A Trial of TAK-861 for the Treatment of Narcolepsy With Cataplexy

The drug being tested in this study is called TAK-861. This study will look at how effective TAK-861 is for the treatment of narcolepsy type 1 and how well this effect is maintained over time. This study also evaluates how safe TAK-861 is and what adverse events may be associated with taking the drug and stopping the drug in participants with NT1.

The study will enroll approximately 88 participants. All participants will take TAK-861 during the open-label (OL) treatment period. Participants who meet certain criteria at the end of the OL Treatment Period will be randomized to one of two treatment groups for the up to 4-week double-blind randomized withdrawal (RW) Period. Participants will be randomized to one of the following treatment groups during the Double-blind RW Period:

1. TAK-861 (same dose participant was taking at the end of the OL Treatment Period) 2. Placebo

The randomized withdrawal period may last up to 4 weeks. Participants whose NT1 symptoms get worse during the RW period and whose Epworth Sleepiness Scale score rises above a certain score will stop the treatment and be invited to continue in a separate long term extension study. Participants who choose not to take part in the extension study will be followed-up for 4 weeks after their last dose of study drug. This multi-center trial will be conducted globally.

• Change From the End of the OL Treatment Period to Week 2 of the RW Period on the Maintenance of Wakefulness Test (MWT) [Срок оценки: From the end of the OL treatment period (Week 16) to Week 2 of the RW period (Week 18)]
• Weekly Cataplexy Rate (WCR) at Week 2 of the RW Period [Срок оценки: Week 2 of the RW period]
• Change from the End of the OL Treatment Period to Week 2 of the RW Period in Mean Number of Lapses on the Psychomotor Vigilance Test (PVT) [Срок оценки: From the end of the OL treatment period (Week 16) to Week 2 of the RW period (Week 18)]
• Number of Participants Reporting Much or Very Much Worse in Patient Global Impression of Change (PGI-C) Score at Week 2 of the RW Period [Срок оценки: Week 2 of the RW period]
• Change from the End of the OL Treatment Period to Week 2 of the RW Period in Narcolepsy Severity Scale for Clinical Trials (NSS-CT) Total Score [Срок оценки: From the end of the OL treatment period (Week 16) to Week 2 of the RW period (Week 18)]
• Change from the End of the OL Treatment Period to Week 2 of the RW Period in Functional Impacts of Narcolepsy Instrument (FINI) Domain Scores [Срок оценки: From the end of the OL treatment period (Week 16) to Week 2 of the RW period (Week 18)]
• Change from the End of the OL Treatment Period to Week 2 of the RW Period in Number of Correct Responses on the International Digit Symbol Substitution Test-symbols (iDSST-s) [Срок оценки: From the end of the OL treatment period (Week 16) to Week 2 of the RW period (Week 18)]
• Number of Participants With At Least One Treatment-Emergent Adverse Event (TEAE) [Срок оценки: From Screening to End of study (approximately 31 weeks)]