protocolSection identificationModule nctId: NCT06299891, orgStudyIdInfo id: PhT_HypOb_Protocol_Clean_07-05, briefTitle: Efficacy and Safety of Phentermine/Topiramate in Youth With Hypothalamic Obesity, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-05-31, completionDateStruct date: 2026-05-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Seattle Children's Hospital, class: OTHER, collaborators name: Children's Hospital of Philadelphia, descriptionModule briefSummary: Hypothalamic obesity (HO) refers to the substantial weight gain that often complicates hypothalamic brain tumors. Children with this treatment-recalcitrant form of obesity have excess rates of metabolic sequelae compared to otherwise healthy children with similar obesity, and later experience excess mortality related to cardiometabolic disease. In this pilot trial, our objective is to gather key preliminary data about phentermine/topiramate (Ph/T) that is FDA-approved for "common" obesity but has never been tested in HO. The subset of individuals with HO who experience hyperphagia or excess daytime sleepiness may benefit from the Ph/T-induced decrease in appetite and increase in alertness.Preliminary assessments of safety, adverse events, dosing (Aim 1), as well as of efficacy (% BMI loss, Aim 2) will be made in a 28-week parallel-arm double-blinded Phase 2 placebo-controlled clinical trial in 12-28-year-old individuals with HO., conditionsModule conditions: Hypothalamic Obesity, conditions: Hypothalamic Tumor, conditions: Craniopharyngioma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Two-center, double-blind (participant and assessor), randomized, parallel-arm placebo-controlled 28-week clinical trial, comparing changes related to active drug (Qsymia®) vs. placebo (matched capsules)., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Eligible subjects will be assigned treatment using a sex-stratified permuted-block randomization (1:1) to drug vs. placebo for 27 weeks with varying block sizes constructed by the study statistician., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Phentermine / Topiramate Extended Release Oral Capsule [Qsymia], interventions name: Placebo, outcomesModule primaryOutcomes measure: Treatment-emergent adverse events, secondaryOutcomes measure: Maximum tolerated dose, secondaryOutcomes measure: % change in BMI, secondaryOutcomes measure: Proportion of individuals who experience 5% decrease in BMI, secondaryOutcomes measure: Proportion of individuals who experience 2.5% decrease in BMI, secondaryOutcomes measure: Change in body fat mass, secondaryOutcomes measure: Change in visceral fat mass, secondaryOutcomes measure: Change in hunger, secondaryOutcomes measure: Change in energy intake, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 28 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: The Children's Hospital of Philadelphia, city: Philadelphia, state: Pennsylvania, zip: 19104, country: United States, geoPoint lat: 39.95233, lon: -75.16379, locations facility: Seattle Children's, city: Seattle, state: Washington, zip: 98101, country: United States, contacts name: Clinton Elfers, role: CONTACT, phone: 513-290-5710, email: clinton.elfers@seattlechildrens.org, geoPoint lat: 47.60621, lon: -122.33207, hasResults: False