Topiramate in Adolescents With Severe Obesity

NCT01859013 | Completed Phase 2 Results DMC

• 1 other identifier: 1304M31241
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity, Morbid; Obesity; Weight Loss

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline in Body Mass Index at 28-Weeks

  The Percent Change from Baseline in Body Mass Index at 28-Weeks

  Baseline and 28-Weeks

Study Arms (2)

Topiramate

EXPERIMENTAL

Four (4) weeks of meal replacement therapy, followed by 28-weeks of topiramate therapy. 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.

Drug: Topiramate

Sugar Pill

PLACEBO COMPARATOR

Four (4) weeks of meal replacement therapy, followed by 28-weeks of placebo (sugar pill) therapy.

Other: Placebo

Interventions

Topiramate DRUG

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.

Also known as: Topamax

Topiramate

Placebo OTHER

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.

Also known as: Sugar Pill

Sugar Pill

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• BMI ≥1.2 times the 95th percentile (based on gender and age) or BMI ≥35 kg/m2
• years old
• Tanner stage IV or V by physical exam

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

• Fox CK, Kaizer AM, Rudser KD, Nathan BM, Gross AC, Sunni M, Jennifer Abuzzahab M, Schwartz BL, Kumar S, Petryk A, Billington CJ, Ryder JR, Kelly AS. Meal replacements followed by topiramate for the treatment of adolescent severe obesity: A pilot randomized controlled trial. Obesity (Silver Spring). 2016 Dec;24(12):2553-2561. doi: 10.1002/oby.21633. Epub 2016 Nov 3.

  PMID: 27807925 DERIVED

MeSH Terms

Conditions

Obesity, Morbid; Obesity; Weight Loss

Interventions

Topiramate; Sugars

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Carbohydrates; Ketoses

Results Point of Contact

• Title: Claudia Fox
• Organization: University of Minnesota

lusc0001@umn.edu

612-626-6616

Study Officials

• Aaron S Kelly, Ph.D.

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2013
• First Posted: May 21, 2013
• Study Start: June 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: April 1, 2017
• Last Updated: July 2, 2017
• Results First Posted: July 2, 2017

Record last verified: 2017-06

Locations

US (1)