Ketamine for Treatment of MS Fatigue

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03500289
• Date of registration: 04/04/2018
• Prospective Registration: Yes
• Primary sponsor: Johns Hopkins University
• Public title: Ketamine for Treatment of MS Fatigue
• Scientific title: Ketamine for Treatment of Multiple Sclerosis-related Fatigue
• Date of first enrolment: August 10, 2018
• Target sample size: 18
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03500289
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 1/Phase 2

Countries of recruitment

United States

Contacts

• Name: Bardia Nourbakhsh, MD, MAS
• Affiliation: Johns Hopkins University

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age between 18 years 65 years.

- Females of childbearing age must have a negative urine pregnancy test at baseline and
use an effective method of contraception during the study.

- Diagnosis of MS (according to the 2010 McDonald criteria).

- Ambulatory (at least 20 feet using bilateral assistance).

- Fatigue reportedly present and screening modified fatigue impact scale (MFIS) score
>33.

- Internet and email access and able to use a computer or tablet

Exclusion Criteria:

- Beck Depression Inventory (BDI) score of more than 30.

- 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 Appendix 2 of the protocol.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Fatigue

Intervention(s)

Drug: Ketamine

Drug: Midazolam

Primary Outcome(s)

Change in Daily Fatigue Severity Score [Time Frame: Baseline (infusion visit) through day 7]

Secondary Outcome(s)

Change in Epworth Sleepiness Scale Score [Time Frame: Baseline (infusion visit) through day 28 post-infusion]

Change in Modified Fatigue Impact Scale (MFIS) Score [Time Frame: Baseline (infusion visit) through Day 28 post-infusion]

Change in Beck Depression Inventory (BDI) Score [Time Frame: Baseline (infusion visit) through day 28 post-infusion]

Change in Fatigue Severity Scale (FSS) Score [Time Frame: Baseline (infusion visit) through day 28 post-infusion]

Change in Quality of Life in Neurological Disorders (NeuroQol) Fatigue Item Bank Score [Time Frame: Baseline (infusion visit) through day 28 post-infusion]

Secondary ID(s)

IRB00164017

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Multiple Sclerosis Society

Results

• Results available: Yes
• Date Posted: 04/08/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03500289