31P-MRS Imaging to Assess the Effects of CNM-Au8 on Impaired Neuronal Redox State in Multiple Sclerosis. (REPAIR-MS)
Multiple Sclerosis
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring neurodegeneration, gold, nanoparticle, NAD+, redox, 31P-MRS, multiple sclerosis, magnetic resonance spectroscopy, nanocrystal, NADH, primary progressive multiple sclerosis, relapsing multiple sclerosis
Eligibility Criteria
Inclusion Criteria:
- At least 18 years of age and up to 70 years (inclusive) of age at Screening.
- Diagnosis of primary progressive multiple sclerosis (PPMS) or nonactive secondary progressive multiple sclerosis (SPMS), according to revised 2017 McDonald criteria at the Screening visit;
- EDSS score at the Screening visit of less than or equal to 6.5 (inclusive);
- Participants must be taking either B-cell depleting therapy (e.g., ocrelizumab, rituximab) or S1P modulator therapy (e.g., siponimod) with consistent stable dosing for at least 48 weeks prior to the Screening visit;
- 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; and
- Able to understand and give written informed consent.
Exclusion Criteria:
- History of MS relapses or gadolinium-enhancing lesions seen on brain MRI scans within the five (5) years prior to the Screening visit.
- History of AQP4, MOG Ab(+) status, or documented ≥ 3 contiguous segment lesion in the spinal cord.
- Any diagnosis other than PPMS or SPMS that could explain a participant's signs and symptoms.
- Participants taking any MS disease-modifying therapy other than Bcell depleting therapy (e.g., ocrelizumab, rituximab) or S1P modulator therapy (e.g., siponimod), or not taking diseasemodifying therapy.
- 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.
- 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 ≥500 eosinophils per microliter) at Screening.
- 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).
- Positive screen for drugs of abuse or known alcohol abuse.
- Females who are pregnant, have a positive pregnancy test, are nursing, or who plan to get pregnant during the course of this clinical trial or within 6 months of the end of this trial.
- Women of child-bearing potential, or men, who are unwilling or unable to use accepted methods of birth control during the study and for 6 months following completion of study participation.
- Patients with implanted metal objects in their body that may be affected by an MRI procedure.
- Patients who are claustrophobic or otherwise unlikely to be able to complete the MRI scanning procedures.
- Patients with a history of gold allergy.
- Patient is considered a suicide risk in the opinion of the Investigator, has previously made a suicide attempt, or is currently demonstrating active suicidal ideation. Subjects with intermittent passive suicidal ideation are not necessarily excluded based on the assessment of the Investigator.
Sites / Locations
- University of Texas SouthwesternRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
7.5mg CNM-Au8
15mg CNM-Au8
30mg CNM-Au8
60mg CNM-Au8
7.5mg suspension of clean-surfaced, faceted, gold nanocrystals in 120ml of sodium bicarbonate buffered water
15mg suspension of clean-surfaced, faceted, gold nanocrystals in 120ml of sodium bicarbonate buffered water
30mg suspension of clean-surfaced, faceted, gold nanocrystals in 120ml of sodium bicarbonate buffered water
60mg suspension of clean-surfaced, faceted, gold nanocrystals in 120ml of sodium bicarbonate buffered water