Phase 2 N=30 Randomized Quadruple-blind Treatment

Topiramate in Adolescents With Severe Obesity

Obesity, Morbid · Obesity · Weight Loss

Bottom Line

View on ClinicalTrials.gov: NCT01859013 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2017

Primary outcome: Primary: Percent Change From Baseline in Body Mass Index at 28-Weeks — -2.74; -0.85 % change BMI

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Topiramate (Drug); Placebo (Other)
Age: Pediatric · 12+ yrs
Sex: All
Sponsor: University of Minnesota
Primary completion: Dec 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change From Baseline in Body Mass Index at 28-Weeks	-2.74; -0.85	—

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.

Eligibility Criteria

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01859013). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.