Topiramate and Severe Obesity

Assistance Publique - Hôpitaux de Paris18 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Obese Children and Adolescents

Interventions

TopiramateDRUG

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.

PlaceboDRUG

Placebo will be taken orally following to the same dose regimen according to theoretical weight

Eligibility

Sex: ALLMin age: 9 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 9-17 years old * Body Mass Index Z-score ≥ 4 SD of French reference * Weight at enrolment ≥ 50 kg * Therapeutic failure \> 6 months * For girls of childbearing age, willing to have an acceptable method of contraception (no estrogens plus progestin) * Negative pregnancy test for girls of childbearing age * Agreeing to participate upon written informed consent * Appropriate understanding of the study Exclusion Criteria: * Syndromic or secondary obesity * Major neurological or psychiatric disorder * Current or history of suicidal thought/attempts * Current or history of breakdown * Previous bariatric surgery * Severe hypercapnia * Renal dysfunction * Deformity in the urinary tract or solitary kidney * History of renal lithiasis or glaucoma * Poorly controlled diabetic children or adolescents (HbA1c \>10%) and diabetic patients treated with Metformine and/or glibenclamide * Hepatic dysfunction * Bicarbonate ≤16 mmol/L * Known hypersensitivity to the active substance or to one of the excipients * Intolerance to saccharose * Enrolment in another therapeutic study * High probability to fail to comply with treatment * Females: Pregnant, planning to become pregnant * No signature on consent form * Uncovered by the French National health Insurance system (Sécurité sociale)

Locations (1)

Hopital Bicêtre

Le Kremlin-Bicêtre, Paris, France

Outcomes

Primary Outcomes

Percent Change from Baseline in Body Mass Index (BMI)

Success is defined by a percent change \> 2.5%

Time frame: 9 months

Secondary Outcomes

Adverse event outcome

Time frame: Up to 4,5 years of follow-up

Percent Change from Baseline in Body Mass Index Z-score

Time frame: 9 months

Percent Change from Baseline in Body Mass Index and Body Mass Index Z-score

Time frame: 1 months

Percent Change from Baseline in Body Mass Index and Body Mass Index Z-score

Time frame: 3 months

Percent Change from Baseline in Body Mass Index and Body Mass Index Z-score

Time frame: 4 months

Percent Change from Baseline in Body Mass Index and Body Mass Index Z-score

Time frame: 6 months

Eating Behaviour

Self-administered questionnaires and scales : Binge Eating Scale ; State trait anxiety Inventory for Children; Child depression inventory, Child Behavior Checklist

Time frame: 6 months

Eating Behaviour

Self-administered questionnaires and scales : Binge Eating Scale ; State trait anxiety Inventory for Children; Child depression inventory; Child Behavior Checklist

Time frame: 9 months

Physical activity

Data from ClinicalTrials.gov

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