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NCT00528268 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate Sodium Phenylbutyrate in Pre-symptomatic Infants With Spinal Muscular Atrophy
A Phase 1 study, sponsored by University of Utah.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
NCT00528268: Completed Phase 1 study, sponsored by University of Utah.
NCT00528268 is a Phase 1 study that has completed, run by University of Utah. The registered enrollment target is 22 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00528268, a Phase 1 study, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
Study Summary
In this single-center trial, we will evaluate the effects of NaPB on presymptomatic Spinal Muscular Atrophy (SMA) type I (cohort 1)and presymptomatic SMA type II (cohort 2) infants. A variety of outcome measures will be performed at each study visit to follow the course of the disease. Total duration of the study for type I infants will be 18 months, for type II infants, 24 months.
Primary Outcome
The number of participants able to achieve specific developmental milestones, such as sitting unsupported or walking independently, during the study period.
Interventions
- DRUG Sodium phenylbutyrate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2007-07 |
| Est. Completion | 2013-12 |
| Phase | Phase 1 |
What the finished NCT00528268 record still lists
NCT00528268 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 1 intervention - of which Sodium phenylbutyrate is the first listed.
NCT00528268 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00528268 about?
NCT00528268 is a clinical study titled "Study to Evaluate Sodium Phenylbutyrate in Pre-symptomatic Infants With Spinal Muscular Atrophy". In this single-center trial, we will evaluate the effects of NaPB on presymptomatic Spinal Muscular Atrophy (SMA) type I (cohort 1)and presymptomatic SMA type II (cohort 2) infants. A variety of outcome measures will be performed at each study visit to follow the course of the disease. Total duratio...
What is the current status of trial NCT00528268?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2007-07. Estimated completion is 2013-12.
What interventions are being tested in trial NCT00528268?
The interventions under investigation include: Sodium phenylbutyrate (DRUG).
Who is sponsoring clinical trial NCT00528268?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00528268's enrollment target sits among peer trials
22 1601st of 2000 higher than 386 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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
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