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CompletedNCT02273804TOBIUpdated Dec 11, 2025

Topiramate and Severe Obesity

A Phase 3 interventional study of Topiramate and Placebo in Obese Children and Adolescents, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 9 Years to 17 Years. Per ClinicalTrials.gov, last updated 2025-12-11.

Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
9 Years to 17 Years
Sex
All
01

Study 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.

Read the 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 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
02

Conditions studied

  • Obese Children and Adolescents

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Keywords

  • Topiramate
  • Obesity
  • Children
  • Adolescents
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,695 are open to participants now.

This study's enrollment of 18 is below the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
9 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
18 participants (actual)

Study arms

  • Experimental
    topiramate

    pill

    Drug: Topiramate

  • Placebo comparator
    placebo

    Sugar pill

    Drug: Placebo

Interventions

  • DrugTopiramate

    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.

  • DrugPlacebo

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

06

What researchers measure

Primary outcomes

  1. Percent Change from Baseline in Body Mass Index (BMI)

    Success is defined by a percent change \> 2.5%

    Time frame: 9 months

Secondary outcomes

  1. Adverse event outcome

    Time frame: Up to 4,5 years of follow-up

  2. Percent Change from Baseline in Body Mass Index Z-score

    Time frame: 9 months

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

    Time frame: 1 months

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

    Time frame: 3 months

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

    Time frame: 4 months

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

    Time frame: 6 months

  7. Eating Behaviour

    Self-administered questionnaires and scales : Binge Eating Scale ; State trait anxiety Inventory for Children; Child depression inventory, Child Behavior Checklist

    Time frame: 6 months

  8. Eating Behaviour

    Self-administered questionnaires and scales : Binge Eating Scale ; State trait anxiety Inventory for Children; Child depression inventory; Child Behavior Checklist

    Time frame: 9 months

  9. Physical activity

    Questionnaire from French Ministry of Health

    Time frame: 6 months

  10. Physical activity

    Questionnaire from French Ministry of Health

    Time frame: 9 months

  11. Food intake

    High-fat, sugary, salted food intake and beverage other than drinking water

    Time frame: 6 months

  12. Food intake

    High-fat, sugary, salted food intake and beverage other than drinking water

    Time frame: 9 months

  13. Comorbidity outcome

    Comorbidities and metabolic and cardiorespiratory complications

    Time frame: 6 months

  14. Comorbidity outcome

    Comorbidities and metabolic and cardiorespiratory complications

    Time frame: 9 months

07

Study locations

1 site
  • Hopital Bicêtre
    Le Kremlin-Bicêtre, Paris 94275, France
08

References and documents

Publications

  • 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. PubMed 18782881 ↗
  • 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. PubMed 14711062 ↗
  • 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. PubMed 15536230 ↗
  • 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. PubMed 16703004 ↗
  • 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. PubMed 17363756 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02273804
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
URC-CIC Paris Descartes Necker Cochin
Responsible party
Sponsor
First posted
Oct 24, 2014
Start date
Jun 1, 2016
Primary completion
Dec 21, 2017
Completion
Jan 23, 2018
Last update
Dec 11, 2025

Study contacts

Marie-Laure Frelut, MD
study chair · Assistance Publique - Hôpitaux de Paris
Gianpaolo De Filippo, MD, PhD
principal investigator · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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