Status:
COMPLETED
Topiramate and Severe Obesity
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
URC-CIC Paris Descartes Necker Cochin
Conditions:
Obese Children and Adolescents
Eligibility:
All Genders
9-17 years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 23 2018
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT02273804
Start Date
June 1 2016
End Date
January 23 2018
Last Update
December 11 2025
Active Locations (1)
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1
Hopital Bicêtre
Le Kremlin-Bicêtre, Paris, France, 94275