NCT01954693.

Trial name or title	A study of everolimus in the treatment of neurocognitive problems in tuberous sclerosis (TRON).
Methods	Single centre, 2‐arm, individually randomised, phase II, double‐blind, placebo‐controlled study.
Participants	People aged 16 to 60 years with TSC who have IQ > 60 and a significant deficit in one or more primary outcome measures.
Interventions	Participants are randomised into either: 1. placebo tablet OR 2. everolimus tablet (2 x 2.5mg daily).
Outcomes	Primary outcomes: list Learning test (from the BIRT Memory and Information Processing Battery); complex Figure test (from the BIRT Memory and Information Processing Battery); CANTAB ‐ Stockings of Cambridge (SOC); CANTAB ‐ Spatial Working Memory (SWM); telephone search dual task (from the Test of Everyday Attention). Secondary outcomes: CANTAB ‐ Rapid Visual Information Processing Battery (RVIP); CANTAB ‐ Spatial Span (SSP); CANTAB ‐ Attentional Set‐shifting (IDED); Verbal Fluency /Controlled Oral Word Association Test (COWAT); cancellation task; Symptom Checklist 90R (SCL‐90R); QoL in Epilepsy (QOLIE); Liverpool Seizure Severity Scale (LSSS); Vineland Adaptive Behavior Scales‐II (VABS‐II) (survey form); Social Responsiveness Scale ‐ Adult version (SRS‐A); Social communication questionnaire (SCQ); National Adult Reading Test (NART). Other outcomes: Wechsler Abbreviated Scale of Intelligence (WASI) (4 subtests) (eligibility visit screening measure); Edinburgh Handedness Test (eligibility visit screening measures).
Starting date	June 2012.
Contact information	Prof. Julia Sampson. Email: sampson@cardiff.ac.uk.
Notes	Sponsored by Cardiff University in collaboration with Novartis.