A Master Protocol (OLMP): A Study of LY4256984 in Participants With Amyotrophic Lateral Sclerosis (ALS)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LY4256984.
- Who it may be relevant to
- Registry conditions: Amyotrophic Lateral Sclerosis. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium, Canada, Germany, Netherlands, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Master Protocol for Open-Label Extension Studies to Evaluate the Long-Term Safety and Tolerability of Interventions in Various Stages of Clinical Development in Participants With Amyotrophic Lateral Sclerosis
Overview
Study OLMP is a master protocol that will support a collection of individual sub studies that share key design components. Participants from the originator study OWAA (NCT07100119) will be assigned to the appropriate study treatment group: Sporadic Amyotrophic Lateral Sclerosis OL01 (NCT07571174). The studies aim to evaluate the safety and tolerability of different treatments in participants with Amyotrophic Lateral Sclerosis (ALS) that will last at least 96 weeks.
Interventions
- Drug LY4256984
Administered IT
Primary outcome measures
- Number of Participants Allocated to Each of the Intervention-Specific Appendices (ISA) [Time frame: Baseline Up to Week 96]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Screening
Study locations
Canada · 3 centers
- University Hospital - London Health Sciences Centre — London
- McGill University Health Centre — Montreal
- Sunnybrook Research Institute — Toronto
Germany · 3 centers
- Universitätsklinikum Schleswig-Holstein — Lübeck
- Universitätsmedizin Rostock — Rostock
- Universitaetsklinikum Ulm — Ulm
Spain · 2 centers
- Hospital Universitari de Bellvitge — L'Hospitalet de Llobregat
- Hospital Universitari i Politecnic La Fe — Valencia
Belgium · 1 center
- UZ Leuven — Leuven
Netherlands · 1 center
- Universitair Medisch Centrum Utrecht — Utrecht
Identifiers
NCT: NCT07571200 · 27888 · L0U-MC-OLMP · L0U-MC-OL01 · 2026-525574-19-00