening (history of high blood pressure and screening systolic blood pressure \>160 or diastolic blood pressure\>100)
* History of severe liver disease, including cirrhosis
* Terminal medical conditions
* Currently treated for active malignancy
* Alcohol or substance abuse in the past year (except marijuana or other cannabinoids)
* A history of intolerance or allergic or anaphylactic reaction to ketamine or midazolam
* Clinically unstable medical or psychiatric disorders that require acute treatment as determined by the PI
* History of severe or untreated coronary artery disease or history of congestive heart failure
* History of prior ischemic or hemorrhagic stroke and cerebral vascular aneurysms.
* History of recurrent seizures or epilepsy
* Taking any disallowed therapy(ies), as noted in the protocol.

Contacts and Locations

Study Contact

Lauren Vega, BSN

CONTACT

410-614-1522

ldimarc2@jhmi.edu

Study Locations (Sites)

Johns Hopkins University

Baltimore, Maryland, 21287

United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-01

Study Completion Date2026-03-01

Study Record Updates

Study Start Date2023-01-01

Study Completion Date2026-03-01

Terms related to this study

Additional Relevant MeSH Terms

Multiple Sclerosis Fatigue