A Dose-Blind Extension Study With Double-blind, Placebo-Controlled, Randomized Withdrawal Period to Evaluate the Safety and Explore the Pharmacokinetics and Pharmacodynamics of TAK-994 in Adults With Narcolepsy With Cataplexy (Narcolepsy Type 1) - TAK-994 Extension and Randomized Withdrawal Study in Adult Subjects With Narcolepsy Type 1

Takeda Development Center Americas, Inc.0 个研究点目标入组 112 人开始时间: 2021年6月3日最近更新: 2022年3月14日

研究概览

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•Subject eligibility is determined according to the following criteria before entry into the study:
•1. Subject with a diagnosis of NT1 who has completed TAK-994-1501 Part B before enrollment (which will occur immediately following the final TAK-994-1501 assessments), and for whom the investigator has no clinical objection they be enrolled.
•2. Subject is capable of understanding and complying with protocol requirements.
•3. Male subject who is not sterilized and sexually active with a female partner of childbearing potential, must use barrier contraception from signing of informed consent until 5 half-lives of TAK-994 plus 90 days after the last
•dose of study drug. In addition, they must be advised not to donate sperm during this period.
•4. Female subject of childbearing potential who is sexually active with a male partner who is not sterilized, must agree to use highly effective methods of contraception from signing of informed consent until 5 half-lives of TAK-994 plus 30 days after the last dose of study drug. In addition, they must be advised not to donate ova during this period.
•5. Subject must agree to participate by providing written informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 112
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Subject has a clinically significant moderate or severe ongoing adverse event (AE) related to the study drug from the prior study.
•2. Subject has used/uses disallowed concomitant medication.
•3. Subject, in the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any reason.
•4. The subject is an employee of the sponsor or study site or an immediate family member (eg, spouse, parent, child, sibling) of an employee of the sponsor or study site who is directly involved in the conduct of the study.
•5. The subject has a known hypersensitivity to any component of the formulation of TAK-994 or related compounds.
•6. The subject has a positive pregnancy test or is a lactating/breastfeeding woman.
•7. The subject had major surgery or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks before Baseline I (excluding samples taken as part of TAK-994-1501).
•8. The subject’s renal creatinine clearance is =50 mL/min.
•9. Has liver function tests (alanine aminotransferase, aspartate aminotransferase) higher than 1.5 times the upper limit of normal at any visit in TAK-994-1501.
•10. The subject has a risk of suicide according to endorsement of Item 4 or 5 on the Columbia Suicide Severity Rating
•Scale (C-SSRS) at any visit during TAK-994-1501 and/or has made a suicide attempt during TAK-994-1501.

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