At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 10 enrolled
Drug / intervention
Sirolimusdrug
Likely dose
Low-dose oral sirolimus (specific dose not stated)AI-extracted
Key inclusion· 9
- ✓Age 3 to 31 years
- ✓Cognitive impairment documented by SWS cognitive neuroscore ≥1
- ✓Able to participate in direct neuropsychological and developmental testing
- ✓English as primary language
Key exclusion· 16
- ✕Allergy to sirolimus or other rapamycin analogues
- ✕Seizures secondary to metabolic, toxic, infectious, or psychogenic disorder; drug abuse; or acute medical illness
- ✕Unable to keep follow-up appointments or maintain close contact with investigators
- ✕Need for immediate major surgical intervention
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Trial of Sirolimus for Cognitive Impairment in Sturge-Weber Syndrome
In Brief
A Phase 3 clinical trial evaluating Sirolimus for Sturge-Weber Syndrome. Completed, enrolled 10 participants across 2 sites.
Detailed Summary
The purpose of this research study is to gain a preliminary understanding of the safety of sirolimus in Sturge-Weber syndrome (SWS) and determine best outcomes to be used to assess the utility of sirolimus for the treatment of cognitive impairments related to Sturge-Weber syndrome.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSturge-Weber Syndrome
CountriesUnited States
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartJan 2017
First PostedFeb 2017
Primary CompletionJun 2019
Study CompletionOct 2020
TodayJul 2026
First PostedFeb 9, 2017
Enrollment StartJan 1, 2017
Primary CompletionJun 4, 2019
Study CompletionOct 27, 2020
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 9.4 years ago
Interventions
Sirolimusdrug
Low dose oral sirolimus