U.S., Dec. 18 -- ClinicalTrials.gov registry received information related to the study (NCT07287397) titled 'Study is to Assess the Safety and Tolerability of VTx-002 in Participants With ALS' on Nov. 19.
Brief Summary: PIONEER-ALS is a Phase 1/2, multicenter, open-label, ascending dose, uncontrolled, first-in-human study that will evaluate the safety, tolerability and effects on clinical and biomarker endpoints of intracisternal administration of Vtx-002 in participants with Amyotrophic Lateral Sclerosis (ALS).
Two escalating dose (low dose and high dose) cohorts are planned. The duration of the study will be a maximum of 5 years and 5 weeks (265 weeks) for each participant. The screening period may last up to 5 weeks to complete screeni...