HEALEY ALS Platform Trial - Regimen B Verdiperstat

Study 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 B will evaluate the safety and efficacy of a single study drug, verdiperstat, in participants with ALS.

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Familial ALS,  Sporadic ALS

Study Type:

Interventional Trial

Study Category:

Drug Trial

Study Status:

Not yet enrolling

Phase:

Phase II, Phase III

Study Chair(s)/Principal Investigator(s):

Merit Cudkowicz, MD Massachusetts General Hospital

Clinicaltrials.gov ID (11 digit #):

NCT04436510

Neals Affiliated?

Yes

Coordinating Center Contact Information

Healey Center for ALS at Massachusetts General Hospital
Platform Trial Research Navigator / .(JavaScript must be enabled to view this email address) / 833-425-8257
.(JavaScript must be enabled to view this email address) Boston, Massachusetts United States

Full Study 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. 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 B - Verdiperstat, the participant will complete a screening visit to assess additional Regimen B eligibility criteria. Once Regimen B eligibility criteria are confirmed, participants will complete a baseline assessment and be randomized in a 3:1 ratio to either active Verdiperstat or matching placebo.

Regimen B will enroll by invitation as participants may not choose to enroll in Regimen B. 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 B.

For a list of enrolling sites, please see the HEALEY ALS Platform Trial Master Protocol under NCT04297683.

Study Sponsor:

Merit E. Cudkowicz, MD

Participant Duration:

Estimated Enrollment:

160

Estimated Study Start Date:

06/30/2020

Estimated Study Completion Date:

09/30/2021

Posting Last Modified Date:

07/14/2020

Date Study Added to alsconsortium.org:

07/06/2020
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  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    N/A

    Time since Symptom Onset:

    Time since Diagnosis:

    Can participants use Riluzole?

    Yes


    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. Participants who are taking strong inhibitors of CYP1A2 (i.e., ciprofloxacin, enoxacin, fluvoxamine, zafirlukast) for chronic/long-term use defined as more than two weeks.
    2. Participants who are taking strong inhibitors of CYP3A4 (i.e., conivaptan, itraconazole, ketoconazole, posaconazole, troleandomycin, voriconazole, clarithromycin, diltiazem, idelalisib, nefazodone, and certain antiviral agents [cobicistat, danoprevir, ritonavir, elvitegravir, indinavir, lopinavir, paritaprevir, ombitasavir, dasabuvir, saquinavir, tipranavir, nelfinavir]) for chronic/long-term use defined as more than two weeks. Note: Topical antifungal use is not exclusionary. Participants should not consume large quantities of grapefruit juice (more than 8oz per day) on a regular basis.

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