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. Blood tests will be performed to check how much LY4256984 gets into the bloodstream and how long it takes the body to eliminate it.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
32
UZ Leuven
Leuven, Belgium
NOT_YET_RECRUITINGHeritage Medical Research Clinic
Calgary, Canada
NOT_YET_RECRUITINGNumber of Participants with One or More Treatment Emergent Adverse Events (TEAEs), Serious Adverse Event(s) (SAEs), and Adverse Event(s) (AEs) Considered by the Investigator to be Related to Study Drug Administration
A summary of TEAEs, SAEs, and AEs regardless of causality, will be reported in the Reported Adverse Events module
Time frame: Baseline up to Approximately Day 253
Pharmacokinetics (PK): Plasma Area Under the Concentration Versus Time Curve (AUC) of LY4256984
PK: Plasma AUC of LY4256984
Time frame: Baseline up to Approximately Day 253
PK: Plasma Maximum Concentration (Cmax) of LY4256984
PK: Plasma Cmax of LY4256984
Time frame: Baseline up to Approximately Day 253
PK: Cerebrospinal Fluid Concentrations (CSF) of LY4256984
PK: CSF Concentrations of LY4256984
Time frame: Baseline up to Approximately Day 253
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Walter Mackenzie Health Sciences Centre
Edmonton, Canada
NOT_YET_RECRUITINGLondon Health Sciences Centre
London, Canada
NOT_YET_RECRUITINGMontreal Neurological Institute and Hospital
Montreal, Canada
RECRUITINGSunnybrook Research Institute
Toronto, Canada
RECRUITINGUniversitätsklinikum Schleswig-Holstein
Lübeck, Germany
NOT_YET_RECRUITINGUniversitätsmedizin Rostock Sektion für Translationale Neurodegeneration "Albrecht Kossel" Klinik und Poliklinik für Neurologie
Rostock, Germany
NOT_YET_RECRUITINGUniversitätsklinikum Ulm
Ulm, Germany
NOT_YET_RECRUITINGUniversitair Medisch Centrum Utrecht
Utrecht, Netherlands
RECRUITING...and 2 more locations