Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2026-05-16 @ 1:09 AM
Study NCT ID:
NCT02273804
Status:
COMPLETED
Last Update Posted:
2025-12-11
First Post:
2014-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Topiramate and Severe Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077236', 'term': 'Topiramate'}], 'ancestors': [{'id': 'D005632', 'term': 'Fructose'}, {'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D007661', 'term': 'Ketoses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2014-10-22', 'studyFirstSubmitQcDate': '2014-10-22', 'lastUpdatePostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change from Baseline in Body Mass Index (BMI)', 'timeFrame': '9 months', 'description': 'Success is defined by a percent change \\> 2.5%'}], 'secondaryOutcomes': [{'measure': 'Adverse event outcome', 'timeFrame': 'Up to 4,5 years of follow-up'}, {'measure': 'Percent Change from Baseline in Body Mass Index Z-score', 'timeFrame': '9 months'}, {'measure': 'Percent Change from Baseline in Body Mass Index and Body Mass Index Z-score', 'timeFrame': '1 months'}, {'measure': 'Percent Change from Baseline in Body Mass Index and Body Mass Index Z-score', 'timeFrame': '3 months'}, {'measure': 'Percent Change from Baseline in Body Mass Index and Body Mass Index Z-score', 'timeFrame': '4 months'}, {'measure': 'Percent Change from Baseline in Body Mass Index and Body Mass Index Z-score', 'timeFrame': '6 months'}, {'measure': 'Eating Behaviour', 'timeFrame': '6 months', 'description': 'Self-administered questionnaires and scales :\n\nBinge Eating Scale ; State trait anxiety Inventory for Children; Child depression inventory, Child Behavior Checklist'}, {'measure': 'Eating Behaviour', 'timeFrame': '9 months', 'description': 'Self-administered questionnaires and scales :\n\nBinge Eating Scale ; State trait anxiety Inventory for Children; Child depression inventory; Child Behavior Checklist'}, {'measure': 'Physical activity', 'timeFrame': '6 months', 'description': 'Questionnaire from French Ministry of Health'}, {'measure': 'Physical activity', 'timeFrame': '9 months', 'description': 'Questionnaire from French Ministry of Health'}, {'measure': 'Food intake', 'timeFrame': '6 months', 'description': 'High-fat, sugary, salted food intake and beverage other than drinking water'}, {'measure': 'Food intake', 'timeFrame': '9 months', 'description': 'High-fat, sugary, salted food intake and beverage other than drinking water'}, {'measure': 'Comorbidity outcome', 'timeFrame': '6 months', 'description': 'Comorbidities and metabolic and cardiorespiratory complications'}, {'measure': 'Comorbidity outcome', 'timeFrame': '9 months', 'description': 'Comorbidities and metabolic and cardiorespiratory complications'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Topiramate', 'Obesity', 'Children', 'Adolescents'], 'conditions': ['Obese Children and Adolescents']}, 'referencesModule': {'references': [{'pmid': '18782881', 'type': 'BACKGROUND', 'citation': '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': '14711062', 'type': 'BACKGROUND', 'citation': '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': '15536230', 'type': 'BACKGROUND', 'citation': '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': '16703004', 'type': 'BACKGROUND', 'citation': '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': '17363756', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nBariatric surgery is very rare in France for children and can cause severe complications. Long term effects are still unknown.\n\nTopiramate is already use in thousands of children in neurology, its effects are already well known, and no lethal complication is reported.\n\nThe hypothesis is that Topiramate associated with standard treatment of obesity is more effective than standard treatment alone.\n\nThis 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.\n\nThe main objective is to evaluate the efficacy of Topiramate on the decrease of Body Mass Index compared to placebo at 9 months.\n\nThe secondary objectives are to evaluate:\n\n* the decrease of Body Mass Index Z-score\n* the tolerance of Topiramate\n* 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\n* the effectiveness of Topiramate on eating behaviour, physical activity, calculated with validated questionnaires and scales at 6 and 9 months\n* the pharmacokinetic of Topiramate in obese children and adolescents'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '9 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 9-17 years old\n* Body Mass Index Z-score ≥ 4 SD of French reference\n* Weight at enrolment ≥ 50 kg\n* Therapeutic failure \\> 6 months\n* For girls of childbearing age, willing to have an acceptable method of contraception (no estrogens plus progestin)\n* Negative pregnancy test for girls of childbearing age\n* Agreeing to participate upon written informed consent\n* Appropriate understanding of the study\n\nExclusion Criteria:\n\n* Syndromic or secondary obesity\n* Major neurological or psychiatric disorder\n* Current or history of suicidal thought/attempts\n* Current or history of breakdown\n* Previous bariatric surgery\n* Severe hypercapnia\n* Renal dysfunction\n* Deformity in the urinary tract or solitary kidney\n* History of renal lithiasis or glaucoma\n* Poorly controlled diabetic children or adolescents (HbA1c \\>10%) and diabetic patients treated with Metformine and/or glibenclamide\n* Hepatic dysfunction\n* Bicarbonate ≤16 mmol/L\n* Known hypersensitivity to the active substance or to one of the excipients\n* Intolerance to saccharose\n* Enrolment in another therapeutic study\n* High probability to fail to comply with treatment\n* Females: Pregnant, planning to become pregnant\n* No signature on consent form\n* Uncovered by the French National health Insurance system (Sécurité sociale)'}, 'identificationModule': {'nctId': 'NCT02273804', 'acronym': 'TOBI', 'briefTitle': 'Topiramate and Severe Obesity', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Topiramate and Severe Obesity in Children and Adolescents', 'orgStudyIdInfo': {'id': 'P091122'}, 'secondaryIdInfos': [{'id': '2011-006193-36', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'topiramate', 'description': 'pill', 'interventionNames': ['Drug: Topiramate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'Sugar pill', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Topiramate', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['topiramate']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo will be taken orally following to the same dose regimen according to theoretical weight', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94275', 'city': 'Le Kremlin-Bicêtre', 'state': 'Paris', 'country': 'France', 'facility': 'Hopital Bicêtre', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}], 'overallOfficials': [{'name': 'Marie-Laure Frelut, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}, {'name': 'Gianpaolo De Filippo, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'URC-CIC Paris Descartes Necker Cochin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}