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Quick Info
Status
Currently Recruiting
Phase
2/ 3
Trial Type
Interventional
Treatment Type
Drug Trials
Randomization
3:1
Enrollment
240
Start Date
3/1/2023 (anticipated)
Contact Information
    Contact information unknown.
Locations
Enrollment Criteria
Breathing Ability
Percent lung function (FVC) or (SVC)
≥ 50%
Months Since Onset
Number of months since first symptoms of ALS.
<36 months
Non-Invasive Ventilation (NIV)
Can PALS use a BiPAP in the trial?
Yes
Diaphragm Pacer (DPS)
Can PALS use a DPS in the trial?
Yes
Edaravone Usage
Can a PALS use edaravone (Radicut/Radicava) while enrolled in the trial?
Yes
Open Label
Yes
Update Notes
There are no update notes for this clinical trial.

Other Information

Purpose
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.
Eligibility
Inclusion Criteria:
- No additional inclusion criteria beyond the inclusion criteria specified in the Master Protocol (NCT NCT04297683).
Exclusion Criteria:
- The following exclusion criteria are in addition to the exclusion criteria specified in the Master Protocol (NCT NCT04297683).
1. Based on the metabolism of the compound, the concomitant use of certain inhibitors and inducers of cytochrome P450 enzymes.
2. Any clinically significant ECG abnormalities.
3. Clinically significant clinical laboratory abnormalities.
Details
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. This trial is designed as a perpetual platform trial. This means that there is a single Master Protocol dictating the conduct of the trial. The HEALEY ALS Platform Trial Master Protocol is registered as NCT04297683. Once a participant enrolls into the Master Protocol and meets all eligibility criteria, the participant will be eligible to be randomized into any currently enrolling regimen. All participants will have an equal chance of being randomized to any currently enrolling regimen. If a participant is randomized to Regimen F ABBV-CLS-7262, the participant will complete a screening visit to assess additional Regimen F eligibility criteria. Once Regimen F eligibility criteria are confirmed, participants will complete a baseline assessment and be randomized in a 3:1 ratio to either active ABBV-CLS-7262 or matching placebo. Regimen F will enroll by invitation, as participants may not choose to enroll in Regimen F. Participants must first enroll into the Master Protocol and be eligible to participate in the Master Protocol before being able to be randomly assigned to Regimen F. For a list of enrolling sites, please see the HEALEY ALS Platform Trial Master Protocol under NCT04297683.
Collaborator(s)
  • Merit E. Cudkowicz, MD
Trial Protocol as Published on Clinicaltrials.gov
NCT05740813 (First Published: 2/12/2023)