Back to resultsMagnetic Resonance Imaging Study of JM-4 in Multiple Sclerosis/Clinically Patients
Primary Purpose
Multiple Sclerosis
Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
JM-4
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Starting dose
Intermediate dose of JM-4
High dose of JM-4
Arm Description
Three to five patients will receive a daily dose of 1 mg/kg JM-4 (in normal saline) delivered via intravenous infusion for no more than 30 minutes for up to 7 consecutive days.
Three to five patients will receive a daily dose of 4 mg/kg of JM-4 (in normal saline) via intravenous infusion for no more than 30 minutes for up to 7 consecutive days.
Three to five patients will receive a daily dose of 9 mg/kg of JM-4 (in normal saline) via intravenous infusion for no more than 30 minutes for up to 7 consecutive days.
Outcomes
Primary Outcome Measures
Number of patients with treatment-related adverse events
To determine the incidence of adverse events and any abnormal laboratory values
Change in GAD(+) brain lesions measured via MRI scan
Measurement of the number and size of GAD(+) brain lesions from baseline to post-dosing 8 days after initiation of treatment
Secondary Outcome Measures
Changes in the ability of patients to complete a timed 25-foot walk
To determine changes in timed 25 foot walk prior to treatment or 8 days after treatment
Treatment-induced changes in Expanded Disability Status Score in patients
Measurement of Expanded Disability Status scores in patients prior to treatment and after completion of treatment
Changes in neurological exam
Neurological examination of patients to check for optic nerve changes and vision changes
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03887065
Brief Title
Magnetic Resonance Imaging Study of JM-4 in Multiple Sclerosis/Clinically Patients
Official Title
Magnetic Resonance Imaging 12 Day Study for Multiple Sclerosis/Clinically Isolated Syndrome Trial of JM-4 Novel Human Peptide
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 15, 2019 (Anticipated)
Primary Completion Date
December 15, 2019 (Anticipated)
Study Completion Date
March 15, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cook, Stuart, MD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed Description
This study is the first study of JM-4 in patients with Multiple Sclerosis and is intended to show safety and potential efficacy in changing the size and/or number of GAD(+) lesions in the brain. The initial dose level of 1 mg/kg/ will establish safety of JM-4 treatment after 5-7 days of treatment via intravenous infusion over 30 minutes daily in3-5 patients with Multiple Sclerosis. MRI examinations will be conducted prior to treatment with JM-4 and 8 days after the initiation of treatment for the purpose of quantitating GAD(+) brain lesions. Once initial safety is established, the next group of 3-5 patients will receive 4 mg/kg/ of JM-4 daily for 5-7 days via 30 minute intravenous infusions, with MRI scans conducted prior to treatment and 8 days after the initial dose of JM-4. Once safety is established in this cohort of patients, a third group of patients may receive 9 mg/kg/ of JM-4 daily for 5-7 days via 30 minute infusions, with MRI scans conducted prior to the initial treatment and 8 days after the initial treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Starting dose
Arm Type
Experimental
Arm Description
Three to five patients will receive a daily dose of 1 mg/kg JM-4 (in normal saline) delivered via intravenous infusion for no more than 30 minutes for up to 7 consecutive days.
Arm Title
Intermediate dose of JM-4
Arm Type
Experimental
Arm Description
Three to five patients will receive a daily dose of 4 mg/kg of JM-4 (in normal saline) via intravenous infusion for no more than 30 minutes for up to 7 consecutive days.
Arm Title
High dose of JM-4
Arm Type
Experimental
Arm Description
Three to five patients will receive a daily dose of 9 mg/kg of JM-4 (in normal saline) via intravenous infusion for no more than 30 minutes for up to 7 consecutive days.
Intervention Type
Drug
Intervention Name(s)
JM-4
Intervention Description
Novel small human peptide derived from erythropoietin
Primary Outcome Measure Information:
Title
Number of patients with treatment-related adverse events
Description
To determine the incidence of adverse events and any abnormal laboratory values
Time Frame
From initial dose through 8 days after initiation of dosing
Title
Change in GAD(+) brain lesions measured via MRI scan
Description
Measurement of the number and size of GAD(+) brain lesions from baseline to post-dosing 8 days after initiation of treatment
Time Frame
From initial dose through 8 days after initiation of dosing
Secondary Outcome Measure Information:
Title
Changes in the ability of patients to complete a timed 25-foot walk
Description
To determine changes in timed 25 foot walk prior to treatment or 8 days after treatment
Time Frame
From initial dosing through 8 days post-initiation of dosing
Title
Treatment-induced changes in Expanded Disability Status Score in patients
Description
Measurement of Expanded Disability Status scores in patients prior to treatment and after completion of treatment
Time Frame
Prior to initial dose through 8 days post-initial treatment
Title
Changes in neurological exam
Description
Neurological examination of patients to check for optic nerve changes and vision changes
Time Frame
Prior to initial dose through 8 days post-initial treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stuart Cook, MD
Phone
(201) 213-5052
Email
cookstu@comcast.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart Cook, MD
Organizational Affiliation
VA Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Magnetic Resonance Imaging Study of JM-4 in Multiple Sclerosis/Clinically Patients
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