Multiple Sclerosis FatiguePhase 2INKLING-MSNCT05378100
Ketamine for Multiple Sclerosis Fatigue
A Phase 2 study testing Ketamine and Midazolam in people with Multiple Sclerosis Fatigue, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis Fatigue
- What is being tested?
- Ketamine and Midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2023to 1 Oct 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low-Dose Ketamine Infusion for the Treatment of Multiple Sclerosis Fatigue (INKLING-MS)
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.
- Conditions
- Multiple Sclerosis Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Infusion of ketamine 0.5 mg/kg over 40 minutes
MidazolamDrug
Infusion of midazolam 0.05 mg/kg over 40 minutes
| Study group | Role | What they receive |
|---|---|---|
| Ketamine-Ketamine | Experimental | Participants in this arm will receive two infusions of ketamine four weeks apart. Receives: Drug: Ketamine |
| Ketamine-Midazolam | Experimental | Participants in this arm will receive one infusion of ketamine followed four weeks later by an infusion of midazolam. Receives: Drug: Ketamine; Drug: Midazolam |
| Midazolam-Ketamine | Experimental | Participants in this arm will receive one infusion of midazolam followed four weeks later by an infusion of ketamine. Receives: Drug: Ketamine; Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Fatigue Impact Scale (MFIS) Score
The total score of the MFIS ranges from 0 to 84. Higher scores denote more severe fatigue.
Measured: Baseline (infusion visit) through four weeks after the infusion.
Secondary outcomes (3)
Fatigue Severity Scale (FSS)
The total score of the FSS ranges from 1 to 7. Higher scores denote more severe fatigue.
Measured: Baseline (infusion visit) through four weeks after the infusion.
Epworth Sleepiness Scale (ESS)
The total score of the ESS ranges from 0 to 24. Higher scores denote more severe sleepiness.
Measured: Baseline (infusion visit) through four weeks after the infusion.
Beck Depression Inventory-II (BDI-II)
The total score of the BDI-IIranges from 0 to 63. Higher scores denote more severe depression.
Measured: Baseline (infusion visit) through four weeks after the infusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start1 Jan 2023
- Primary completion21 May 2026
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis FatigueStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Bardia Nourbakhsh, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05378100
- Sponsor's protocol ID
- IRB00322473
- Acronym
- INKLING-MS
- Status last verified
- May 2026
- First submitted
- 12 May 2022
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: After completion of the study and publication of key findings, the study investigators will make Final Research Data available to researchers upon written request. Researchers must adhere to a data sharing agreement. This agreement requires users to: (1) use the data only for research purposes; (2) not share the data with unauthorized users; (3) ensure that the data are protected from unauthorized persons; (4) require that the data be returned or destroyed at the end of the analysis; (5) provide certification of IRB review and approval.
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-Dose Ketamine Infusion for the Treatment of Multiple Sclerosis Fatigue (INKLING-MS)
- ClinicalTrials.gov ID
- NCT05378100
- Acronym / sponsor ID
- INKLING-MS / IRB00322473
- Conditions
- Multiple Sclerosis Fatigue
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 21 May 2026 (actual)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 18 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ketamine-Ketamine | Experimental | Drug: KetamineParticipants in this arm will receive two infusions of ketamine four weeks apart. |
| Ketamine-Midazolam | Experimental | Drug: Ketamine, Drug: MidazolamParticipants in this arm will receive one infusion of ketamine followed four weeks later by an infusion of midazolam. |
| Midazolam-Ketamine | Experimental | Drug: Ketamine, Drug: MidazolamParticipants in this arm will receive one infusion of midazolam followed four weeks later by an infusion of ketamine. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetamineInfusion of ketamine 0.5 mg/kg over 40 minutes | Drug | Ketamine-Ketamine, Ketamine-Midazolam, Midazolam-Ketamine |
| MidazolamInfusion of midazolam 0.05 mg/kg over 40 minutes | Drug | Ketamine-Midazolam, Midazolam-Ketamine |
Primary outcome
Modified Fatigue Impact Scale (MFIS) Score
Time frame: 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.
3 secondary outcomes
Fatigue Severity Scale (FSS)
Time frame: Baseline (infusion visit) through four weeks after the infusion.
Epworth Sleepiness Scale (ESS)
Time frame: Baseline (infusion visit) through four weeks after the infusion.
Beck Depression Inventory-II (BDI-II)
Time frame: Baseline (infusion visit) through four weeks after the infusion.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: Yes. After completion of the study and publication of key findings, the study investigators will make Final Research Data available to researchers upon written request. Researchers must adhere to a data sharing agreement. This agreement requires users to: (1) use the data only for research purposes; (2) not share the data with unauthorized users; (3) ensure that the data are protected from unauthorized persons; (4) require that the data be returned or destroyed at the end of the analysis; (5) provide certification of IRB review and approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bardia Nourbakhsh, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ketamine and Midazolam in people with Multiple Sclerosis Fatigue, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Fatigue Impact Scale (MFIS) Score (time frame: Baseline (infusion visit) through four weeks after the infusion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.