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NCT01141595 · ClinicalTrials.gov registry record · NA
Tetrahydrobiopterin Treatment in Children With Idiopathic Cognitive Developmental Disorders
A NA study, sponsored by The University of Texas Health Science Center, Houston.
- Completed
- Registry status
- NA
- Development phase
- 10
- Enrollment target
NCT01141595: Completed NA study, sponsored by The University of Texas Health Science Center, Houston.
NCT01141595 is a NA study that has completed, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 10 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01141595, a NA study, has completed, sponsored by The University of Texas Health Science Center, Houston.
- COMPLETED
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
Study Summary
The purpose of this study is to develop biomarkers for central nervous system BH4 concentration in children with autism so they can be easily screened to determine if they may benefit from BH4 supplementation. Kuvan is a synthetic form of BH4. BH4 is an enzyme cofactor that is essential for several critical metabolic functions.
Primary Outcome
Change in the raw score from baseline of the Preschool Language Scales over the 16 week period. The raw score was measured at baseline, 8 weeks and 16 weeks after starting treatment and the change over the 16 week period from baseline to the end of the study was calculated. There was no imputed data and the analysis was as treated. The raw score ranged from 0 to 130. Higher scores indicate better performance.
Interventions
- DRUG sapropterin dihydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2010-07 |
| Est. Completion | 2011-09 |
| Phase | NA |
What the finished NCT01141595 record still lists
NCT01141595 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which sapropterin dihydrochloride is the first listed.
NCT01141595 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01141595 about?
NCT01141595 is a clinical study titled "Tetrahydrobiopterin Treatment in Children With Idiopathic Cognitive Developmental Disorders". The purpose of this study is to develop biomarkers for central nervous system BH4 concentration in children with autism so they can be easily screened to determine if they may benefit from BH4 supplementation. Kuvan is a synthetic form of BH4. BH4 is an enzyme cofactor that is essential for several ...
What is the current status of trial NCT01141595?
This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2010-07. Estimated completion is 2011-09.
What interventions are being tested in trial NCT01141595?
The interventions under investigation include: sapropterin dihydrochloride (DRUG).
Who is sponsoring clinical trial NCT01141595?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01141595's enrollment target sits among peer trials
10 1927th of 2000 higher than 26 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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