HEALEY ALS Platform Trial - Regimen G DNL343
Amyotrophic Lateral Sclerosis
About this trial
This is an interventional treatment trial for Amyotrophic Lateral Sclerosis focused on measuring ALS, Placebo-Controlled, Double-Blind, Regimen Specific Appendix, Lou Gehrig's Disease, DNL343, Denali Therapeutics
Eligibility Criteria
Inclusion Criteria: No additional inclusion criteria beyond the inclusion criteria specified in the Master Protocol (NCT NCT04297683). Exclusion Criteria: The following exclusion criteria are in addition to the exclusion criteria specified in the Master Protocol (NCT NCT04297683). Diagnosis of epilepsy or seizure within 6 months of randomization Hypersensitivity to DNL343 or any of the excipients contained within the DNL343 drug product The concomitant use of prescription or over-the-counter (OTC) medications that are inducers of certain cytochrome P450 enzymes, substrates of certain cytochrome P450 enzymes, or substrates of certain drug transporters.
Sites / Locations
- Healey Center for ALS at Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
DNL343
Matching Placebo