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

• Status: Unknown status
• Trial end date: 2020-03-15
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 0/1 study of MS patients to determine the safety and potential efficacy of a novel, small human peptide designated as JM-4. The study will involve treatment for 5-7 days with JM-4 to determine the effects of Gadolinium(+) lesion number and volume in the brains of patients.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cook, Stuart, MD

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