drugset / Trial / NCT03843710
31P-MRS Imaging to Assess the Effects of CNM-Au8 on Impaired Neuronal Redox State in Amyotrophic Lateral Sclerosis (REPAIR-ALS)
Non-randomizedSequentialOpen-labelTreatment
Summary
REPAIR-ALS is a single-center open label pilot, 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 Amyotrophic Lateral Sclerosis (ALS) within twelve (12) months of Screening. The primary endpoint is the ratio of the oxidized to reduced form of nicotinamide adenine dinucleotide (NAD+:NADH) measured non-invasively by 31phosphorous magnetic resonance spectroscopy (31P-MRS).
Timeline
- Start
- 2020-03
- Primary completion
- 2022-02
- Completion
- 2022-03
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 |