Status: Not yet recruiting
Pivotal Study of N-acetyl-L-leucine for CACNA1A
A pivotal, randomized, double-blind, placebo-controlled, multi-center therapeutic study for patients age 4 and older with a confirmed diagnosis of CACNA1A. The objective of this study is to evaluate the safety, tolerability and efficacy of N-acetyl-L-leucine (IB1001) compared to standard of care.
Participants needed: 60
Trial details
Phase: Phase 3Age: 4+Biological sex: AllType: InterventionalSponsor: IntraBio IncUpdated: Jun 4, 2026Locations: 10
Eligibility criteria
Written informed consent signed by the patient and/or their legal representative... [+19]
Acetyl-Leucine (DL-, L-, D-) or derivatives. [+14]