Using ketamine to treat fatigue in multiple sclerosis patients
Low-Dose Ketamine Infusion for the Treatment of Multiple Sclerosis Fatigue (INKLING-MS)
This study is testing if low-dose ketamine can help people with multiple sclerosis feel less tired.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT05378100 on ClinicalTrials.gov |
What this trial studies
This phase II clinical trial investigates the effects of intravenous low-dose ketamine on fatigue in patients diagnosed with multiple sclerosis. It is a randomized, double-blind, parallel-group, active-placebo-controlled study conducted at a single center. Participants will receive either ketamine or midazolam, with the aim of assessing improvements in fatigue levels as measured by specific scoring criteria. The study seeks to determine the efficacy and safety of ketamine as a potential treatment option for managing fatigue associated with multiple sclerosis.
Who should consider this trial
Good fit: Ideal candidates are men and women aged 18 to 65 who have been diagnosed with multiple sclerosis and experience significant fatigue.
Not a fit: Patients who do not experience fatigue as a primary symptom or those with contraindications to ketamine may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce fatigue in patients with multiple sclerosis, improving their quality of life.
How similar studies have performed: While the use of ketamine for various conditions has shown promise, this specific application for multiple sclerosis fatigue is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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. Exclusion Criteria: * 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.
Where this trial is running
Baltimore, Maryland
- Johns Hopkins University — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Bardia Nourbakhsh, MD — Johns Hopkins University
- Study coordinator: Lauren Vega, BSN
- Email: ldimarc2@jhmi.edu
- Phone: 410-614-1522
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.