Trial Outcomes & Findings for SLOS: The Effect of Simvastatin in Patients Receiving Cholesterol Supplementation (NCT NCT01434745)
NCT ID: NCT01434745
Last Updated: 2019-10-01
Results Overview
neurocognitive assessment measured with Mullen Scales of Learning
TERMINATED
NA
1 participants
through study completion, an average of 2 per year
2019-10-01
Participant Flow
Only one participant enrolled
Participant milestones
| Measure |
Placebo - Lactose
Placebo-Lactose
Lactose: Lactose will be administered in a capsule formula.
|
Simvastatin
0.5 mg/kg body weight/day
Simvastatin: Simvastatin will be administered as a powder mixed with lactose at the dose of 0.5 mg/kg/day
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
SLOS: The Effect of Simvastatin in Patients Receiving Cholesterol Supplementation
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: through study completion, an average of 2 per yearPopulation: No funding
neurocognitive assessment measured with Mullen Scales of Learning
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: end of treatment, an average of 1 per yearPopulation: Analyses were not completed and will never be completed due to insufficient funding
administration of cholesterol and water labeled with stable isotope followed by measurement overtime in blood concentrations
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: through study completion, an average of 2 per yearPopulation: Analyses were not completed and will never be completed due to insufficient funding
Blood cholesterol to 7-dehydrocholesterol ratio
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: end of treatment, an average of 1 per yearPopulation: Analyses were not completed and will never be completed due to insufficient funding
Apparent diffusion coefficient measured by brain diffusion tensor imaging (DTI)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: through study completion, an average of 2 per yearPopulation: Analyses were not completed and will never be completed due to insufficient funding
urinary mevalonate excretion
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: end of treatment, an average of 1 per yearPopulation: Analyses were not completed and will never be completed due to insufficient funding
Brain magnetic resonance spectroscopy
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: end of treatment, an average of 1 per yearPopulation: Analyses were not completed and will never be completed due to insufficient funding
Fractional anisotropy as measured by brain diffusion tensor imaging (DTI)
Outcome measures
Outcome data not reported
Adverse Events
Placebo - Lactose
Simvastatin
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place