A Phase 2, Open-Label, Sequential Group, Investigator Blinded Study of Magnetic Resonance Spectroscopy (31P-MRS) to Assess the Effects of CNM-Au8 for the Bioenergetic Improvement of Impaired Neuronal Redox State in Multiple Sclerosis.

Who is this study for? Patients with Multiple Sclerosis, Fatigue
What treatments are being studied? Gold Nanocrystals
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: No
View:

• 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.

Locations
United States
Texas
University of Texas Southwestern
Recruiting
Dallas
Contact Information
Primary
Robert Glanzman
Robert@clene.com
(801) 676-9695
Backup
Austin Rynders, RN
Austin@clene.com
(801) 676-9695
Time Frame
Start Date: December 19, 2019
Estimated Completion Date: December 2022
Participants
Target number of participants: 30
Treatments
Experimental: 7.5mg CNM-Au8
7.5mg suspension of clean-surfaced, faceted, gold nanocrystals in 120ml of sodium bicarbonate buffered water
Experimental: 15mg CNM-Au8
15mg suspension of clean-surfaced, faceted, gold nanocrystals in 120ml of sodium bicarbonate buffered water
Experimental: 30mg CNM-Au8
30mg suspension of clean-surfaced, faceted, gold nanocrystals in 120ml of sodium bicarbonate buffered water
Experimental: 60mg CNM-Au8
60mg suspension of clean-surfaced, faceted, gold nanocrystals in 120ml of sodium bicarbonate buffered water
Sponsors
Leads: Clene Nanomedicine
Collaborators: University of Texas Southwestern Medical Center

This content was sourced from clinicaltrials.gov

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