Ketamine for Multiple Sclerosis Fatigue
- Registration Number
- NCT05378100
- Lead Sponsor
- Johns Hopkins University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 110
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ketamine-Ketamine Ketamine Participants in this arm will receive two infusions of ketamine four weeks apart. Ketamine-Midazolam Ketamine Participants in this arm will receive one infusion of ketamine followed four weeks later by an infusion of midazolam. Midazolam-Ketamine Midazolam Participants in this arm will receive one infusion of midazolam followed four weeks later by an infusion of ketamine. Ketamine-Midazolam Midazolam Participants in this arm will receive one infusion of ketamine followed four weeks later by an infusion of midazolam. Midazolam-Ketamine Ketamine Participants in this arm will receive one infusion of midazolam followed four weeks later by an infusion of ketamine.
- Primary Outcome Measures
Name Time Method Modified Fatigue Impact Scale (MFIS) Score Baseline (infusion visit) through four weeks after the infusion. The total score of the MFIS ranges from 0 to 84. Higher scores denote more severe fatigue.
- Secondary Outcome Measures
Name Time Method Epworth Sleepiness Scale (ESS) Baseline (infusion visit) through four weeks after the infusion. The total score of the ESS ranges from 0 to 24. Higher scores denote more severe sleepiness.
Fatigue Severity Scale (FSS) Baseline (infusion visit) through four weeks after the infusion. The total score of the FSS ranges from 1 to 7. Higher scores denote more severe fatigue.
Beck Depression Inventory-II (BDI-II) Baseline (infusion visit) through four weeks after the infusion. The total score of the BDI-IIranges from 0 to 63. Higher scores denote more severe depression.
Trial Locations
- Locations (1)
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States