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New treatment option for Amyotrophic Lateral Sclerosis
Official title A Substudy of LY4256984 in Participants With Sporadic Amyotrophic Lateral Sclerosis
ClinicalTrials.gov ID: NCT07571174
What this study is testing
What is LY4256984?
LY4256984 is an investigational medicine, being studied as a potential treatment for amyotrophic lateral sclerosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The main purpose of this study is to assess the long-term safety and tolerability of LY4256984 in participants with Amyotrophic Lateral Sclerosis (ALS). This study is a long-term extension of study J6I-MC-OWAA (NCT07100119) and is part of the OLMP (NCT07571200) master protocol that will last approximately 96 weeks.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Participants must meet eligibility criteria in the [L0U-MC-OLMP] screening protocol before entry into the treatment study.
- Have completed the main treatment period/phase as well as any off-treatment period/phase of Study OWAA, the parent study for this ISA.
You likely can't join if
- 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...
- 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...
- Currently receiving treatment with an anticoagulant, antiplatelet agent, or other drug that affects coagulation or platelet function. Low dose...
The study team makes the final eligibility decision.
Where it's taking place
- Leuven, Belgium
- London, Canada
- Montreal, Canada
- Toronto, Canada
- Lübeck, Germany
- Rostock, Germany
- Ulm, Germany
- Utrecht, Netherlands
- L'Hospitalet de Llobregat, Spain
- Valencia, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leuven, Belgium; London, Canada; Montreal, Canada; Toronto, Canada; Lübeck, Germany; Rostock, Germany and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.