ALS master protocol with LY4256984 in eligible completers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a master protocol that supports multiple sub-studies sharing core design elements and enrolled ALS patients who completed a qualifying parent trial. Participants are assigned to a specific sub-study (OL01) based on the parent study they completed. The main goal in these sub-studies is to assess safety and tolerability of LY4256984 over a period of at least 96 weeks. The design allows for collection of safety data across related ALS interventions within a common framework.

Why it matters

Who can join: the full rules

Participants must meet eligibility criteria below. Additional criteria are specified in the substudy to which the participant will enroll.

Inclusion Criteria:

* Have completed an eligible parent study, as determined by the investigator. Eligible parent studies will be defined by the sponsor but will be clinical studies designed to evaluate a study intervention for the treatment of ALS.

  * Note 1: To be considered a "completer" of a parent study, the participant must finish the main treatment period/phase of the parent study as well as any off-treatment period/phase as described in the parent study's protocol.
  * Note 2: Visits missed in a parent study will have no impact on the completer status of a potential participant.

Exclusion Criteria:

* During the parent study, the participant permanently or temporarily discontinued the investigational medicinal product (IMP), such that restarting the IMP would pose an unacceptable risk to the participant's safety, in the opinion of the investigator.
* During the parent study, the participant experienced extreme ALS disease progression (for example, permanent mechanical ventilation) that poses an unacceptable risk to the participant's safety in the opinion of the investigator.
* During the parent study, the participant developed an unresolved SAE or a medical illness (other than ALS) that, in the opinion of the investigator, precludes either continued exposure to an IMP or participation in study procedures due to an unacceptable risk to the participant's safety.

Where it's running

• McGill University Health Centre
  Montreal, Canada Recruiting
• Sunnybrook Research Institute
  Toronto, Canada Recruiting
• UZ Leuven
  Leuven, Belgium Not yet recruiting
• Heritage Medical Research Clinic
  Calgary, Canada Not yet recruiting
• University Hospital - London Health Sciences Centre
  London, Canada Not yet recruiting
• Universitätsklinikum Schleswig-Holstein
  Lübeck, Germany Not yet recruiting

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 1-317-615-4559

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.