Clinical Trial

Pivotal Study of N-acetyl-L-leucine for CACNA1A

Not Yet Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 1 change
notable Trial sites expanded: 5 -> 10 locations 2026-06-05
Trial Details
NCT Number NCT07221292
Lead Sponsor IntraBio Inc
Conditions CACNA1A, Spinocerebellar Ataxia Type 6, Episodic Ataxia Type 2, Familial Hemiplegic Migraine-1
Enrollment 60 participants
Start Date 2026-09-01
Primary Completion 2027-08-01 (estimated)
Study Completion 2028-11-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-04