An open label, long-term extension study to evaluate the safety and efficacy of CRN00808 in subjects with acromegaly (ACROBAT ADVANCE)
This study, called ACROBAT ADVANCE, is looking into a new tablet medicine called paltusotine for adults with acromegaly, a condition where the body makes too much growth hormone. It's a 'Phase II' study, meaning researchers are still exploring how well it works and trying to find the best dose. The main goal of this study is to track any side effects people experience while taking paltusotine over a long period. Researchers will also be checking if the medicine helps to bring down levels of certain hormones (IGF-1 and growth hormone) that are high in people with acromegaly. By understanding the safety and effectiveness over time, this research helps doctors learn more about managing this condition.
At a glance
What is this study about?
This study is called ACROBAT ADVANCE and it's specifically for people who have a condition called acromegaly. Acromegaly happens when your body produces too much growth hormone, often because of a small, harmless growth in your pituitary gland, which is in your brain. This can lead to various physical changes and health problems over time. The study is looking at a new medicine in tablet form called paltusotine.
The main purpose of this study is to find out if paltusotine is safe to use over a long period. When doctors test new medicines, they always look very carefully at any side effects people might have. This study will keep a close eye on all side effects that people experience from the time they start taking the medicine. They also want to see if the medicine helps to control the high levels of hormones, like IGF-1 and growth hormone, that are typical in people with acromegaly. This is important because controlling these hormone levels can help manage the symptoms of acromegaly.
This type of study is called a 'Phase II' study, which means it’s still in the early stages of testing. Researchers are exploring how the medicine works, what the right dose might be, and whether it could be a helpful treatment option in the future. The results from studies like this help doctors understand new treatments better and decide if they should be tested in even larger groups of people. For participants, this could mean access to a new treatment option that isn't yet widely available.
Key takeaways
- This study is for adults with acromegaly.
- It's testing a new tablet medicine called paltusotine.
- The main goal is to check for long-term safety and side effects.
- Researchers will also see if it helps control hormones like growth hormone.
- It's a long-term study, requiring regular clinic visits.
Who may be eligible?
To be able to join this study, participants must be at least 18 years old. There's no upper age limit, meaning older adults can take part as long as they meet other health requirements.
Both men and women can participate in this research. The study aims to include a diverse group of people to make sure the findings are relevant to many individuals with acromegaly.
Because this is a long-term follow-up study, it's likely (though not explicitly stated in the summary) that you would need to have been part of an earlier study involving paltusotine. This allows researchers to track the medicine's effects over a longer period in people who are already familiar with it.
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.
- Are you 18 years old or older?
- Do you have a diagnosis of acromegaly?
- Are you able to take study medication as tablets?
- Are you willing to attend regular clinic visits for a long period?
What does participation involve?
If you join this study, you will be taking paltusotine tablets as prescribed. This is a long-term study, so you can expect to be involved for an extended period. Throughout this time, you will have regular visits to the clinic.
During these visits, the study team will carefully check your health. This will involve various assessments, likely including blood tests to measure your hormone levels (like IGF-1 and growth hormone) and generally check your overall health. They will also ask you about any side effects or changes you notice, as monitoring these is a key part of the study.
Your participation will continue for the duration of the study, and regular follow-up appointments will be scheduled to make sure your health is being monitored consistently. The exact number of visits and the total time you'll be involved would be explained in detail by the study team.
Potential risks and benefits
Locations (3)
- —UnverifiedHungary
- —UnverifiedGreece
- —UnverifiedGermany
Common questions
What is acromegaly?
Acromegaly is a condition where your body produces too much growth hormone, usually due to a small, harmless growth in your brain's pituitary gland, leading to various health issues.
What is paltusotine?
Paltusotine is a new medicine in tablet form that is being tested to help control the high hormone levels associated with acromegaly.
What does 'Phase II' mean?
Phase II means this is an early stage of testing. Researchers are exploring how well the medicine works, what the right dose might be, and closely watching for any side effects.
What should I expect during the study visits?
You can expect regular check-ups, potentially including blood tests to measure your hormone levels, and discussions about any side effects you might be experiencing.
Can I leave the study if I change my mind?
Yes, you are free to withdraw from the study at any time, for any reason, without it affecting your regular medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.