Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: TRON: A Randomised, Double Blind, Placebo-controlled Study of RAD001 (Everolimus) in the Treatment of Neurocognitive Problems in Tuberous Sclerosis
Brief Summary: This is a single centre, two-arm, individually randomised, Phase II, double- blind, placebo-controlled trial of RAD001 (Everolimus) versus placebo in the treatment of neurocognitive problems in patients with tuberous sclerosis (TSC). The IMP is a licensed medicine in this patient group but for a different target of effect. The current trial is a proof of principle study for memory and executive function outcomes.

Following an eligibility visit, patients will be scheduled for baseline visit and randomization. They will then be followed up for 6 months undergoing both safety and neurocognitive assessments whilst taking either the placebo or study drug.

48 patients aged 16 to 60 years with tuberous sclerosis (TSC) who have IQ \> 60 and a significant deficit in one or more primary outcome measures will be randomly allocated in a ratio of 2:1 to either RAD001 (Everolimus) or Placebo.


Options:
A: 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
B: Arm Label: Everolimus (RAD001); Type: EXPERIMENTAL; Interventions: Drug: Everolimus (RAD001) | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: Everolimus (RAD001); Assigned to Arm(s): Everolimus (RAD001)
C: 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
D: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: 0.1 % Rapamycin; Type: ACTIVE_COMPARATOR; Interventions: Drug: Rapamycin | Arm Label: 1% Rapamycin; Type: ACTIVE_COMPARATOR; Interventions: Drug: Rapamycin | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: Rapamycin; Assigned to Arm(s): 0.1 % Rapamycin | Intervention Type: DRUG; Name: Rapamycin; Assigned to Arm(s): 1% Rapamycin

Answer: B