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Topiramate and Severe Obesity (TOBI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02273804
Recruitment Status : Completed
First Posted : October 24, 2014
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Obese Children and Adolescents Drug: Topiramate Drug: Placebo Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Topiramate and Severe Obesity in Children and Adolescents
Actual Study Start Date : June 1, 2016
Actual Primary Completion Date : December 21, 2017
Actual Study Completion Date : January 23, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Topiramate

Arm Intervention/treatment
Experimental: topiramate
pill
Drug: Topiramate
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.

Placebo Comparator: placebo
Sugar pill
Drug: Placebo
Placebo will be taken orally following to the same dose regimen according to theoretical weight




Primary Outcome Measures :
  1. Percent Change from Baseline in Body Mass Index (BMI) [ Time Frame: 9 months ]
    Success is defined by a percent change > 2.5%


Secondary Outcome Measures :
  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 [ Time Frame: 6 months ]

    Self-administered questionnaires and scales :

    Binge Eating Scale ; State trait anxiety Inventory for Children; Child depression inventory, Child Behavior Checklist


  8. Eating Behaviour [ Time Frame: 9 months ]

    Self-administered questionnaires and scales :

    Binge Eating Scale ; State trait anxiety Inventory for Children; Child depression inventory; Child Behavior Checklist


  9. Physical activity [ Time Frame: 6 months ]
    Questionnaire from French Ministry of Health

  10. Physical activity [ Time Frame: 9 months ]
    Questionnaire from French Ministry of Health

  11. Food intake [ Time Frame: 6 months ]
    High-fat, sugary, salted food intake and beverage other than drinking water

  12. Food intake [ Time Frame: 9 months ]
    High-fat, sugary, salted food intake and beverage other than drinking water

  13. Comorbidity outcome [ Time Frame: 6 months ]
    Comorbidities and metabolic and cardiorespiratory complications

  14. Comorbidity outcome [ Time Frame: 9 months ]
    Comorbidities and metabolic and cardiorespiratory complications



Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02273804


Locations
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France
Hopital Bicêtre
Le Kremlin-Bicêtre, Paris, France, 94275
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Study Chair: Marie-Laure Frelut, MD Assistance Publique - Hôpitaux de Paris
Principal Investigator: Gianpaolo De Filippo, MD, PhD Assistance Publique - Hôpitaux de Paris

Publications:
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02273804    
Other Study ID Numbers: P091122
2011-006193-36 ( EudraCT Number )
First Posted: October 24, 2014    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Topiramate
Obesity
Children
Adolescents
Additional relevant MeSH terms:
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Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Topiramate
Anticonvulsants
Hypoglycemic Agents
Physiological Effects of Drugs