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Top 10 Hypothalamic-Pituitary Brain Tumor Clinical Trials [2024 Studies] | Power

Hypothalamic-Pituitary Brain Tumor Clinical Trials

Hypothalamic-pituitary brain tumor studies recruiting patients for novel treatments. Filter by phase, distance, and inclusion criteria to find your perfect sjia clinical trial.

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.

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

My kidney function is low (GFR under 60).

My thinking or memory problems don't stop me from joining the study.

I am currently taking medication that inhibits carbonic anhydrase.

I have diabetes that needs insulin and my HbA1c level is above 8.5%.

I am using effective birth control or have a condition that prevents me from getting pregnant.

I don't have glaucoma or hyperthyroidism, making me eligible for Phentermine or Topiramate.

I haven't started new weight loss drugs or lost more than 5% of my weight recently.

I have a history of metabolic acidosis or bone disease needing treatment beyond calcium or vitamin D.

I have used a monoamine oxidase inhibitor in the last 14 days.

My brain MRI shows hypothalamic injury, and it's been over 6 months since my last major cancer treatment. No surgeries are planned.

I am not pregnant, breastfeeding, nor planning to become pregnant during the trial.

My liver is not functioning well, with high ALT and AST levels.

I am currently taking high doses of steroids.

I have been on stable doses of medications for pituitary issues or appetite control for 2 months.

I have had surgery on my stomach or abdomen.

I have a serious heart condition, such as high blood pressure, arrhythmia, heart failure, or coronary artery disease.

Principal investigator

Phentermine/Topiramate

The purpose of this study is to evaluate the safety, tolerability, and PK of RM-718 in healthy subjects with obesity and in patients with hypothalamic obesity (HO).

A Study of RM-718 in Healthy Subjects and in Patients With HO

I can communicate well and understand the trial's requirements.

My obesity is caused by genetic, syndromic, or hormonal reasons.

I am between 18-55 years old, in good health, and have a BMI of 30 or higher.

I am between 12-65 years old with weight gain due to hypothalamic injury.

I have had a kidney transplant or have end-stage kidney disease.

I have not had weight loss surgery in the past 2 years.

I have not had surgery in the last 60 days.

I have or had a serious health condition affecting my organs or systems.

I am generally healthy with no significant medical issues.

My obesity was caused by genetic conditions before any brain injury.

I have been diagnosed with Prader-Willi syndrome or ROHHADNET.

I have lost more than 2% of my weight in the last 3 months or am on anti-obesity medication.

I do not have severe lung, heart, metabolic, or cancer-related health issues that could affect the trial.

I do not have severe mental health issues or thoughts of harming myself.

RM-718

Pivotal Trial

The goal of this trial is to learn how well Setmelanotide works to improve weight reduction, hunger, and quality of life in patients 4 years of age and older with acquired Hypothalamic Obesity (HO). To determine how well setmelanotide works and how safe it is, patients with HO will take a daily injection of either setmelanotide or placebo and complete trial assessments for up to 60 weeks.

A Trial of Setmelanotide in Acquired Hypothalamic Obesity

Setmelanotide for Hypothalamic Obesity

I or my close family have a history of skin cancer or melanoma.

I have lost more than 2% of my weight in the last 3 months.

I have serious skin changes related to melanoma, not including minor skin cancers.

My hormone therapy dose has been the same for the last 2 months.

I have been diagnosed with hypothalamic obesity.

I cannot follow a daily injection schedule.

I have never participated in a trial or taken setmelanotide before.

My obesity is due to a genetic condition, not an injury to the hypothalamus.

I have a serious lung, heart, metabolic, or cancer-related condition.

I have gained weight due to a brain injury and my BMI is over 30 if I'm an adult, or over the 95th percentile for my age and sex if I'm under 18.

Hypothalamic-Pituitary Brain Tumor Clinical Trials

Phentermine/Topiramate for Hypothalamic Obesity

RM-718 for Hypothalamic Obesity

Setmelanotide for Hypothalamic Obesity