We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ketamine for Multiple Sclerosis Fatigue (INKLING-MS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05378100
Recruitment Status : Not yet recruiting
First Posted : May 18, 2022
Last Update Posted : September 9, 2022
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE May 12, 2022
First Posted Date  ICMJE May 18, 2022
Last Update Posted Date September 9, 2022
Estimated Study Start Date  ICMJE December 1, 2022
Estimated Primary Completion Date December 1, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 12, 2022)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2022)
  • Fatigue Severity Scale (FSS) [ Time Frame: 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.
  • Epworth Sleepiness Scale (ESS) [ Time Frame: 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.
  • Beck Depression Inventory-II (BDI-II) [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine for Multiple Sclerosis Fatigue
Official Title  ICMJE Low-Dose Ketamine Infusion for the Treatment of Multiple Sclerosis Fatigue (INKLING-MS)
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis Fatigue
Intervention  ICMJE
  • Drug: Ketamine
    Infusion of ketamine 0.5 mg/kg over 40 minutes
  • Drug: Midazolam
    Infusion of midazolam 0.05 mg/kg over 40 minutes
Study Arms  ICMJE
  • Experimental: Ketamine-Ketamine
    Participants in this arm will receive two infusions of ketamine four weeks apart.
    Intervention: Drug: Ketamine
  • Experimental: Ketamine-Midazolam
    Participants in this arm will receive one infusion of ketamine followed four weeks later by an infusion of midazolam.
    Interventions:
    • Drug: Ketamine
    • Drug: Midazolam
  • Experimental: Midazolam-Ketamine
    Participants in this arm will receive one infusion of midazolam followed four weeks later by an infusion of ketamine.
    Interventions:
    • Drug: Ketamine
    • Drug: Midazolam
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 12, 2022)
110
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 1, 2026
Estimated Primary Completion Date December 1, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lauren Vega, BSN 410-614-1522 ldimarc2@jhmi.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05378100
Other Study ID Numbers  ICMJE IRB00322473
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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.

Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Current Responsible Party Johns Hopkins University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Johns Hopkins University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE United States Department of Defense
Investigators  ICMJE Not Provided
PRS Account Johns Hopkins University
Verification Date September 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP