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Topiramate for Childhood Obesity (PHARMATOP Trial)

Phase < 1
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

PHARMATOP Trial Summary

This trial will use pharmacometrics to study the relationships between dose, exposure, and response to anti-obesity pharmacotherapy in order to optimize treatments for pediatric severe obesity.

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.Check my eligibility
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.See study design
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.

PHARMATOP Trial 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.

PHARMATOP Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To determine associations between topiramate exposure and 3-month BMI change using pharmacodynamic modeling

PHARMATOP 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

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,380 Previous Clinical Trials
1,588,677 Total Patients Enrolled
Eric Bomberg, MDPrincipal InvestigatorUniversity of Minnesota

Media Library

Topiramate Tablets Clinical Trial Eligibility Overview. Trial Name: NCT04986631 — Phase < 1
Childhood Obesity Research Study Groups: Topiramate
Childhood Obesity Clinical Trial 2023: Topiramate Tablets Highlights & Side Effects. Trial Name: NCT04986631 — Phase < 1
Topiramate Tablets 2023 Treatment Timeline for Medical Study. Trial Name: NCT04986631 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor still accepting participants?

"According to data collected on clinicaltrials.gov, this study is currently recruiting individuals as of 10/11/2022, beginning from 4/4/2022."

Answered by AI

Is enrollment being accepted for those aged 45 and above in this clinical experiment?

"According to the prerequisites for joining this trial, individuals aged between 12 and 18 can be considered eligible."

Answered by AI

How many participants are being recruited to partake in this clinical trial?

"Affirmative. Clinicaltrials.gov shows that this clinical trial is actively recruiting patients, with the initial posting on April 4th 2022 and a recent update on October 11th 2022. The study hopes to enrol 65 individuals from one medical centre."

Answered by AI

What indications are Topiramate Tablets typically prescribed for?

"Topiramate Tablets are used to treat hypertension and can also be deployed as a prophylactic for migraines, epilepsy, and obesity-related medical issues."

Answered by AI

Who can participate in this medical trial?

"The University of Minnesota is recruiting 65 adolescents with pediatric obesity from ages 12 to 18. To qualify, applicants must receive a medical assessment deeming them appropriate for topiramate treatment and have either a BMI </= 1.2 times the 95th percentile or higher than 35 kg/m2."

Answered by AI

Are there any previous investigations into the efficacy of Topiramate Tablets?

"Currently, 18 clinical trials of Topiramate Tablets are active with 3 in Phase 3. With many studies running out of Sherbrooke, Quebec and 30 other locations across the world participating as well."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Pharmacokinetics and Pharmacodynamics of Topiramate for Weight Loss in Youth: PHARMATOP
2022. "Pharmacokinetics and Pharmacodynamics of Topiramate for Weight Loss in Youth: PHARMATOP". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04986631.
~13 spots leftby Nov 2024
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