Phentermine/Topiramate for Hypothalamic Obesity

Phase 2

Recruiting

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

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Treatment-emergent adverse events

Secondary study objectives

% 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.

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