An open label, single arm, extension trial to examine long-term safety of Iclepertin once daily in patients with schizophrenia who have completed previous Iclepertin Phase III trials.(CONNEX-X)
This research is an ongoing study focused on a medicine called Iclepertin, which is being investigated for the treatment of schizophrenia. If you've already participated in one of the previous main studies for Iclepertin, this new study offers a chance to continue taking the medicine and help us understand its long-term effects. The main goal is to carefully check for any side effects that might happen when people take Iclepertin for a longer time. We will also monitor how symptoms change for participants during this period. This helps doctors learn more about the complete safety and how well the treatment works over time for people with schizophrenia.
At a glance
What is this study about?
This study, called CONNEX-X, is an extension of previous research into a medicine named Iclepertin for people living with schizophrenia. If you've already been part of an earlier study looking into Iclepertin, this is an opportunity to continue taking the medicine under careful medical supervision.
The main purpose of this study is to gather more information about the long-term safety of Iclepertin. Researchers want to understand if there are any side effects that only appear after taking the medicine for an extended period. Your participation would help doctors learn a great deal about how the medicine works over time and its overall safety profile.
While the primary focus is on safety, the study will also look at how your symptoms may change throughout the study period. This helps researchers understand the complete picture of how Iclepertin affects people with schizophrenia in the long run. By joining, you'd be contributing vital information that could help others in the future.
Key takeaways
- This study looks at the long-term safety of Iclepertin for schizophrenia.
- It's only for people who have been in a previous Iclepertin study.
- You'll take Iclepertin daily and have regular health checks.
- The main goal is to find out about any side effects over time.
Who may be eligible?
To be considered for this study, you must be at least 18 years old. There's no upper age limit, meaning older adults are also welcome to participate.
Importantly, this study is specifically for people who have already taken part in one of the previous main studies (Phase III trials) for the medicine Iclepertin. This means you would have already received either Iclepertin or a placebo in the earlier study.
Both men and women are welcome to take part in this research, provided they meet the age and previous study participation requirements.
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?
- Have you already participated in a previous main study (Phase III) for Iclepertin?
- Do you have a diagnosis of schizophrenia?
- Are you willing to take study medication every day?
What does participation involve?
If you decide to take part, you'll continue to receive the study medicine, Iclepertin, once every day. You'll have regular visits with the study doctors and nurses, where they will check your health and ask you about any side effects you might be experiencing. They will also assess your symptoms of schizophrenia to see how you are doing. The total duration of your participation will depend on the study's plan, but it's designed to observe the long-term effects of the medication.
Potential risks and benefits
Locations (21)
- —UnverifiedNetherlands
- —UnverifiedCroatia
- —UnverifiedFinland
- —UnverifiedPortugal
- —UnverifiedBulgaria
- —UnverifiedBelgium
- —UnverifiedSweden
- —UnverifiedSpain
- —UnverifiedAustria
- —UnverifiedFrance
- —UnverifiedNorway
- —UnverifiedItaly
Common questions
What is Iclepertin?
Iclepertin is a new medicine being studied for the treatment of schizophrenia.
Why is this study needed?
This study helps us understand the long-term safety and effects of Iclepertin, especially for people who have already started taking it.
How long will I take part?
The study is designed to look at long-term effects, so your participation will involve an extended period, which the study team will explain.
Will I receive Iclepertin?
Yes, if you join this extension study, you will receive Iclepertin once daily.
Can I stop taking part if I change my mind?
Yes, you can leave the study at any time without having to give a reason, and it won't affect your 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.