drugset / Trial / NCT01773278

Cholesterol and Antioxidant Treatment in Patients With Smith-Lemli-Opitz Syndrome (SLOS)

NCT01773278

Phase 2 Unknown 100 enrolled University of Colorado, Denver
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2008-12
Primary completion
2025-12
Completion
2025-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Cholesterol Small molecule
Subject DEKAS plus Other / unclassified