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Ketamine for Multiple Sclerosis Fatigue (INKLING-MS)

Primary Purpose

Multiple Sclerosis Fatigue

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Ketamine

Midazolam

About this trial

This is an interventional treatment trial for Multiple Sclerosis Fatigue

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Johns Hopkins UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Ketamine-Ketamine

Ketamine-Midazolam

Midazolam-Ketamine

Arm Description

Participants in this arm will receive two infusions of ketamine four weeks apart.

Participants in this arm will receive one infusion of ketamine followed four weeks later by an infusion of midazolam.

Participants in this arm will receive one infusion of midazolam followed four weeks later by an infusion of ketamine.

Outcomes

Primary Outcome Measures

Modified Fatigue Impact Scale (MFIS) Score

The total score of the MFIS ranges from 0 to 84. Higher scores denote more severe fatigue.

Secondary Outcome Measures

Fatigue Severity Scale (FSS)

The total score of the FSS ranges from 1 to 7. Higher scores denote more severe fatigue.

Epworth Sleepiness Scale (ESS)

The total score of the ESS ranges from 0 to 24. Higher scores denote more severe sleepiness.

Beck Depression Inventory-II (BDI-II)

The total score of the BDI-IIranges from 0 to 63. Higher scores denote more severe depression.

Full Information

NCT ID

NCT05378100

First Posted

May 12, 2022

Last Updated

January 4, 2023

Sponsor

Johns Hopkins University

Collaborators

United States Department of Defense

1. Study Identification

Unique Protocol Identification Number

NCT05378100

Brief Title

Ketamine for Multiple Sclerosis Fatigue

Acronym

INKLING-MS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 1, 2023 (Actual)

Primary Completion Date

December 1, 2025 (Anticipated)

Study Completion Date

March 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Johns Hopkins University

Collaborators

United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis Fatigue

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ketamine-Ketamine

Arm Type

Experimental

Arm Description

Participants in this arm will receive two infusions of ketamine four weeks apart.

Arm Title

Ketamine-Midazolam

Arm Type

Experimental

Arm Description

Participants in this arm will receive one infusion of ketamine followed four weeks later by an infusion of midazolam.

Arm Title

Midazolam-Ketamine

Arm Type

Experimental

Arm Description

Participants in this arm will receive one infusion of midazolam followed four weeks later by an infusion of ketamine.

Intervention Type

Drug

Intervention Name(s)

Ketamine

Intervention Description

Infusion of ketamine 0.5 mg/kg over 40 minutes

Intervention Type

Drug

Intervention Name(s)

Midazolam

Intervention Description

Infusion of midazolam 0.05 mg/kg over 40 minutes

Primary Outcome Measure Information:

Title

Modified Fatigue Impact Scale (MFIS) Score

Description

The total score of the MFIS ranges from 0 to 84. Higher scores denote more severe fatigue.

Time Frame

Baseline (infusion visit) through four weeks after the infusion.

Secondary Outcome Measure Information:

Title

Fatigue Severity Scale (FSS)

Description

The total score of the FSS ranges from 1 to 7. Higher scores denote more severe fatigue.

Time Frame

Baseline (infusion visit) through four weeks after the infusion.

Title

Epworth Sleepiness Scale (ESS)

Description

The total score of the ESS ranges from 0 to 24. Higher scores denote more severe sleepiness.

Time Frame

Baseline (infusion visit) through four weeks after the infusion.

Title

Beck Depression Inventory-II (BDI-II)

Description

The total score of the BDI-IIranges from 0 to 63. Higher scores denote more severe depression.

Time Frame

Baseline (infusion visit) through four weeks after the infusion.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lauren Vega, BSN

Phone

410-614-1522

ldimarc2@jhmi.edu

Facility Information:

Facility Name

Johns Hopkins University

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mahsa Ghajarzadeh, MD, PhD

mghajar2@jhmi.edu

First Name & Middle Initial & Last Name & Degree

Lauren Vega, BSN

Ldimarc2@jhmi.edu

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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.

Learn more about this trial

Ketamine for Multiple Sclerosis Fatigue

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