CompletedPhase 2/3

HEALEY ALS Platform Trial - Regimen G DNL343

United States249 participantsStarted 2023-05-24

Plain-language summary

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.

Who can participate

Age range18 Years – 100 Years

SexALL

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Exclusion criteria

✕. 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.

What they're measuring

Disease Progression as Assessed by the ALSFRS-R-Slope

Timeframe: Baseline to 24 Weeks

Mortality Event Rate

Timeframe: Baseline to 24 weeks

Trial details

NCT IDNCT05842941

SponsorMerit E. Cudkowicz, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-29

Results submitted2025-10-22

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