Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04986631 · ClinicalTrials.gov registry record · Early Phase 1
Pharmacokinetics and Pharmacodynamics of Topiramate for Weight Loss in Youth: PHARMATOP
A Early Phase 1 study of Obesity, Childhood, sponsored by University of Minnesota.
- Active
- Registry status
- Early Phase 1
- Development phase
- 62
- Enrollment target
- 1
- Study location
NCT04986631: Active Early Phase 1 study of Obesity, Childhood, sponsored by University of Minnesota.
NCT04986631 is a Early Phase 1 study of Obesity, Childhood that is active but no longer recruiting, run by University of Minnesota. The registered enrollment target is 62 participants, below the 343-participant average among 53 other Obesity, Childhood trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04986631, a Early Phase 1 study of Obesity, Childhood, is active but no longer recruiting, sponsored by University of Minnesota.
- ACTIVE NOT RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 62 participants
- Enrollment target
- 1
- Study location
Study Summary
Pediatric severe obesity is the fastest growing obesity category in the United States, and anti-obesity pharmacotherapies are promising adjuncts to lifestyle modification (LSM) for the treatment of this disease. While anti-obesity pharmacotherapies have overall been associated with mean weight loss, there is substantial variability in their individual-level effectiveness. While some patients lose a significant amount of weight with anti-obesity pharmacotherapies, others lose little or even gain weight. Due to this well-recognized variability in individual-level response, the National Institutes of Health (NIH) has recognized the importance of using precision medicine approaches in order to optimize treatments for pediatric severe obesity. Pharmacometrics, which uses mathematical models to study medication dose-exposure (i.e. blood drug concentrations)-response relationships, is an emerging science that can help determine optimal dosing regimens based upon patient-specific characteristics. Pharmacometrics quantitates the interplay between pharmacokinetics (PK; drug dose-exposure associations) and pharmacodynamics (PD; drug exposure-response associations). Population PK (popPK), a type of PK, can be used to quantitate variability in drug exposure among individuals in order to help inform recommendations on therapeutic individualization (e.g. through tailored dosing). In this study, investigators will use popPK/PD modeling to characterize associations between anti-obesity pharmacotherapy dose, exposure, and changes in weight and weight-related outcomes in youth with severe obesity. This study will focus on topiramate because this medication is commonly prescribed for weight loss in youth with severe obesity and has been associated with highly variable individual-level effectiveness.
Primary Outcome
Percent change in body mass index (BMI) from baseline to 14 weeks (mean change from baseline to 14 weeks of follow up, analysis using paired t-tests)
Conditions Studied
Interventions
- DRUG Topiramate Tablets
Study Locations (1)
Minnesota
- University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2022-04-04 |
| Est. Completion | 2026-03-12 |
| Phase | Early Phase 1 |
What the registry record for NCT04986631 still lists
NCT04986631 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 343-participant average among 53 other Obesity, Childhood trials with a reported enrollment target (82% lower).
The record links to 1 condition, with Obesity, Childhood appearing as the primary indexed condition, and to 1 intervention - of which Topiramate Tablets is the first listed.
NCT04986631 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT04986631 about?
NCT04986631 is a clinical study titled "Pharmacokinetics and Pharmacodynamics of Topiramate for Weight Loss in Youth: PHARMATOP". Pediatric severe obesity is the fastest growing obesity category in the United States, and anti-obesity pharmacotherapies are promising adjuncts to lifestyle modification (LSM) for the treatment of this disease. While anti-obesity pharmacotherapies have overall been associated with mean weight loss,...
What is the current status of trial NCT04986631?
This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 62 participants. The study started on 2022-04-04. Estimated completion is 2026-03-12.
What conditions does trial NCT04986631 study?
This clinical trial studies the following conditions: Obesity, Childhood.
What interventions are being tested in trial NCT04986631?
The interventions under investigation include: Topiramate Tablets (DRUG).
Who is sponsoring clinical trial NCT04986631?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04986631 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Obesity, Childhood
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04986631's enrollment target sits among peer trials
62 39th of 53 higher than 15 of 53 other Obesity, Childhood trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity, Childhood trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Vyvanse in Children Aged 6 to 12 Years
ACTIVE NOT RECRUITING · Early Phase 1
-
Breastmilk in Response to a Bout of Exercise
RECRUITING
-
Food-Body-Mind Intervention (16 Weeks)
RECRUITING · Phase 2
-
Interoception and Eating Behaviors in Children
RECRUITING
-
Bringing Weight Management Into the Primary Care Pediatric Practice
RECRUITING
-
Increasing Food Literacy in Preschoolers to Reduce Obesity Risk
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03231150 · 62 participants · NA
Plantar Fasciitis Randomized Clinical Control Trial
- NCT03458676 · 62 participants · NA
Radiologic Pathologic Correlation of Advanced MR Imaging to Guide the Biopsy of Cerebral Malignancies
- NCT03596086 · 62 participants · Phase 1
HSV-tk + Valacyclovir + SBRT + Chemotherapy for Recurrent GBM
- NCT03603405 · 62 participants · Phase 1
HSV-tk and XRT and Chemotherapy for Newly Diagnosed GBM
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI