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NCT07221292 · ClinicalTrials.gov registry record · Phase 3
Pivotal Study of N-acetyl-L-leucine for CACNA1A
A Phase 3 study, sponsored by IntraBio.
- Not yet
- Registry status
- Phase 3
- Development phase
- 60
- Enrollment target
NCT07221292 is a Phase 3 study that has not yet begun recruiting, run by IntraBio. The registered enrollment target is 60 participants.
The verdict
NCT07221292, a Phase 3 study, has not yet begun recruiting, sponsored by IntraBio.
- NOT YET RECRUITING
- Registry status
- Phase 3
- Development phase
- 60 participants
- Enrollment target
Study 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.
Interventions
- OTHER Placebo
- DRUG N-Acetyl-L-Leucine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2026-09-01 |
| Est. Completion | 2028-11-01 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07221292
The ClinicalTrials.gov registry entry for NCT07221292 describes a study currently listed as not yet recruiting, categorized as Phase 3. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is IntraBio, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT07221292 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07221292 about?
NCT07221292 is a clinical study titled "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.
What is the current status of trial NCT07221292?
This trial is currently not yet recruiting. It is a Phase 3 study. The enrollment target is 60 participants. The study started on 2026-09-01. Estimated completion is 2028-11-01.
What interventions are being tested in trial NCT07221292?
The interventions under investigation include: Placebo (OTHER), N-Acetyl-L-Leucine (DRUG).
Who is sponsoring clinical trial NCT07221292?
This trial is sponsored by IntraBio, which has 6 total clinical trials registered on ClinicalTrials.gov.
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