Topiramate and Severe Obesity

NCT02273804 | Completed Phase 3 DMC

• 2 other identifiers: P0911222011-006193-36
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Obese Children and Adolescents

Keywords

Topiramate; Obesity; Children; Adolescents

Outcome Measures

Primary Outcomes (1)

• Percent Change from Baseline in Body Mass Index (BMI)

  Success is defined by a percent change \> 2.5%

  9 months

Secondary Outcomes (14)

• Adverse event outcome

  Up to 4,5 years of follow-up

• Percent Change from Baseline in Body Mass Index Z-score

  9 months

• Percent Change from Baseline in Body Mass Index and Body Mass Index Z-score

  1 months

• Percent Change from Baseline in Body Mass Index and Body Mass Index Z-score

  3 months

• Percent Change from Baseline in Body Mass Index and Body Mass Index Z-score

  4 months

Study Arms (2)

topiramate

EXPERIMENTAL

pill

Drug: Topiramate

placebo

PLACEBO COMPARATOR

Sugar pill

Drug: Placebo

Interventions

Topiramate DRUG

Topiramate for 9 months treatment, and then 27 months of follow-up Dose regimen will be determined according to theoretical weight (taken orally), escalated every 15 days. Patients who do not tolerate dose escalation will be reduced to the highest tolerated dose.

topiramate

Placebo DRUG

Placebo will be taken orally following to the same dose regimen according to theoretical weight

placebo

Eligibility Criteria

• Age: 9 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hopital Bicêtre

Le Kremlin-Bicêtre, Paris, 94275, France

Location

Related Publications (5)

• McGovern L, Johnson JN, Paulo R, Hettinger A, Singhal V, Kamath C, Erwin PJ, Montori VM. Clinical review: treatment of pediatric obesity: a systematic review and meta-analysis of randomized trials. J Clin Endocrinol Metab. 2008 Dec;93(12):4600-5. doi: 10.1210/jc.2006-2409. Epub 2008 Sep 9.

  PMID: 18782881 BACKGROUND

• Bray GA. Risks of obesity. Endocrinol Metab Clin North Am. 2003 Dec;32(4):787-804, viii. doi: 10.1016/s0889-8529(03)00067-7.

  PMID: 14711062 BACKGROUND

• Astrup A, Caterson I, Zelissen P, Guy-Grand B, Carruba M, Levy B, Sun X, Fitchet M. Topiramate: long-term maintenance of weight loss induced by a low-calorie diet in obese subjects. Obes Res. 2004 Oct;12(10):1658-69. doi: 10.1038/oby.2004.206.

  PMID: 15536230 BACKGROUND

• Toplak H, Hamann A, Moore R, Masson E, Gorska M, Vercruysse F, Sun X, Fitchet M. Efficacy and safety of topiramate in combination with metformin in the treatment of obese subjects with type 2 diabetes: a randomized, double-blind, placebo-controlled study. Int J Obes (Lond). 2007 Jan;31(1):138-46. doi: 10.1038/sj.ijo.0803382. Epub 2006 May 16.

  PMID: 16703004 BACKGROUND

• Rosenstock J, Hollander P, Gadde KM, Sun X, Strauss R, Leung A; OBD-202 Study Group. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of topiramate controlled release in the treatment of obese type 2 diabetic patients. Diabetes Care. 2007 Jun;30(6):1480-6. doi: 10.2337/dc06-2001. Epub 2007 Mar 15.

  PMID: 17363756 BACKGROUND

MeSH Terms

Conditions

Obesity

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Study Officials

• Marie-Laure Frelut, MD

  Assistance Publique - Hôpitaux de Paris

  STUDY CHAIR

• Gianpaolo De Filippo, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2014
• First Posted: October 24, 2014
• Study Start: June 1, 2016
• Primary Completion: December 21, 2017
• Study Completion: January 23, 2018
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)