A Long-term Extension Trial to Evaluate the Safety and Tolerability of TAK-360 in Participants With Selected Central Hypersomnia Conditions

未提供0 个研究点目标入组 500 人开始时间: 待定

适应症

试验速览

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•Participant is willing and able to understand and fully comply with trial procedures and requirements.
•Participant has a confirmed diagnosis of either narcolepsy type 1 (NT1), narcolepsy type 2 (NT2), or idiopathic hypersomnia (IH), and has completed the treatment period of a parent TAK-360 trial.
•Participant has provided informed consent (that is, in writing, documented via a signed and dated informed consent form (ICF) and any required privacy authorization before the initiation of any trial procedures.

•Participant has a positive pregnancy test or is lactating/breastfeeding.
•Participant has a risk of suicide according to endorsement of item 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS).
•The participant has developed a new medical disorder associated with excessive daytime sleep (EDS).
•Participant has developed (within the last 6 months) gastrointestinal disease that is expected to influence the absorption of drugs.
•Participant has developed a new history of seizures.
•Participant has experienced clinically significant head injury, per investigator opinion.
•Participant has developed a history of cerebral ischemia, transient ischemic attack (less than [<] 5 years ago), or cerebral haemorrhage.
•Participant has developed a history of myocardial infarction, clinically significant coronary artery disease, clinically significant angina, clinically significant cardiac rhythm abnormality, or heart failure.
•The participant has been diagnosed with medically significant thyroid disease, known functional hepatic impairment, or other severe chronic medical condition other than the central hypersomnolence disorder.
•Participant has developed a history of cancer in the past 5 years.

发起方

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