Topiramate and Severe Obesity

• Status: Completed
• Trial end date: 2018-01-23
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Topiramate

Criteria

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)