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Anti-obesity Medication

Drug Intervention for Hypothalamic Obesity

Phase 2

Waitlist Available

Led By Christian L Roth, MD

Research Sponsored by Seattle Children's Hospital

Eligibility Criteria Checklist

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

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 0 to 28

Awards & highlights

Study Summary

This trial aims to study the effects of the medication phentermine/topiramate (Ph/T) on hypothalamic obesity (HO) in individuals aged 12-28 years. HO is a

Who is the study for?

This trial is for young people aged 12-28 with hypothalamic obesity, often due to brain tumors like craniopharyngioma. Participants should have issues with excessive hunger or sleepiness. Key eligibility details are not provided, so it's assumed that standard health requirements and consent apply.Check my eligibility

What is being tested?

The trial tests Phentermine/Topiramate capsules (Qsymia), which may reduce appetite and increase alertness in patients with hypothalamic obesity. It's a double-blinded study comparing the drug against a placebo over 28 weeks to see if it helps lower BMI and improve other health aspects.See study design

What are the potential side effects?

While specific side effects for this population aren't listed, Qsymia can generally cause mood changes, trouble sleeping, dizziness, taste alterations, constipation or heart palpitations in some individuals.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 0 to 28

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 0 to 28

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0 to 28 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Treatment-emergent adverse events

Secondary outcome measures

% change in BMI

Change in body fat mass

Change in energy intake

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Drug InterventionExperimental Treatment1 Intervention

Active drug dose escalation and adjustment: The drug had been used in adolescents with obesity before. For this trial, the FDA approved dose titration will be followed until the highest tolerable dose is reached.

Group II: PlaceboPlacebo Group2 Interventions

Matching placebo using capsules matching the appearance of the active drug.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Children's Hospital of PhiladelphiaOTHER

710 Previous Clinical Trials

8,588,884 Total Patients Enrolled

Seattle Children's HospitalLead Sponsor

306 Previous Clinical Trials

5,218,373 Total Patients Enrolled

1 Trials studying Hypothalamic Obesity

42 Patients Enrolled for Hypothalamic Obesity

Christian L Roth, MDPrincipal InvestigatorUniversity of Washington, Dept. of Pediatrics

1 Previous Clinical Trials

16 Total Patients Enrolled

Frequently Asked Questions

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

Are individuals who are 85 years of age and older eligible to participate in this trial?

"Potential candidates must be adolescents aged 12 years or older but younger than 28 years to qualify for participation in this research."

Answered by AI

Are there any available openings for participation in this study at the moment?

"As per clinicaltrials.gov, recruitment for this trial is currently closed. The initial posting was on March 1st, 2024 and the latest update was also on March 1st, 2024. While this specific study is not enrolling participants presently, there are over a thousand other active studies seeking patients at the moment."

Answered by AI

Has the drug intervention received approval from the FDA?

"In this Phase 2 trial, the safety assessment for Drug Intervention stands at a level of 2 as per our evaluation. This indicates there is existing data supporting its safety profile but no evidence yet on its efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Efficacy and Safety of Phentermine/Topiramate in Youth With Hypothalamic Obesity

Christian L Roth, MD 2024. "Efficacy and Safety of Phentermine/Topiramate in Youth With Hypothalamic Obesity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06299891.

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