Magnetic Resonance Imaging Study of JM-4 in Multiple Sclerosis/Clinica
Magnetic Resonance Imaging 12 Day Study for Multiple Sclerosis/Clinically Isolated Syndrome Trial of JM-4 Novel Human Peptide
What it found
We found no results in the registry or in papers.
What was tested
Treatment tested
- JM-4
What it measured
Main measures
Number of patients with treatment-related adverse events
From initial dose through 8 days after initiation of dosing
SafetyChange in GAD(+) brain lesions measured via MRI scan
From initial dose through 8 days after initiation of dosing
MRI lesions
Other measures (3)
Changes in the ability of patients to complete a timed 25-foot walk
From initial dosing through 8 days post-initiation of dosing
Disability progressionWalking and mobilityTreatment-induced changes in Expanded Disability Status Score in patients
Prior to initial dose through 8 days post-initial treatment
Disability progressionChanges in neurological exam
Prior to initial dose through 8 days post-initial treatment
Vision
Who could take part
Early (CIS/RIS) · 18 to 55 · EDSS 0 to 5.5
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Loading reviews and guidelines…
History
Started
Jun 2019
Main results due
Dec 2019
Finished
Mar 2020