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Obese Children and AdolescentsPhase 3TOBINCT02273804

Topiramate and Severe Obesity

A Phase 3 study testing Topiramate in people with Obese Children and Adolescents, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 9 to 17 years
Conditions the study is for
Obese Children and Adolescents
What is being tested?
Topiramate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
18 participants
Where
1 siteFrance
Study dates
1 Jun 2016to 23 Jan 2018
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 9 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 19Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

France1 site

  • Hopital Bicêtre

    Le Kremlin-Bicêtre, Paris, 94275

Other trials in France

About this study

Official title: Topiramate and Severe Obesity in Children and Adolescents

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
Being tested
Topiramate, Placebo
Keywords
Topiramate, Obesity, Children, Adolescents
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TopiramateDrug

    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.

  • PlaceboDrug

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

Study groups in NCT02273804
Study groupRoleWhat they receive
topiramateExperimentalpill
Receives: Drug: Topiramate
placeboPlacebo comparatorSugar pill
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Success is defined by a percent change > 2.5%

    Measured: 9 months

Secondary outcomes (14)

  1. Adverse event outcome

    Measured: Up to 4,5 years of follow-up

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

    Measured: 9 months

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

    Measured: 1 months

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

    Measured: 3 months

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

    Measured: 4 months

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

    Measured: 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

    Measured: 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

    Measured: 9 months

  9. Physical activity

    Questionnaire from French Ministry of Health

    Measured: 6 months

  10. Physical activity

    Questionnaire from French Ministry of Health

    Measured: 9 months

  11. Food intake

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

    Measured: 6 months

  12. Food intake

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

    Measured: 9 months

  13. Comorbidity outcome

    Comorbidities and metabolic and cardiorespiratory complications

    Measured: 6 months

  14. Comorbidity outcome

    Comorbidities and metabolic and cardiorespiratory complications

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2014 (estimated)
  2. Study start1 Jun 2016
  3. Primary completion21 Dec 2017
  4. Study completion23 Jan 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02273804
Sponsor's protocol ID
P091122
Other IDs
2011-006193-36
Acronym
TOBI
Status last verified
Dec 2025
First submitted
22 Oct 2014
Last updated
11 Dec 2025
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Topiramate in people with Obese Children and Adolescents, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change from Baseline in Body Mass Index (BMI) (time frame: 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02273804, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.

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