Long-term safety test of LY4256984 in ALS patients

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 Phase 1 extension focused on long-term safety and tolerability of LY4256984 in participants with sporadic ALS. It follows the main study OWAA under the OLMP master protocol and is expected to last about 96 weeks. The trial involves ongoing administration of LY4256984 and monitoring for adverse events, lab results, and procedures such as lumbar puncture as needed. Eligibility requires completion of the parent study and the absence of contraindications to LP and related criteria. The study is conducted at select centers, led by Eli Lilly and Company.

Why it matters

Who can join: the full rules

Participants must meet eligibility criteria in the \[L0U-MC-OLMP\] screening protocol before entry into the treatment study.

Inclusion Criteria:

* Have completed the main treatment period/phase as well as any off-treatment period/phase of Study OWAA, the parent study for this ISA.

Exclusion Criteria:

* The participant has conditions that preclude a lumbar puncture (LP), such as:

  * A history of clinically significant back pain, back pathology, and/or back injury (for example, degenerative disease, spinal deformity, or spinal surgery) that may predispose to complications or technical difficulty with LP.
  * Allergy to local anesthetics, such as lidocaine or its derivatives.
  * A local infection at the intended site of the LP.
  * Less than 100 giga per liter \[(\<100 GI/L) is equivalent to 100,000 per cubic millimeter (100,000/mm³)\] platelets or clinically significant coagulation abnormality or significant active bleeding, or
  * Currently receiving treatment with an anticoagulant, antiplatelet agent, or other drug that affects coagulation or platelet function. Low dose (according to local medical guidelines) aspirin is permitted.

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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Implanted Brain-Computer Interface to Help People with Severe Arm Impairment

  We’re testing the N1 System, a fully implanted brain interface in the motor cortex with a robot, to see if it can help adults with spinal cord injury, ALS, or chronic stroke use a computer or keyboard more easily.

  Recruiting Neuralink Corp · Miami, Florida · NCT07929792

• Brain-computer interface chat tool for people with ALS

  This test compares a wearable brain-computer interface communication device to eye-tracking devices that people with ALS currently use to help them communicate.

  Recruiting Cognixion · Santa Barbara, California · NCT07871071

• BIIB147 safety and how it behaves in adults with ALS

  This study tests BIIB147 in adults with ALS to see if it is safe and how the body handles it, including early and long-term effects.

  Recruiting at 2 sites Phase 1/2 Biogen · St Louis, Missouri and 1 other locations · NCT07855211

• Aims to restore UNC13A function in people with ALS

  This trial tests TRCN-1023 in adults with ALS to see if it’s safe, tolerated, and shows early signs of benefit.

  Recruiting at 6 sites Phase 1/2 Trace Neuroscience, Inc. · Lübeck, Schleswig-Holstein and 5 other locations · NCT07674667

• LTX-002 in adults with ALS

  A study will test whether the experimental drug LTX-002 is safe and tolerable in adults with ALS and see how the body handles the drug and how it affects ALS indicators.

  Recruiting at 4 sites Phase 1/2 Leal Therapeutics, Inc · Lübeck and 4 other locations · NCT07660614

• Repeated ultrasound-assisted blood-brain barrier opening in ALS

  This trial tests whether repeatedly opening the blood-brain barrier with ultrasound is safe and may help people with ALS.

  Recruiting Phase 1/2 Assistance Publique - Hôpitaux de Paris · Paris · NCT07571486

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.