Phase
Condition
Multiple Sclerosis
Memory Loss
Neurologic Disorders
Treatment
CNM-Au8
Clinical Study ID
Ages 18-55 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Participants must have completed study CNMAu8.201.
- Able to understand and give written informed consent.
Exclusion
Exclusion Criteria:
- Lack of treatment compliance during participation in the CNMAu8.201 (VISIONARY-MS)study.
- Positive pregnancy test.
- Any history of previous malignancy, with the exception of basal cell carcinoma of theskin or in situ carcinoma of the cervix, post documented full resections, with cleanmargins.
- Based on the Investigator's judgment, any concurrent chronic or acute illness orunstable medical condition that could confound the results of safety assessments,increase risk to the participant, or lead to difficulty complying with the protocol;any untreated or unstable psychiatric disease including depression, bipolar andpsychosis.
- Participant is considered a suicide risk in the opinion of the Investigator, haspreviously made a suicide attempt, or is currently demonstrating active suicidalideation. Following clinical and serology sample analysis conducted at the end-of-study visit forCNMAu8.201 (VISIONARY-MS), participants may be removed from this long term extension studyif any of the following criteria are met, at the discretion of the Medical Monitor and/orSponsor's Medical Representative:
- Positive serology for viral hepatitis B and/or C and/or human immunodeficiency virus (HIV).
- Abnormal liver function tests (aspartate aminotransferase [ASAT] or alanineaminotransferase [ALAT] > 2x upper limit of normal range (ULN) or total bilirubin > 2xULN or alkaline phosphatase (AP) > 3x ULN).
- Participants with clinically significant hepatic or renal dysfunction or clinicallaboratory findings that would limit the interpretability of change in liver or kidneyfunction (e.g., glomerular filtration rate < 40 mL/min [based on creatinine clearanceaccording to Cockcroft-Gault equation]), or those with low platelet counts (<150 x 109per liter) or eosinophilia (absolute eosinophil count of ≥500 eosinophils permicroliter) at the EOS visit for CNMAu8.201 (Visionary-MS).
Study Design
Study Description
Connect with a study center
Sydney Brain Mind Centre
Camperdown, New South Wales 2050
AustraliaSite Not Available
Royal North Shore Hospital
Leonards Hill, New South Wales 2065
AustraliaSite Not Available
John Hunter Hospital
New Lambton Heights, New South Wales 2305
AustraliaSite Not Available
Westmead Hospital
Westmead, New South Wales 2145
AustraliaSite Not Available
Princess Alexandra Hospital
Woolloongabba, Queensland 4102
AustraliaSite Not Available
Menzies Institute for Medical Research
Hobart, TAZ 7000
AustraliaSite Not Available
Lyell McEwin Hospital
Elizabeth, Vale 5112
AustraliaSite Not Available
Austin Health Department of Neurology
Heidelberg, Victoria 3084
AustraliaSite Not Available
The Alfred Centre Department of Neuroscience
Melbourne, Victoria 3004
AustraliaSite Not Available
The Royal Melbourne Hospital
Parkville, Victoria 3050
AustraliaSite Not Available
The Perron Institute
Nedlands, Western Australia 6009
AustraliaSite Not Available
University of British Columbia
Vancouver, British Columbia V6T 1Z3
CanadaSite Not Available
University of Texas Southwestern Medical Center
Dallas, Texas 75390
United StatesSite Not Available
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