31P-MRS Imaging to Assess the Effects of CNM-Au8 on Impaired Neuronal Redox State in Multiple Scl… (NCT03993171) | Clinical Trial Compass
CompletedPhase 2
31P-MRS Imaging to Assess the Effects of CNM-Au8 on Impaired Neuronal Redox State in Multiple Sclerosis.
United States33 participantsStarted 2019-12-19
Plain-language summary
REPAIR-MS is a single-center open label, sequential group, investigator and patient blinded study to assess the CNS metabolic effects, safety, pharmacokinetics, and pharmacodynamics of CNM-Au8 in patients who have been diagnosed with Multiple Sclerosis (MS) within fifteen (15) years of Screening. The primary endpoint for this study changes from baseline to week 12 in CNS metabolic changes, based on 31P-MRSimaging.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. At least 18 years of age and up to 55 years (inclusive) of age at Screening.
✓. Diagnosis of MS no longer than 15 years prior to Screening.
✓. Stable treatment with natalizumab, defined as a stable dose maintained at the standard infusion interval of 28-days (±5 days) for at least the prior six (6) months.
✓. Stable disease activity based on the Investigator's judgment over the prior three (3) months.
✓. Any hematological parameters and/or biochemical parameters that fall outside the Within Normal Limits range at Screening must be assessed as Not Clinically Significant (NCS) and deemed stable or transient in nature.
✓. Able to understand and give written informed consent.
✓. Male or female, aged 18 - 70 years or age (inclusive);
Exclusion criteria
✕. Patients with a clinical relapse requiring systemic steroid treatment within the prior three (3) months.
✕. Patients treated with any other MS therapy other than natalizumab; or treated with clemastine fumarate.
✕. Based on the Investigator's judgment, patients with a history of significant other major medical condition that may interfere with the conduct of the study or interpretation of the study results.
What they're measuring
1
The change from baseline to week 12 in CNS metabolic changes, based on 31P-MRS Redox Ratio.
✕. Based on the Investigator's judgment, patients who may have difficulty complying with the protocol and/or study procedures.
✕. History of any clinically significant abnormality in hematology, blood chemistry, ECG, or physical examination not resolved by the Baseline visit which according to Investigator can interfere with study participation.
✕. Patients with clinically significant hepatic or renal dysfunction or clinical laboratory findings that would limit the interpretability of change in liver or kidney function, or those with low platelet counts (\< 150 x 109 per liter) or eosinophilia (absolute eosinophil count of
✕. Patients with a prior history of, or positive serological assay for the presence of HIV infection, or laboratory evidence of active or chronic infection with hepatitis C (HCV) or hepatitis B (HBV). Note, participants who have been vaccinated for HBV and have detectable HB antibodies are not excluded unless positive for hepatitis surface antigen (HBsAg).
✕. Patients participating in any other investigational drug trial or using an investigational drug (within 12 weeks prior to screening and thereafter).