Topiramate for Childhood Obesity

(PHARMATOP Trial)

Overseen By Eric Bomberg, MD

Age: < 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Minnesota

Must be taking: Topiramate

Must not be taking: Anti-obesity, Steroids, Antipsychotics, others

Disqualifiers: Bariatric surgery, Genetic disorders, Hyperthyroidism, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 3.5 months

65 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you have not used certain anti-obesity medications or medications associated with weight gain in the past 6 months unless you've been on a stable dose for at least 6 months. If you're taking long-acting stimulant medications, you must also have been on a stable dose for at least 6 months. Check with the trial team to see if your specific medications are affected.

What evidence supports the effectiveness of the drug Topiramate for childhood obesity?

Research shows that Topiramate can help with weight loss in children with severe obesity, as seen in a study where children experienced a decrease in BMI after 16 weeks of treatment. Additionally, Topiramate has been effective in weight loss for adults with obesity, suggesting it might also be beneficial for children. ^{1 2 3 4 5}

Is topiramate safe for use in children with obesity?

Topiramate has been used in children with obesity and is generally well tolerated, with most children experiencing no side effects. In some cases, mild side effects like drowsiness have been reported, but they can often be managed by adjusting the timing of the dose. Additionally, topiramate has been used safely in children for other conditions, such as epilepsy and nonalcoholic fatty liver disease, with similar safety profiles. ^{1 2 6 7 8}

How does the drug topiramate differ from other treatments for childhood obesity?

Topiramate is unique for childhood obesity as it is primarily an antiepileptic drug that also helps with weight loss by reducing impulsive eating and the desire to overeat. Unlike other treatments, it has been shown to be well-tolerated in children, with minimal side effects, and works by stabilizing brain pathways to reduce appetite. ^{1 2 3 5 9}

What is the purpose of this trial?

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.

Research Team

Eric Bomberg, MD

Principal Investigator

University of Minnesota

Eligibility Criteria

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.

Inclusion Criteria

I am between 12 and 17 years old.

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.

I am considered a good candidate for topiramate for weight loss by a specialist.

Exclusion Criteria

Baseline bicarbonate < 18 mmol/L

I have had weight loss surgery in the past.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive topiramate with dose escalation from 25 mg to 75 mg daily over 3.5 months

3.5 months

Weekly visits for dose adjustment in the first 3 weeks, then monthly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Topiramate

Trial Overview 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.

Participant Groups

Group I: Topiramate Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Findings from Research

Combination pharmacotherapy, such as using phentermine and topiramate together, may provide better weight loss results for pediatric patients with obesity compared to single-agent treatments, which often have limited efficacy.

This case report of a 10-year-old girl illustrates the potential benefits of combining medications after lifestyle modifications were insufficient, highlighting the need for more effective treatment options in pediatric obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Potential Role of Combination Pharmacotherapy to Improve Outcomes of Pediatric Obesity: A Case Report and Discussion. Fox, CK., Kelly, AS.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Topiramate for Weight Management in Children With Severe Obesity. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of topiramate controlled release in the treatment of obese type 2 diabetic patients. [2018]

3. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Sugar sulfamates for seizure control: discovery and development of topiramate, a structurally unique antiepileptic drug. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

The Potential Role of Combination Pharmacotherapy to Improve Outcomes of Pediatric Obesity: A Case Report and Discussion. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of topiramate on weight loss: a meta-analysis of randomized controlled trials. [2018]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Topiramate: Comprehensive profile. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Acute bilateral glaucoma and panuveitis as a side effect of topiramate for weight loss treatment. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Utilization of Topiramate as an Adjunct to Lifestyle Intervention for Weight Loss in Pediatric Nonalcoholic Fatty Liver Disease. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Treatment of affective disorder and obesity with topiramate. [2018]