Topiramate in Adolescents With Severe Obesity (NCT01859013) | Clinical Trial Compass
CompletedPhase 2
Topiramate in Adolescents With Severe Obesity
United States34 participantsStarted 2013-06
Plain-language 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.
Who can participate
Age range
12 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* BMI ≥1.2 times the 95th percentile (based on gender and age) or BMI ≥35 kg/m2
* 12-18 years old
* Tanner stage IV or V by physical exam
Exclusion Criteria:
* Tanner stage I, II, or III
* Type 1 or 2 diabetes mellitus
* Previous (within 6-months) or current use of weight loss medication (patients may undergo washout)
* Previous (within 6-months) or current use of drugs associated with weight gain (e.g. steroids/anti-psychotics)
* Previous bariatric surgery
* Recent initiation (within 3-months) of anti-hypertensive or lipid medication
* Previous (within 6-months) or current use of medication to treat insulin resistance or hyperglycemia (patients may undergo washout)
* Major psychiatric disorder
* Females: Pregnant, planning to become pregnant, or unwilling to use 2 or more acceptable methods of contraception when engaging in sexual activity throughout the study
* Tobacco use
* Liver/renal dysfunction
* ALT or AST \>2.5 times the upper limit of normal
* Bicarbonate \<18 mmol/L
* Creatinine \>1.2 mg/dL
* Glaucoma
* Obesity associated with genetic disorder (monogenetic obesity)
* Hyperthyroidism or uncontrolled hypothyroidism
* History of suicidal thought/attempts
* History of kidney stones
* History of cholelithiasis
* Current use of other carbonic anhydrase inhibitor
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percent Change From Baseline in Body Mass Index at 28-Weeks