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Topiramate for Childhood Obesity (PHARMATOP Trial)

Phase < 1

Waitlist Available

Led By Eric Bomberg, MD

Research Sponsored by University of Minnesota

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ages 12 to < 18 years old

Body mass index (BMI) </= 1.2 times the 95th percentile (age and sex-adjusted) and/or BMI >/= 35 kg/m2

Must not have

History of metabolic/bariatric surgery

Females: pregnant, planning to become pregnant, or, if sexually active, unwilling to use 2+ acceptable contraceptive methods during the study period

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial studies how well topiramate helps children with severe obesity lose weight. The medication works by making them feel less hungry and less interested in certain foods. Researchers will look at how different factors like age and body size affect how well the drug works for each child. Topiramate has been studied for its weight loss effects in both adults and children, showing promise in reducing body weight and being relatively safe compared to other obesity drugs.

Who is the study for?

This trial is for youth aged 12 to under 18 with severe obesity, defined as a BMI at or above certain thresholds. Candidates must be considered appropriate for topiramate treatment by an obesity specialist and have no history of metabolic surgery, significant thyroid disorders, major psychiatric disorders, eating disorders, recent suicide attempts or use of certain weight-related medications.

What is being tested?

The PHARMATOP study tests how the drug topiramate affects weight loss in young people with severe obesity. It uses pharmacometrics to understand the relationship between dosage and individual responses to optimize dosing based on patient-specific characteristics.

What are the potential side effects?

Topiramate can cause side effects such as tingling in hands/feet, taste changes, diarrhea, weight loss, drowsiness, dizziness or confusion. More serious risks include vision problems (glaucoma), kidney stones or mood disturbances like depression.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 12 and 17 years old.

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My BMI is either less than or equal to 1.2 times the 95th percentile for my age and sex, or it is 35 kg/m2 or more.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had weight loss surgery in the past.

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I am not pregnant, not planning to become pregnant, and willing to use two or more forms of birth control if sexually active.

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I have had kidney stones in the past.

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I am obese due to a genetic condition.

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I have had seizures that were not caused by fever.

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I have not had thoughts of harming myself or suicide in the last 30 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To determine associations between topiramate exposure and 3-month BMI change using pharmacodynamic modeling

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: TopiramateExperimental Treatment1 Intervention

Individuals will receive 75 mg of topiramate daily. The dose will start at 25 mg daily for the first week. The second week participants will receive 50 mg daily. Starting at week 3 participants will take 75 mg daily.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Topiramate Tablets

2001

Completed Phase 1

~30

0 / 8Eligibility criteria met