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NCT01773278 · ClinicalTrials.gov registry record · Phase 2
Cholesterol and Antioxidant Treatment in Patients With Smith-Lemli-Opitz Syndrome (SLOS)
A Phase 2 study of Hearing Loss and Smith-Lemli-Opitz Syndrome, sponsored by University of Colorado, Denver.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT01773278 is a Phase 2 study of Hearing Loss and Smith-Lemli-Opitz Syndrome that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 100 participants, below the 6,119-participant average among 58 other Hearing Loss trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01773278, a Phase 2 study of Hearing Loss and Smith-Lemli-Opitz Syndrome, is actively recruiting participants, sponsored by University of Colorado, Denver.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
Patients with biochemically confirmed SLOS are being treated with cholesterol supplementation and antioxidant medication. They are carefully monitored with visits to clinic, laboratory testing including cholesterol and 7-dehydrocholesterol levels, vitamin levels, blood counts and liver and kidney function. On a serial basis, no more often than once a year, the patients undergo a series of tests under anesthesia, including electroretinogram (ERG), brainstem audiometry (ABR), and ophthalmologic exam under anesthesia to follow pigmentary retinopathy.
Conditions Studied
Interventions
- DRUG Antioxidants
- DRUG Cholesterol
Study Locations (1)
Colorado
- Children's Hospital Colorado - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2008-12 |
| Est. Completion | 2025-12 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01773278
The ClinicalTrials.gov registry entry for NCT01773278 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 6,119-participant average among 58 other Hearing Loss trials with a reported enrollment target (98% lower). The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Hearing Loss appearing as the primary indexed condition, and to 2 interventions - of which Antioxidants is the first listed.
NCT01773278 reports 1 study location spanning 1 distinct geographic area - top geographies include Colorado.
Frequently Asked Questions
What is clinical trial NCT01773278 about?
NCT01773278 is a clinical study titled "Cholesterol and Antioxidant Treatment in Patients With Smith-Lemli-Opitz Syndrome (SLOS)". Patients with biochemically confirmed SLOS are being treated with cholesterol supplementation and antioxidant medication. They are carefully monitored with visits to clinic, laboratory testing including cholesterol and 7-dehydrocholesterol levels, vitamin levels, blood counts and liver and kidney fu...
What is the current status of trial NCT01773278?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2008-12. Estimated completion is 2025-12.
What conditions does trial NCT01773278 study?
This clinical trial studies the following conditions: Hearing Loss, Smith-Lemli-Opitz Syndrome, Cone-Rod Dystrophy.
What interventions are being tested in trial NCT01773278?
The interventions under investigation include: Antioxidants (DRUG), Cholesterol (DRUG).
Who is sponsoring clinical trial NCT01773278?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01773278 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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