Magnetic Resonance Imaging Study of JM-4 in Multiple Sclerosis/Clinically Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03887065
• Date of registration: 10/03/2019
• Prospective Registration: Yes
• Primary sponsor: Cook, Stuart, MD
• Public title: Magnetic Resonance Imaging Study of JM-4 in Multiple Sclerosis/Clinically Patients
• Scientific title: Magnetic Resonance Imaging 12 Day Study for Multiple Sclerosis/Clinically Isolated Syndrome Trial of JM-4 Novel Human Peptide
• Date of first enrolment: June 15, 2019
• Target sample size: 15
• Recruitment status: Not yet recruiting
• URL: https://clinicaltrials.gov/show/NCT03887065
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Early Phase 1

Contacts

• Name: Stuart Cook, MD
• Affiliation: VA Medical Center

• Name: Stuart Cook, MD

Key inclusion & exclusion criteria

Inclusion Criteria:

- Definite MS (McDonald criteria) or CIS

- GAD(+) MRI brain lesion on screening exam, with or without clinical activity followed
by a baseline MRI

- EDSS of 0-5.5 inclusive

- Weight of 40-115 kg

- Females must be post-menopausal or surgically sterilized or use a hormonal
contraceptive, intra-uterine device or diaphragm with spermicide during the study

- Not be pregnant or breast feeding

- Males must be willing to use contraception during each day of the study

- Be willing to comply with study procedures and protocols for the duration of the study

- Voluntarily provide informed consent

- Be wiling and physically able to attend the study center as required for all study
screening and procedures

Exclusion Criteria:

- Taking Tysabri, Gilenya, Tecfidera, Aubagio, Ocrevus or other immunosuppressive drugs
within the prior 3 months

- Received Mitoxantrone or Lemtrada at any time

- Consumption of corticosteroids within the past 30 days

- Current or less than 5 years prior malignancy (excluding basal cell or squamous cell
skin cancer)

- Serious systemic disorder which might, in the opinion of the investigators, interfere
with safety, compliance, treatment or evaluation of efficacy. Conditions would include
but not be limited to significant cardiac, liver, kidney, lung or cerebrovascular
disease, HIV, serious infections, serous psychiatric disease or poorly controlled
diabetes mellitus

- aversion, intolerance or allergy to repeated MRI with gadolinium administration



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: JM-4

Primary Outcome(s)

Change in GAD(+) brain lesions measured via MRI scan [Time Frame: From initial dose through 8 days after initiation of dosing]

Number of patients with treatment-related adverse events [Time Frame: From initial dose through 8 days after initiation of dosing]

Secondary Outcome(s)

Treatment-induced changes in Expanded Disability Status Score in patients [Time Frame: Prior to initial dose through 8 days post-initial treatment]

Changes in neurological exam [Time Frame: Prior to initial dose through 8 days post-initial treatment]

Changes in the ability of patients to complete a timed 25-foot walk [Time Frame: From initial dosing through 8 days post-initiation of dosing]

Secondary ID(s)

JM-4-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors