CompletedPhase 2/3

HEALEY ALS Platform Trial - Regimen F ABBV-CLS-7262

United States310 participantsStarted 2023-03-23

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 F will evaluate the safety and efficacy of a single study drug, ABBV-CLS-7262, in participants with ALS.

Who can participate

Age range18 Years – 100 Years

SexALL

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Exclusion criteria

✕. Based on the metabolism of the compound, the concomitant use of certain inhibitors and inducers of cytochrome P450 enzymes.
✕. Any clinically significant ECG abnormalities.
✕. Clinically significant clinical laboratory abnormalities.

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 IDNCT05740813

SponsorMerit E. Cudkowicz, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-03

Results submitted2025-10-01

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