Topiramate and Severe Obesity
- Registration Number
- NCT02273804
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Brief 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo Placebo Sugar pill topiramate Topiramate pill
- Primary Outcome Measures
Name Time Method Percent Change from Baseline in Body Mass Index (BMI) 9 months Success is defined by a percent change \> 2.5%
- Secondary Outcome Measures
Name Time Method Percent Change from Baseline in Body Mass Index Z-score 9 months Adverse event outcome Up to 4,5 years of follow-up Percent Change from Baseline in Body Mass Index and Body Mass Index Z-score 6 months Eating Behaviour 9 months Self-administered questionnaires and scales :
Binge Eating Scale ; State trait anxiety Inventory for Children; Child depression inventory; Child Behavior ChecklistPhysical activity 9 months Questionnaire from French Ministry of Health
Comorbidity outcome 9 months Comorbidities and metabolic and cardiorespiratory complications
Food intake 9 months High-fat, sugary, salted food intake and beverage other than drinking water
Trial Locations
- Locations (1)
Hopital Bicêtre
🇫🇷Le Kremlin-Bicêtre, Paris, France