Topiramate and Severe Obesity (TOBI)

Assistance Publique - Hôpitaux de Paris

Status and phase: Completed; Phase 3

Conditions: Obese Children and Adolescents

Treatments: Drug: Topiramate; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02273804

P091122

2011-006193-36 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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

Enrollment: 18 patients

Sex: All

Ages: 9 to 17 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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18 participants in 2 patient groups, including a placebo group

topiramate

Experimental group

Description:

pill

Treatment:

Drug: Topiramate

placebo

Placebo Comparator group

Description:

Sugar pill

Treatment:

Drug: Placebo