Long-term effects and safety of the new drug for narcolepsy

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    What is this study about?

    This study focuses on TAK-861, a drug developed to treat narcolepsy type 1 (NT1) and narcolepsy type 2 (NT2). The research aims to evaluate TAK-861’s safety using 160 volunteers who participated in previous narcolepsy studies. The volunteers will be divided into groups and given different doses of TAK-861, depending on their original dose in the parent study. The drug’s effectiveness in alleviating Narcolepsy symptoms such as excessive daytime sleepiness (EDS) and cataplexy episodes will also be observed. This study is intended to last up to 108 weeks with regular visits to the clinic for check-ups. At the end of the study, volunteers will receive a follow-up assessment four weeks after their last dose. While this exploration into the medicine’s long-term effects serves as a new step towards making advancements in narcolepsy treatment.

    Learn more about this Trial

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      Locations

      Where does the clinical trial take place?

      Helsinki , Finland

      Toulouse , France

      Montpellier , France

      La Tronche , France

      Paris , France

      Regensburg , Germany

      Schwerin , Germany

      Berlin , Germany

      Hamburg , Germany

      Roma , Italy

      Pozzilli , Italy

      Bellaria , Italy

      Heeze , Netherlands

      Heemstede , Netherlands

      Oslo , Norway

      Vitoria , Spain

      Castellu00f3n De La Plana , Spain

      Alzira , Spain

      Barcelona , Spain

      Barcelona , Spain

      Madrid , Spain

      Madrid , Spain

      Goteborg , Sweden

      You can join this study in:

      Study Steps

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

      Patients participating in this clinical trial will be enrolled from controlled studies conducted with TAK-861 and will be assigned to one of the treatment groups based on the dose assigned to them in their parent study. Participants who were previously on a placebo dose will be randomly assigned to one of the treatment groups. All participants will receive the drug TAK-861.

      The doses for participants with Narcolepsy Type 1 (NT1) will range from TAK-861 Dose 1 to Dose 4. Those with Narcolepsy Type 2 (NT2) will receive either TAK-861 Dose 1 or Dose 2 from the parent study. Each participant will receive their assigned dose for up to 104 weeks.

      The overall time to participate in this study is approximately 108 weeks, and there will be multiple visits to the clinic, with some visits potentially conducted by home health services, followed by a follow-up assessment 4 weeks after the last dose of the study drug.


      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      To join the study, you must have a diagnosis of narcolepsy—that includes participants diagnosed with both NT1 (type 1 narcolepsy) or NT2 (type 2 narcolepsy) and have completed a controlled study with TAK-861 .


      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      Inclusion Criteria:

      • The participant must have a diagnosis of narcolepsy and should have completed a controlled study with TAK-861. This includes participants diagnosed with either Narcolepsy Type 1 (NT1) or Narcolepsy Type 2 (NT2).

      Narcolepsy is a long-term neurological disorder that involves a decreased ability to regulate sleep-wake cycles.
      Narcolepsy Type 1 (NT1) is characterized by excessive daytime sleepiness combined with sudden muscle weakness called cataplexy.
      Narcolepsy Type 2 (NT2) also involves excessive daytime sleepiness but without cataplexy.

      What Reasons Could Exclude Me from the Study?

      Exclusion Criteria with Medical Term Explanations:

      1. Ongoing treatment emergent adverse event (TEAE) related to the study drug: If you have moderate or severe side effects from the study drug in the parent study, you cannot participate.

      2. Positive urine screen for drugs of abuse or positive alcohol test: If you tested positive for drugs or alcohol in previous visits or during the screening period, you are ineligible.

      3. Risk of suicide as per the Columbia Suicide Severity Rating Scale (C-SSRS): If you have shown a risk for suicide through certain responses in the C-SSRS in the parent study or during screening, you will be excluded.

      4. Elevated liver enzymes (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]): If your ALT and AST levels are more than 1.5 times the upper limit of normal at multiple visits in the previous study or during screening, and if it is clinically significant.

      5. Current medical disorder associated with excessive daytime sleepiness (other than narcolepsy): If you have another medical condition that causes excessive sleepiness, you cannot participate.

      6. Current or recent major depressive episode (MDE): If you are currently experiencing or have had a major episode of depression in the past 6 months, you are ineligible.

      7. Recent gastrointestinal disease affecting drug absorption: Conditions like malabsorption, acid reflux, ulcer disease, frequent heartburn, or related surgeries in the last 6 months disqualify you.

      8. Epilepsy or history of seizure: If you have epilepsy or have had seizures in the past, you cannot take part.

      9. Need for excluded medications due to certain medical conditions: If you require medications that are not allowed in the trial due to other medical conditions like anxiety, depression, heart disease, or significant hepatic (liver), pulmonary (lung), or renal (kidney) disease, you are not eligible.

      10. Recent cerebral ischemia, transient ischemic attack, or cerebral hemorrhage: A history of certain types of stroke or bleeding in the brain within the last 5 years makes you ineligible.

      11. History of significant heart conditions: Past myocardial infarction, significant coronary artery disease, angina, cardiac rhythm problems, or heart failure exclude you from the study.

      12. History of cancer in the past 5 years: Except for particular types like carcinoma in situ (treated without further intervention) or basal cell skin cancer, a recent history of cancer disqualifies you.


      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The document does not provide information regarding the active substance in TAK-861, nor any trade names associated with it. The study documentation only mentions TAK-861 as the drug being tested, without further chemical or pharmacological details. TAK-861 is being investigated for its safety and potential effectiveness in treating narcolepsy type 1 (NT1) and narcolepsy type 2 (NT2), with outcomes being measured in improvements of narcolepsy symptoms such as excessive daytime sleepiness (EDS) and the frequency of cataplexy episodes.

      To compile a list of active substances and provide their descriptions as requested, further detailed pharmacological information would be required that is not available in the document provided. Normally, details about the molecular structure, mechanism of action, and pharmacodynamics of the drug would be included in the study protocol or Investigator’s Brochure, which are not accessible here.

      Since the study does not offer additional details on the active substance of TAK-861 or any trade names, I’m unable to fulfill your request to provide a list with a brief description of each active substance and their roles in the study. Please let me know if there is anything else I can assist you with.

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

      The active substance participating in the clinical trial is TAK-861. TAK-861 is presented in the form of tablets used in the study. There is no additional information provided in the document about whether TAK-861 is already known to medicine and medical literature.


      Study ID

      CT-EU-00024135

      Recruitment status

      Recruting new patients

      Start of the trial

      1 year ago

      Study phase

      Phase
      II

      Medicinal Product