Ongoing Clinical Trials for Isodicentric Chromosome 15 Syndrome

Currently, there is 1 ongoing clinical trial for Isodicentric Chromosome 15 Syndrome, also known as Chromosome 15 Duplication Syndrome. This trial is investigating the long-term safety of an investigational medication called soticlestat for people with rare epileptic conditions, and it is being conducted across multiple European countries.

Clinical trial locations

• Poland
  • Study on Long-Term Safety of Soticlestat for Adults and Children with Developmental Epileptic Encephalopathies
• Portugal
  • Study on Long-Term Safety of Soticlestat for Adults and Children with Developmental Epileptic Encephalopathies
• Spain
  • Study on Long-Term Safety of Soticlestat for Adults and Children with Developmental Epileptic Encephalopathies

Study on Long-Term Safety of Soticlestat for Adults and Children with Developmental Epileptic Encephalopathies

This clinical trial focuses on evaluating the long-term safety and tolerability of soticlestat (also known as TAK-935) in individuals with Developmental Epileptic Encephalopathies. These rare forms of epilepsy include Dravet Syndrome, Lennox Gastaut Syndrome, CDKL5 Deficiency Disorder, and Chromosome 15 Duplication Syndrome. The study is designed to monitor how well people tolerate soticlestat when it is used together with their existing seizure treatments.

Main inclusion criteria:

• Participants must have taken part in a previous soticlestat study
• They should have either completed an earlier soticlestat study or received at least 10 weeks of treatment with the medication
• Participants must not have experienced serious or severe side effects that would make it unsafe to continue
• The study doctor must believe that participants have the potential to benefit from taking soticlestat
• The study is open to people of any gender and includes individuals from vulnerable populations who may need extra care

Main exclusion criteria:

• Patients with medical conditions other than the specific types of epileptic encephalopathies being studied
• Patients not currently using at least one anti-seizure therapy, such as anti-epileptic medications, a vagal nerve stimulator, or special diets like the ketogenic or modified Atkins diet
• Patients outside the specified age range for the study
• Patients unwilling or unable to follow the study procedures
• Patients with other medical conditions or situations that would make participation unsafe or inappropriate

Focus and goal of the trial:

The primary goal of this trial is to assess the long-term safety and tolerability of soticlestat when used as an additional therapy alongside other anti-seizure treatments. Participants will take soticlestat in tablet form, with a maximum daily dose of 600 milligrams, for a treatment period of up to 96 weeks. Throughout the study, researchers will closely monitor participants’ health, tracking any side effects, changes in behavior, seizure frequency, and other important health indicators. Regular assessments will include checking vital signs, body weight, and conducting laboratory tests. Behavioral and functional measures will be evaluated using specific scales to understand how the medication affects daily life and development. This extension study builds on earlier research, allowing scientists to gather more information about the medication’s effects over a longer period. The study is expected to continue until May 2026.

Investigational drug:

Soticlestat (TAK-935) is the medication being studied in this trial. It is an investigational antiepileptic drug, meaning it is still being researched and is not yet widely available for general medical use. Soticlestat works by targeting specific enzymes in the brain to help reduce the frequency of seizures. In this trial, it is administered orally as a tablet and is used alongside other treatments that patients are already taking for their epilepsy. The goal is to determine whether soticlestat can be safely used over a long period and whether patients can tolerate it without experiencing too many side effects.

Summary

There is currently one ongoing clinical trial available for people with Isodicentric Chromosome 15 Syndrome, which is also known as Chromosome 15 Duplication Syndrome. This trial is being conducted in three European countries: Spain, Poland, and Portugal. The study is investigating soticlestat, an investigational medication designed to help reduce seizures in people with rare developmental epileptic encephalopathies. This research represents an extension of earlier studies, focusing specifically on understanding the long-term safety profile of the medication when used alongside existing seizure treatments. The trial is open to both adults and children who have previously participated in soticlestat studies and continues to accept participants until 2026.