Overview

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)