Obese Children and Adolescents Clinical Trial
Official title:
Topiramate and Severe Obesity in Children and Adolescents
The purpose of this study is to evaluate the efficacy of Topiramate on the decrease of Body Mass Index compared to placebo at 9 months.
Childhood obesity remains through adulthood in main cases, and is associated with an early
increase of cardiovascular risk and an excess mortality in young adults due to stroke and
cancer.
Bariatric surgery is very rare in France for children and can cause severe complications.
Long term effects are still unknown.
Topiramate is already use in thousands of children in neurology, its effects are already well
known, and no lethal complication is reported.
The hypothesis is that Topiramate associated with standard treatment of obesity is more
effective than standard treatment alone.
This will be a 4.5-years, randomized, double-blind, placebo-controlled, clinical trial of
topiramate (9 months) vs placebo (9months) for Body Mass Index reduction in 160 adolescents
(ages 9-17 years old) with severe obesity.
The main objective is to evaluate the efficacy of Topiramate on the decrease of Body Mass
Index compared to placebo at 9 months.
The secondary objectives are to evaluate:
- the decrease of Body Mass Index Z-score
- the tolerance of Topiramate
- the effectiveness of Topiramate on weight decrease and decrease of Body Mass Index and
Body Mass Index Z-score at 1, 3 ,4 and 6 months
- the effectiveness of Topiramate on eating behaviour, physical activity, calculated with
validated questionnaires and scales at 6 and 9 months
- the pharmacokinetic of Topiramate in obese children and adolescents
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT06205563 -
The Therapeutic Effect of Different Exercise Intensities on Weight Loss in Obese Children
|
N/A |