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NCT05740813CompletedPhase 2/3

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

Source: ClinicalTrials.gov · Last updated 14 Nov 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2/3
Study type
Interventional
Enrollment
310 (actual)
First submitted
12 Feb 2023
Start date
23 Mar 2023
Primary completion date
3 Oct 2024
Lead sponsor
Merit E. Cudkowicz, MD
NCT number
NCT05740813

What you commit to

  • Study type: Interventional · Phase 2/3
  • Participants enrolled: 310
  • From 23 Mar 2023 to the primary completion date, 3 Oct 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Lab values

  • 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.

Who the study is looking for

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

Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Healey Center for ALS at Mass General
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.