NCT02273804

Topiramate and Severe Obesity

Topiramate and Severe Obesity in Children and Adolescents

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 9 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Obese Children and Adolescents

Interventions

Type	Name	Description
DRUG	Topiramate	Topiramate for 9 months treatment, and then 27 months of follow-up Dose regimen will be determined according to theoretical weight (taken orally), escalated every 15 days. Patients who do not tolerate dose escalation will be reduced to the highest tolerated dose.
DRUG	Placebo	Placebo will be taken orally following to the same dose regimen according to theoretical weight

Timeline

• Start date: 2016-06-01
• Primary completion: 2017-12-21
• Completion: 2018-01-23
• First posted: 2014-10-24
• Last updated: 2025-12-11

Locations

1 site across 1 country: France