Topiramate in Adolescents With Severe Obesity
Condition: Obesity, Morbid; Obesity; Weight Loss
MeSH terms: Obesity; Obesity, Morbid; Weight Loss
Study type: Interventional
Phase: Phase 2

Summary: 
      The prevalence of severe pediatric obesity is on the rise and youth with this condition are
      at elevated risk for developing chronic diseases such as cardiovascular disease (CVD) and
      type 2 diabetes mellitus (T2DM). Topiramate, a medication approved by the Food and Drug
      Administration (FDA) for the treatment of seizures in adults and children, is associated with
      weight loss. Although not FDA approved for the treatment of obesity, studies in obese adults
      have demonstrated weight reduction of approximately 5% with 6-12 months of therapy. However,
      the weight loss effect of topiramate has never been evaluated among children and adolescents.
      Therefore, the goal of this pilot study is to evaluate the safety and efficacy of 24 weeks of
      topiramate therapy with a 4-week run-in of meal replacement therapy in adolescents with
      severe obesity. The primary hypothesis is that 4 weeks of meal replacement therapy followed
      by 24 weeks of topiramate will have a larger average percent decline in BMI between baseline
      and 28 weeks compared to meal replacement therapy followed by placebo.
    

Detailed description: 
      The prevalence of severe pediatric obesity is on the rise and youth with this condition are
      at elevated risk for developing chronic diseases such as cardiovascular disease (CVD) and
      type 2 diabetes mellitus (T2DM). Lifestyle modification therapy alone is ineffective for most
      adolescents with severe obesity and few patients qualify for bariatric surgery. Many patients
      would likely benefit from pharmacotherapy but only one medication (orlistat) is approved for
      use in adolescents but notable side effects and limited efficacy impede its clinical use.
      Topiramate, a medication approved by the Food and Drug Administration (FDA) for the treatment
      of seizures in adults and children, is associated with weight loss. Although not FDA approved
      for the treatment of obesity, studies in obese adults have demonstrated weight reduction of
      approximately 5% with 6-12 months of therapy. However, the weight loss effect of topiramate
      has never been evaluated among children and adolescents. Therefore, the goal of this pilot
      study is to evaluate the safety and efficacy of 24 weeks of topiramate therapy with a 4-week
      run-in of meal replacement therapy in adolescents with severe obesity.

      This will be a 28-week, randomized, double-blind, placebo-controlled, pilot clinical trial of
      meal replacement therapy (4 weeks) followed by topiramate (24 weeks) vs. meal replacement
      therapy (4 weeks) followed by placebo (24 weeks) for BMI reduction and cardiometabolic risk
      factor improvement in 36 adolescents (ages 12-17 years old) with severe obesity. Monthly
      lifestyle modification/behavioral counseling will be delivered by trained study coordinators
      to patients in both groups. The lifestyle modification education materials will be given to
      patients and selected sections will be discussed at each monthly contact (five face-to-face
      sessions and three phone sessions).
    

Intervention name(s): Topiramate; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Topiramate will be initiated at a dose of 25 mg (taken orally once daily in the evening), escalated to 50 mg (taken orally once daily in the evening) after 1 week, and escalated to 75 mg (taken orally 25 mg in the morning and 50 mg in the evening) after 2 weeks. Patients who do not tolerate dose escalation will be reduced to the highest tolerated dose for the remainder of the trial.; Placebo will be taken orally once daily in the evening for the first two weeks, and orally twice daily (AM and PM) for the remainder of the study.
Other intervention name(s): Topamax; Sugar Pill
Intervention MeSH terms: Topiramate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment