CDKL5 deficiency disorder – European Clinical Trials Information Network https://clinicaltrials.eu Bridging Patients with Clinical Trials Fri, 12 Jun 2026 10:37:09 +0000 en-US hourly 1 https://wordpress.org/?v=7.0 https://clinicaltrials.eu/wp-content/uploads/2024/12/cropped-EU_icon-32x32.png CDKL5 deficiency disorder – European Clinical Trials Information Network https://clinicaltrials.eu 32 32 Study on the Effectiveness and Safety of Fenfluramine Hydrochloride for Patients with CDKL5 Deficiency Disorder https://clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-fenfluramine-hydrochloride-for-patients-with-cdkl5-deficiency-disorder/ Wed, 29 Apr 2026 15:01:01 +0000 https://clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-fenfluramine-hydrochloride-for-patients-with-cdkl5-deficiency-disorder/ This clinical trial is focused on studying a rare genetic condition known as CDKL5 Deficiency Disorder (CDD). This disorder is characterized by seizures, developmental delays, and motor difficulties. The study is testing a treatment called Fenfluramine hydrochloride, which is also referred to by its code name, ZX008. This medication is being evaluated to see if it can help reduce seizures in individuals with CDD. Participants in the study will receive either the medication or a placebo, which looks like the medication but does not contain the active ingredient.

The purpose of the study is to assess the effectiveness and safety of ZX008 in treating CDD. The study will be conducted in two parts. In the first part, participants will be randomly assigned to receive either ZX008 or a placebo. This part of the study is designed to be “double-blind,” meaning neither the participants nor the researchers will know who is receiving the actual medication. After this phase, all participants will have the opportunity to receive ZX008 in an “open-label” extension, where everyone knows they are receiving the medication. The study will last for a total of 74 weeks, during which the participants’ seizure activity and overall health will be closely monitored.

The study aims to demonstrate that ZX008 is more effective than a placebo in reducing seizures and improving the overall condition of individuals with CDD. Additionally, the study will gather information on the long-term safety and tolerability of the medication. Participants will be required to attend regular visits to monitor their progress and report any changes in their condition. This trial is an important step in finding a potential treatment for those affected by CDKL5 Deficiency Disorder.

]]> Study on Long-Term Safety of Soticlestat for Adults and Children with Developmental Epileptic Encephalopathies https://clinicaltrials.eu/trial/study-on-long-term-safety-of-soticlestat-for-adults-and-children-with-developmental-epileptic-encephalopathies/ Wed, 29 Apr 2026 14:23:27 +0000 https://clinicaltrials.eu/trial/study-on-long-term-safety-of-soticlestat-for-adults-and-children-with-developmental-epileptic-encephalopathies/ This clinical trial is focused on studying the long-term safety and tolerability of a medication called soticlestat (also known by its code name TAK-935). The study is designed for individuals with certain types of rare epilepsies, specifically Developmental Epileptic Encephalopathies. These include conditions such as Dravet Syndrome, Lennox Gastaut Syndrome, CDKL5 Deficiency Disorder, and Chromosome 15 Duplication Syndrome. The purpose of the study is to see how well soticlestat can be tolerated when used alongside other treatments for seizures, such as anti-seizure medications, a vagal nerve stimulator, or special diets like the ketogenic or modified Atkins diet.

Participants in this study will take soticlestat in the form of a tablet, which is taken orally. The study will follow participants over a period to monitor their health and any side effects they might experience. The maximum daily dose of soticlestat is 600 milligrams, and the treatment period can last up to 96 weeks. Throughout the study, researchers will keep track of any adverse events, changes in behavior, and other health indicators to ensure the safety of the participants.

This study is an extension of previous research, meaning that participants have already been involved in earlier studies of soticlestat. The goal is to gather more information about how the medication affects people over a longer period. By doing so, researchers hope to better understand the potential benefits and risks of using soticlestat as a treatment for these rare epileptic conditions.

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