Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Clinical Trial Phase 3 study, sponsored by IntraBio.
NCT07221292 is a Phase 3 study that has not yet begun recruiting, run by IntraBio. The registered enrollment target is 60 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The Scale for Assessment and Rating of Ataxia has 8 items that are related to gait, stance, sitting, speech, finger-chase test, nose-finger test, fast alternating movements, and heel-shin test. The range is 0-40 points, with a lower score representing neurological improvement and a higher score representing neurological worsening.
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 |
What is known before NCT07221292 opens enrollment
NCT07221292 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT07221292 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07221292's enrollment target sits among peer trials
60 1804th of 2000 higher than 177 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00576069 · 60 participants
Mechanism(s)of Airflow Limitation in Moderate-severe Persistent Asthma
- NCT01297400 · 60 participants · Phase 2
Phase 2 Pilot Study of the Safety and Efficacy of Topical MW-III in Thermal Burns
- NCT01734122 · 60 participants
Stereotactic Radiosurgery for Essential Tremor and Parkinsonian Tremor
- NCT01804634 · 60 participants · Phase 2
Reduced Intensity Haploidentical BMT for High Risk Solid Tumors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI