Idiopathic Hypersomnia, Narcolepsy Type 1, Narcolepsy Type 2
Conditions
Interventions
TAK-360 Long Term Extension (LTE) Phase:
Participants will receive TAK-360 for up to approximately 5 years in this trial.
Sponsors
Nonomura Hidenori
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participant is willing and able to understand and fully comply with trial procedures and requirements. 2. 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. 3. 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.
Exclusion criteria
Exclusion criteria: 1. Participant has a positive pregnancy test or is lactating/breastfeeding. 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 developed a new medical disorder associated with excessive daytime sleep (EDS). 4. Participant has developed (within the last 6 months) gastrointestinal disease that is expected to influence the absorption of drugs. 5. Participant has developed a new history of seizures. 6. Participant has experienced clinically significant head injury, per investigator opinion. 7. Participant has developed a history of cerebral ischemia, transient ischemic attack (less than [<] 5 years ago), or cerebral haemorrhage. 8. Participant has developed a history of myocardial infarction, clinically significant coronary artery disease, clinically significant angina, clinically significant cardiac rhythm abnormality, or heart failure. 9. 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. 10. Participant has developed a history of cancer in the past 5 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Number of Participants With at Least 1 Treatment-Emergent Adverse Event (TEAE) Time Frame: Up to approximately 5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.All Participants: Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score Time Frame: Baseline through Year 5 2.All Participants: Change from Baseline in Mean Sleep Latency on the Maintenance of Wakefulness Test (MWT) Time Frame: Baseline through Month 6 3.IH Participants: Change From Baseline in IH Severity Scale (IHSS) Total Score Time Frame: Baseline through Year 5 4.NT1 Participants: Change From Baseline on the Narcolepsy Severity Scale for Clinical Trials (NSS-CT) Time Frame: Baseline through Year 5 5.NT2 Participants: Change From Baseline on the Narcolepsy Severity Scale for Clinical Trials (NSS-2-CT) Time Frame: Baseline, through Year 5 6.NT1 Participants: Change from Baseline in Weekly Cataplexy Rate (WCR) Using the Participant-Reported Cataplexy eDiary Time Frame: Baseline, through Month 24 | — |
Countries
Australia, China, France, Italy, Japan, South Korea, Spain, United States
Contacts
Public ContactContact for Clinical Trial Information
Takeda Pharmaceutical Company Limited
Outcome results
None listed