Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Efficacy of RAD001/Everolimus in Autism and NeuroPsychological Deficits in Children With Tuberous Sclerosis Complex
Brief Summary: Tuberous sclerosis complex (TSC) is a genetic disease that leads to mental retardation in over 50% of patients, and to learning problems, behavioral problems, autism and epilepsy in up to 90% of patients. The underlying deficit of TSC, loss of inhibition of the mammalian target of rapamycin (mTOR) protein due to dysfunction of the tuberin/hamartin protein complex, can be rescued by everolimus. Everolimus has been registered as treatment for renal cell carcinoma and giant cell astrocytoma (SEGA). Evidence in human and animal studies suggests that mTOR inhibitors improve learning and development in patients with TSC.


Options:
A: Arm Label: Everolimus; Type: EXPERIMENTAL; Interventions: Drug: Everolimus | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Everolimus; Assigned to Arm(s): Everolimus | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
B: Arm Label: Everolimus LT target of 3 - 7 ng/mL; Type: EXPERIMENTAL; Interventions: Drug: RAD001, Drug: Antiepileptic drug (1 to 3 only), Drug: open label RAD001 (only used for post-extension phase) | Arm Label: Everolimus HT target of 9 -15 ng/mL; Type: EXPERIMENTAL; Interventions: Drug: RAD001, Drug: Antiepileptic drug (1 to 3 only), Drug: open label RAD001 (only used for post-extension phase) | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo, Drug: Antiepileptic drug (1 to 3 only), Drug: open label RAD001 (only used for post-extension phase) | Intervention Type: DRUG; Name: RAD001; Assigned to Arm(s): Everolimus HT target of 9 -15 ng/mL, Everolimus LT target of 3 - 7 ng/mL | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: Antiepileptic drug (1 to 3 only); Assigned to Arm(s): Everolimus HT target of 9 -15 ng/mL, Everolimus LT target of 3 - 7 ng/mL, Placebo | Intervention Type: DRUG; Name: open label RAD001 (only used for post-extension phase); Assigned to Arm(s): Everolimus HT target of 9 -15 ng/mL, Everolimus LT target of 3 - 7 ng/mL, Placebo
C: Arm Label: TSC Placebo Arm; Type: PLACEBO_COMPARATOR; Interventions: Drug: Skincerity | Arm Label: TSC 1% Arm; Type: EXPERIMENTAL; Interventions: Drug: Skincerity plus sirolimus/rapamycin | Arm Label: TSC 5% Arm; Type: EXPERIMENTAL; Interventions: Drug: Skinercity plus sirolimus/rapamycin | Arm Label: NF1 Placebo Arm; Type: PLACEBO_COMPARATOR; Interventions: Drug: Skincerity | Arm Label: NF1 1% Arm; Type: EXPERIMENTAL; Interventions: Drug: Skincerity plus sirolimus/rapamycin | Arm Label: NF1 5% Arm; Type: EXPERIMENTAL; Interventions: Drug: Skinercity plus sirolimus/rapamycin | Intervention Type: DRUG; Name: Skincerity; Assigned to Arm(s): NF1 Placebo Arm, TSC Placebo Arm | Intervention Type: DRUG; Name: Skincerity plus sirolimus/rapamycin; Assigned to Arm(s): NF1 1% Arm, TSC 1% Arm | Intervention Type: DRUG; Name: Skinercity plus sirolimus/rapamycin; Assigned to Arm(s): NF1 5% Arm, TSC 5% Arm
D: Intervention Type: DRUG; Name: sirolimus; Assigned to Arm(s): N/A

Answer: A