Before we create, we listen; we listen to the patient’s voice as we design our therapies and clinical trials and we look for solutions that can be integrated in a seamless way into patients’ lives
We do so by partnering with patients and caregivers on a variety of topics to gain valuable feedback on all of our study related documents (protocol and ICF)
Recently Clexio partnered with the Depression Bipolar Support Alliance (DBSA) to evaluate the readability of the Inform Consent Form (ICF) designed for our Ph2 trial in patients suffering from Major Depressive Disorder (MDD). Thanks to the feedback received from the patients, we were able to modify the document to better explain the procedures that will take place during trial participation and ensure that the information included in this document is clear and concise.
Clinical trials serve as a pillar of scientific research and demand tremendous effort to fulfil their purpose. In clinical trials we ask patients to participate in a complex and sometimes laborious effort to evaluate the potential benefits of a drug or treatment that may affect their lives. Many hours are invested in planning these trials to ensure that they meet the highest scientific standards and are carried out in the most rigorous manner.
Designing a clinical trial with the patient in mind ensures as smooth as possible integration of the trial’s requirements into the patient’s life and helps retain patients in the study. Ongoing patient engagement activities across the industry ensure that future clinical trials are designed to reflect the patient’s perspective and .
Depression can occur in anyone. More than one in ten Americans will experience a major depressive episode at some point in their lives, and some estimates are even as high as one in five. Depression can cause a person to lose interest and enjoyment in life, have trouble taking care of themselves and their loved ones, feel overly sad and tense, and be pessimistic and down. These feelings can persist for weeks and months, making it hard for a person to function the way they normally would at home, at work, and with their friends and family. Many people suffering from a major depressive episode respond to treatment but, still, millions of Americans will not have sufficient improvement of their depression symptoms after first or even second line antidepressant medications.
CLE-100 is a tablet being developed as an add-on treatment for patients suffering from major depressive disorder who do not get enough relief from standard antidepressant medications.
SOLEO
Clexio is currently conducting a Phase 2, randomized, double blind , placebo-controlled study to assess the efficacy and safety of CLE-100 tablet, for the treatment of depression in adult subjects with Major Depressive Disorder who have had an inadequate response to at least 2 previous antidepressants.
The SOLEO study is currently enrolling participants at various sites across the US.
For more information on this study please visit: https://clinicaltrials.gov/study/NCT06340958?term=clexio&rank=1