HEALEY ALS Platform Trial - Regimen G DNL343

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Amyotrophic Lateral Sclerosis

In brief

The HEALEY ALS Platform Trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS. Regimen G will evaluate the safety and efficacy of a single study drug, DNL343, in participants with ALS.

Key facts

Study ID

NCT05842941

Run by

Merit E. Cudkowicz, MD

People needed

249

Starts

2023-05-24

Expected to finish

2024-10-29

Last updated by the study team

2026-01-28

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• No additional inclusion criteria beyond the inclusion criteria specified in the Master Protocol (NCT NCT04297683).

You may not qualify if…

• 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.

Where it is running

• Healey Center for ALS at Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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