A Study of TAK-861 for the Treatment of Selected Central Hypersomnia Conditions

Launched by TAKEDA · Mar 31, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a medication called TAK-861 for individuals with Type 1 Narcolepsy, a condition that causes extreme daytime sleepiness and sudden sleep attacks. The main goal of the study is to assess how safe TAK-861 is and how well people can tolerate it after having previously participated in another study with this drug.

To join the trial, participants need to have a confirmed diagnosis of Type 1 Narcolepsy and must have completed a previous study involving TAK-861 without any serious problems related to the drug. Unfortunately, some individuals may not be eligible if they have experienced severe side effects from past treatments, have certain medical conditions, or have a recent history of serious health issues like heart problems or cancer. Those who qualify will be part of a study where they can contribute to understanding a potential new treatment option for narcolepsy while being closely monitored by healthcare professionals.

Gender

ALL

Eligibility criteria

• Inclusion criteria:
• • 1. Participant with a diagnosis of NT1 who has completed a controlled study with TAK-861, and for whom the investigator has no clinical objection to their enrollment.
• Exclusion criteria:
• • 1. Participant has a treatment-emergent adverse event (TEAE) that remains severe at the time of rollover related to the study drug from the parent study or discontinued because of TEAEs in the parent study.
• • 2. Participant has a risk of suicide according to endorsement of item 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS).
• • 3. The participant has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values \>1.5 times the upper limit of normal (ULN).
• • 4. Participant has a current medical disorder, other than narcolepsy with or without cataplexy, associated with excessive daytime sleepiness (EDS).
• • 5. Participant has current active major depressive episode (MDE) or has had an active MDE in the past 6 months.
• • 6. Participant has developed (within the last 6 months) gastrointestinal disease that is expected to influence the absorption of drugs.
• • 7. Participant has epilepsy or history of seizure.
• • 8. Participant has any other medical condition, such as anxiety, depression, heart disease, or significant hepatic, pulmonary, or renal disease, that requires them to take excluded medications.
• • 9. Participant has a history of cerebral ischemia, transient ischemic attack (\<5 years ago), or cerebral hemorrhage.
• • 10. Participant has a history of myocardial infarction, clinically significant coronary artery disease, clinically significant angina, clinically significant cardiac rhythm abnormality, or heart failure.
• • 11. Participant has a history of cancer in the past 5 years.