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MEASuRE: Metreleptin Effectiveness And Safety Registry

The MEASuRE study is looking at how a medicine called metreleptin works and its safety for people who have a rare condition called lipodystrophy. Lipodystrophy causes the body to lose fat in unusual ways. This study isn't a typical trial where new treatments are tested; instead, it's a 'registry.' This means it collects information from people who are already taking metreleptin as part of their regular care. Researchers want to learn more about how metreleptin affects people over time, including any side effects like pancreatitis or liver problems, and how it performs in everyday situations. This helps improve our understanding of the medicine beyond what was learned in earlier, smaller studies.

At a glance

Status
Recruiting
Sponsor
Amryt Pharma
Enrolment target
100
Start
11 Oct 2016
Estimated completion
31 Oct 2031

What is this study about?

The MEASuRE study, which stands for Metreleptin Effectiveness And Safety Registry, is designed to gather important long-term information about a medicine called metreleptin. This medicine is used to treat rare conditions called lipodystrophy, where the body either loses fat tissue generally (Generalised Lipodystrophy) or in specific areas (Partial Lipodystrophy). This isn't a new drug trial; instead, it's a careful way of observing how the medicine works for people who are already receiving it as part of their usual medical care.

The main goal of this study is to collect information from a large number of patients over time. This helps doctors and researchers understand the medicine better than they could from shorter, controlled trials. They are particularly interested in looking at specific side effects that might not show up often in smaller studies, such as issues with the pancreas (like pancreatitis), liver problems, low blood sugar (hypoglycemia), serious infections, allergic reactions, and even how the medicine might affect existing or new autoimmune conditions, or if it loses its effectiveness over time.

By collecting data from people using metreleptin in their daily lives, the study aims to provide a more complete picture of its safety and how well it works. This knowledge is incredibly valuable for healthcare professionals and patients alike, as it helps everybody make more informed decisions about the use of metreleptin for lipodystrophy.

Key takeaways

  • It's a study looking at a medicine called metreleptin for lipodystrophy.
  • It's about understanding real-world results and safety, not testing a new drug.
  • Participation involves sharing your routine medical information.
  • You continue your normal metreleptin treatment and doctor visits.
  • Your involvement helps improve knowledge for others with lipodystrophy.

Who may be eligible?

This study is open to both men and women of all ages. To be able to join, you must already be receiving treatment with metreleptin from a regular medical supply, not just as part of another research study. This could be because you've been on the medicine for a while, or perhaps you were in an earlier metreleptin study and are now continuing or restarting the treatment through your doctor.

Before you can participate, you will need to give your written permission (consent) to share your medical information for the study. This ensures you understand what's involved and agree to take part.

You would not be able to join this study if you are currently taking part in another clinical trial that involves a different experimental medicine or treatment.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you currently taking metreleptin as part of your regular medical treatment?
  2. Are you willing to provide your written permission for your medical information to be used?
  3. Are you NOT currently taking part in another study testing a new, experimental medicine?
Answer every question to see your result.

What does participation involve?

If you decide to take part in the MEASuRE study, it won't involve any extra visits beyond your usual doctor appointments for your lipodystrophy and metreleptin treatment. You will continue to take your metreleptin medicine as prescribed by your doctor. The study researchers will simply collect information from your routine medical records during your regular check-ups. There are no special tests or procedures required for this study other than what your doctor would normally do to monitor your health. The duration of your participation will depend on how long you continue to take metreleptin and are followed by your doctor.

Potential risks and benefits

The main benefit of taking part in this registry is that your medical information will help doctors and researchers learn more about metreleptin, leading to a better understanding for future patients with lipodystrophy. Since this isn't a new drug trial, there are no direct medical risks from participating beyond those already associated with taking metreleptin as part of your standard care. Your participation is voluntary, and you have the right to withdraw from the registry at any time without affecting your medical treatment.

Locations (28)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • University Alabama at Birmingham
    Verified postcode
    Birmingham, United States· Terminated
  • City of Hope
    Verified postcode
    Duarte, United States· Terminated
  • Atlanta Diabetes Associates
    Verified postcode
    Atlanta, United States· Active not recruiting
  • Ann & Robert H. Lurie Children's Hospital of Chicago
    Verified postcode
    Chicago, United States· Recruiting
  • University of Kansas Medical Center Research Institute, Inc.
    Verified postcode
    Kansas City, United States· Recruiting
  • Children's Hospital of New Orleans/LSU Health Sciences Center
    Verified postcode
    New Orleans, United States· Completed
  • Ochsner Clinic Foundation
    Verified postcode
    New Orleans, United States· Withdrawn
  • Nih/Niddk/Deob
    Verified postcode
    Bethesda, United States· Recruiting
  • University of Michigan
    Verified postcode
    Ann Arbor, United States· Recruiting
  • Childrens Hospital of Michigan
    Verified postcode
    Detroit, United States· Recruiting
  • Richmond University Medical Centre
    Verified postcode
    Staten Island, United States· Completed
  • Endocrinology Research Associates
    Verified postcode
    Columbus, United States· Recruiting

Common questions

What is the purpose of the MEASuRE study?

The study aims to learn more about the long-term safety and effectiveness of metreleptin for people with lipodystrophy, using information from patients' regular medical care.

Do I have to do anything differently if I join?

No, you don't. You will continue your metreleptin treatment and regular doctor visits as usual. The study just collects information from these routine appointments.

Will I get any special treatment or medicine if I join?

No, this study does not involve giving new treatments. It observes people already on metreleptin in their regular care.

Is my personal information kept private?

Yes, any information collected would be handled confidentially and used in a way that protects your privacy.

Can I leave the study if I change my mind?

Yes, you can choose to stop participating in the registry at any point without it affecting your medical care.

How to find out more

Lori Hartnett

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "MEASuRE: Metreleptin Effectiveness And Safety Registry…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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