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

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

Key facts

Study ID

NCT05740813

Run by

Merit E. Cudkowicz, MD

People needed

310

Starts

2023-03-23

Expected to finish

2024-10-03

Last updated by the study team

2025-11-14

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).
• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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