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

NCT07221292

This study is recruiting at 3 US sites in 3 states, according to its ClinicalTrials.gov record last updated .

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

  • CACNA1A
  • Spinocerebellar Ataxia Type 6
  • Episodic Ataxia Type 2
  • Familial Hemiplegic Migraine-1

Eligibility basics and study details

Study type
Interventional
Phase
Phase 3
Ages
4 years and older
Sex
All
Healthy volunteers
Not accepted
Sponsor
IntraBio Inc
Last updated on ClinicalTrials.gov
September 8, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites

Maryland · 1

  • Johns Hopkins University · Baltimore, MD

Massachusetts · 1

  • Massachusetts General Hospital · Boston, MA

Texas · 1

  • The University of Texas Health (UT Health) · Houston, TX

Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.