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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-006193-36 | EudraCT Number |
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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| topiramate | Experimental | pill |
|
| placebo | Placebo Comparator | Sugar pill |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change from Baseline in Body Mass Index (BMI) | Success is defined by a percent change > 2.5% | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marie-Laure Frelut, MD | Assistance Publique - Hôpitaux de Paris | Study Chair |
| Gianpaolo De Filippo, MD, PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Bicêtre | Le Kremlin-Bicêtre | Paris | 94275 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18782881 | Background | 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. | |
| 14711062 | Background |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077236 | Topiramate |
| ID | Term |
|---|---|
| D005632 | Fructose |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 |
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|
| Placebo | Drug | Placebo will be taken orally following to the same dose regimen according to theoretical weight |
|
| 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 |
| Percent Change from Baseline in Body Mass Index and Body Mass Index Z-score | 6 months |
| Eating Behaviour | Self-administered questionnaires and scales : Binge Eating Scale ; State trait anxiety Inventory for Children; Child depression inventory, Child Behavior Checklist | 6 months |
| Eating Behaviour | Self-administered questionnaires and scales : Binge Eating Scale ; State trait anxiety Inventory for Children; Child depression inventory; Child Behavior Checklist | 9 months |
| Physical activity | Questionnaire from French Ministry of Health | 6 months |
| Physical activity | Questionnaire from French Ministry of Health | 9 months |
| Food intake | High-fat, sugary, salted food intake and beverage other than drinking water | 6 months |
| Food intake | High-fat, sugary, salted food intake and beverage other than drinking water | 9 months |
| Comorbidity outcome | Comorbidities and metabolic and cardiorespiratory complications | 6 months |
| Comorbidity outcome | Comorbidities and metabolic and cardiorespiratory complications | 9 months |
| 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. |
| 15536230 | 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. |
| 16703004 | 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. |
| 17363756 | 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. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Carbohydrates |
| D007661 | Ketoses |