drugset / Trial / NCT03993171
31P-MRS Imaging to Assess the Effects of CNM-Au8 on Impaired Neuronal Redox State in Multiple Sclerosis.
Phase 2
Completed
33 enrolled
Clene Nanomedicine
University of Texas Southwestern Medical Center · collab
Non-randomizedSequentialOpen-labelTreatment
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.
Timeline
- Start
- 2019-12-19
- Primary completion
- 2025-05-27
- Completion
- 2025-07-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CNM-Au8 | Other / unclassified | 7.5 mg | Oral |
| Subject | CNM-Au8 | Other / unclassified | 15 mg | Oral |
| Subject | CNM-Au8 | Other / unclassified | 30 mg | Oral |
| Subject | CNM-Au8 | Other / unclassified | 60 mg | Oral |