Micaela C Morgado, Mónica Sousa, André B Coelho, Susana Vale, Júlio A Costa, André Seabra
Effects of "Football and Nutrition for Health" program on body composition, physical fitness, eating behaviours, nutritional knowledge, and psychological status among 7 to 10 years school children
Frontiers in pediatrics
dravet syndrome rare early childhoodonset epileptic developmental encephalopathy responses placebo clinical trials epilepsy therapies range widely factors influencing placebo response remain poorly understood study explored placebo response effects safety efficacy quality life outcomes patients dravet syndrome performed exploratory posthoc analyses pooled data placebotreated patients gwpcare 1b gwpcare 2 randomized controlled phase iii trials comparing cannabidiol matched placebo 218 year old dravet syndrome patients patients 4 convulsive seizures baseline period 4 weeks 124 dravet syndrometreated patients included analysis 25 years n 35 612 years n 52 1318 years n 37 convulsive seizures experienced placebo group patients timepoints decreased median convulsive seizure frequency treatment period versus baseline number convulsive seizurefree days similar baseline convulsive seizure frequency nominally significant positive correlation age nominally significant negative correlation body mass index placebotreated patients experienced treatmentemergent adverse event however resolved quickly serious adverse events infrequent placebo treatment little effect reported caregiver global impression change outcomes versus baseline placebo little impact convulsive seizurefree days caregiver global impression change versus baseline suggesting metrics may help differentiate placebo active treatment effects future studies however future research assess placebo responses confirm results