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New treatment option for ALS (Amyotrophic Lateral Sclerosis)
Official title A Study of LY4256984 in Participants With Sporadic Amyotrophic Lateral Sclerosis
ClinicalTrials.gov ID: NCT07100119
What this study is testing
What is LY4256984?
LY4256984 is an investigational medicine, being studied as a potential treatment for als (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 purpose of this study is to evaluate how well LY4256984 is tolerated and what side effects may occur in participants with sporadic amyotrophic lateral sclerosis (ALS). The study drug will be administered intrathecally (IT) into the spine.
- 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 75
You may be able to join if
- Have a definite, possible, or probable diagnosis of sporadic amyotrophic lateral sclerosis (ALS) made by a physician experienced with the management...
- ALS symptom onset as determined by the Investigator within 24 months of Screening
- Have a body mass index (BMI) within the range of greater than or equal to 18.0 and less than or equal to 35.0 kilogram per square meter (kg/m²)...
You likely can't join if
- Have a history or presence of medical illness including, but not limited to, any cardiovascular, renal, hepatic, gastrointestinal, respiratory...
- Have a history of another neurodegenerative disease or significant dementia/severe cognitive problems
- Have serum alanine aminotransferase (ALT), aspartate transferase (AST), or total bilirubin levels greater than 2 x upper limit of normal.
- Have a significant renal impairment (estimated glomerular filtration rate \<60 milliliters per minute [mL/min]/1.73 m²).
- Have a 12-lead electrocardiogram (ECG) abnormality at screening, in the opinion of the investigator, that increases the risks associated with...
- Show clinically significant abnormalities in lumbar spine previously known or determined by screening lumbar X-ray or fluoroscopy (if performed)
The study team makes the final eligibility decision.
Where it's taking place
- Leuven, Belgium
- Calgary, Canada
- Edmonton, Canada
- 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 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leuven, Belgium; Calgary, Canada; Edmonton, Canada; London, Canada; Montreal, Canada; Toronto, Canada and 6 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.