Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2025-12-24 @ 3:15 PM
NCT ID:
NCT00064792
Eligibility Criteria:
* INCLUSION CRITERIA:
All patients with biochemically proven SLOS will be considered for this study.
EXCLUSION CRITERIA:
Patients will be excluded if they cannot travel to the NIH because of their medical condition.
Age less than 4 and older than 18.
Weight less than 10 kg.
Developmental delay too severe to obtain adequate behavioral evaluation.
Severe behavioral problems that preclude proper physical and laboratory medicine evaluation.
SLOS severity score greater than 30.
No biochemical diagnosis of SLOS.
No molecular conformation of SLOS.
Residual fibroblasts enzymatic activity less than 10% of control value (cholesterol synthesis as a fraction of total sterol synthesis).
Dehydrocholesterol/cholesterol ratio greater than 1.0.
Renal insufficiency.
Contraindications for simvastatin use:
History of hypersensitivity to simvastatin or other "statins."
Acute liver disease.
Persistent elevations of serum transaminase levels or persistent elevations of CPK.
Concomitant therapy with tetralol-class calcium channel blockers (such as mibefradil).
Pregnancy or lactation.
History of rhabdomyolysis or myopathy.
Concomitant therapy with other drugs associated with myopathy (such as gemfibrozil or other fibrates, niacin) or metabolism by the P450 isoform 3A4 system (such as cyclosporin, itraconazole, ketoconazole, macrolide antibiotics, or nefazodone (Serzone)).
Warfarin-type anticoagulant therapy.
Severe cataracts.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
18 Years
Study:
NCT00064792
Study Brief:
Protocol Section:
NCT00064792