Enhancing seizure control: Soticlestat’s impact in Dravet and Lennox-Gastaut Syndromes

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    What is this study about?

    This trial examines soticlestat as an additional therapy for children and adults with Dravet Syndrome or Lennox-Gastaut Syndrome, aiming to reduce seizure frequency. Participants, continuing their standard anti-seizure treatments, receive soticlestat tablets, with the study monitoring seizure reduction and overall health impacts, offering hope for better seizure management in these conditions.

    Learn more about this Trial

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      Locations

      Where does the clinical trial take place?

      Edegem , Belgium

      Edegem , Belgium

      Ottignies-Louvain-la-Neuve , Belgium

      Brussel , Belgium

      Marseille , France

      Dijon , France

      Lille , France

      Paris , France

      Paris , France

      Freiburg , Germany

      Frankfurt am Main , Germany

      Bielefeld , Germany

      Radeberg , Germany

      Athens , Greece

      Chaidari , Greece

      Larisa , Greece

      Thessaloniki , Greece

      Pecs , Hungary

      Budapest , Hungary

      Budapest , Hungary

      Budapest , Hungary

      Roma , Italy

      Roma , Italy

      Roma , Italy

      Mantova , Italy

      Pavia , Italy

      Firenze , Italy

      Heeze , Netherlands

      Zwolle , Netherlands

      Krakow , Poland

      Warszawa , Poland

      Gdansk , Poland

      Poznan , Poland

      Pamplona , Spain

      Almeria , Spain

      Barcelona , Spain

      Granada , Spain

      Sevilla , Spain

      Valencia , Spain

      You can join this study in:

      Study Steps

      How Complex Will My Study Be and What Phases Will I Go Through?

      As a patient in this clinical trial, the following steps need to be taken:

      1. Receive soticlestat based on your weight during the 2-week Titration Period (for participants who roll over from an antecedent double-blind study).
      2. After the Titration Period, continue to receive the same dose of soticlestat in the Maintenance Period.
      3. At the end of the Maintenance Period, the dose will be down-tapered (unless it’s already at the lowest dose) and then stopped.
      4. If you are not tolerating the minimum dose of 100 mg twice a day (BID), you will be discontinued from the study.
      5. The overall time to participate in the study will be approximately 4 years, or until the study is stopped at the discretion of the sponsor, or the product is approved and launched.
      6. If you discontinue study drug treatment before the completion of the study, you will continue to be followed per protocol and maintain a daily seizure diary until the final follow-up phone call.

      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      To be eligible to join the study, participants must have been previously enrolled in a phase 3 soticlestat clinical study. No specific diseases were mentioned in the inclusion criteria within the provided segment, but rather a previous participation requirement. If you would like more detailed information or if you have a specific disease you are inquiring about, please let me know, so I can assist you further.


      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      Inclusion Criteria for joining the study:

      1. You must have been previously enrolled in a phase 3 soticlestat clinical study. For clarity, soticlestat is the study medication being investigated.

      Medical terms explanations:

      No specific medical terms or indices that require explanation were mentioned in the inclusion criteria provided.

      What Reasons Could Exclude Me from the Study?

      Conditions that may prevent you from taking part in the study:

      1. Unstable, Clinically Significant Neurologic or Other Disorders: Having an unstable condition that is neurologic (aside from the one being studied), psychiatric, cardiovascular, ophthalmologic (eye-related), pulmonary (lung-related), hepatic (liver-related), renal (kidney-related), metabolic, gastrointestinal (digestive system-related), urologic (urinary system-related), immunologic (immune system-related), hematopoietic (blood-forming), endocrine (hormone-related) disease, or cancer, including progressive tumors. These conditions might affect your ability to participate or could interfere with the study results.
      2. Clinically Significant ECG Abnormality: An abnormal electrocardiogram (ECG), specifically a QT interval that is corrected for heart rate (using Fridericia’s formula) and is more than 450 milliseconds, confirmed with a second ECG.
      3. Imminent Risk of Suicide or Injury: If the investigator believes you are at an immediate risk of suicide or injuring yourself, others, or property. This includes participants who answer positively to item numbers 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) prior to dosing. The C-SSRS is a questionnaire used to assess suicide risk.

      Please note, these are summaries of exclusion criteria with explanations for some medical terms provided for better understanding. The full assessment of any medical condition’s impact on study participation is at the discretion of the study investigator, who may consult with the medical monitor if necessary.


      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The clinical study involves the drug soticlestat (active substance: TAK-935).

      Here is a brief description of soticlestat (TAK-935):

      1. Soticlestat is being tested for long-term administration in pediatric and adult participants with Dravet Syndrome (DS) or Lennox-Gastaut Syndrome (LGS). The purpose of the study is to assess the safety, tolerability, efficacy, palatability, and acceptability of soticlestat in the pediatric population. The study is being conducted worldwide and intends to enroll approximately 400 participants.

      Have the Medicinal Substances Used in the Trial Been Previously Studied in Medicine?

      The clinical trial is investigating the following active substance:

      1. Soticlestat: Soticlestat (also known as TAK-935) is being studied in the form of mini-tablets or tablets. The available information does not explicitly state whether Soticlestat is a known substance in medical literature before this trial. If you wish to know whether Soticlestat is already known to medicine, it might require a more thorough search in medical literature databases outside of the clinical trial data provided.

      Study ID

      CT-EU-00057186

      Recruitment status

      Recruting new patients

      Start of the trial

      2 years ago

      Study phase

      Phase
      III

      Medicinal Product