Narcolepsy with Cataplexy (Type 1) and Narcolepsy without Cataplexy (Type 2) MedDRA version: 20.0 Level: PT Classification code 10028713 Term: Narcolepsy System Organ Class: 10029205 - Nervous system disorders
Conditions
Sponsors
Takeda Development Center Americas, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participant with a diagnosis of narcolepsy who has completed a controlled study with TAK-861 (including participants diagnosed with NT1 or NT2) and for whom the investigator has no clinical objection to their enrollment. 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 135 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: 1. Participant has a moderate or severe ongoing treatment emergent adverse event (TEAE) related to the study drug from the parent study or discontinued because of TEAEs in the parent study. 2. Participant has a positive urine screen for drugs of abuse (findings confirmed) and/or positive alcohol test during any visit in their prior TAK-861 study, or during the screening period for participants with a dosing gap. 3. Participant has a risk of suicide according to endorsement of item 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS) on any visit in the parent TAK-861 study, or has positive answers on item 4 or 5 on the Screening/Baseline C-SSRS Lifetime (based on the past year) during the screening assessment for participants with a dosing gap. 4. Participant has alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >1.5 times the upper limit of normal (ULN) at multiple visits in the parent study and the findings are of clinical significance, per investigator or sponsor opinion, or ALT/AST >1.5 times ULN during the screening period for participants with a dosing gap. 5. Participant has a current medical disorder, other than narcolepsy with or without cataplexy, associated with excessive daytime sleepiness (EDS). 6. Participant has current active major depressive episode (MDE) or has had an active MDE in the past 6 months. 7. Participant has developed (within the last 6 months) gastrointestinal disease that is expected to influence the absorption of drugs (i.e., a history of malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis, frequent [more than once per week] occurrence of heartburn, or any surgical intervention). 8. Participant has epilepsy or history of seizure. 9. 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. 10. Participant has a history of cerebral ischemia, transient ischemic attack (<5 years ago), or cerebral hemorrhage. 11. Participant has a history of myocardial infarction, clinically significant coronary artery disease, clinically significant angina, clinically significant cardiac rhythm abnormality, or heart failure. 12. Participant has a history of cancer in the past 5 years (does not apply to participants with carcinoma in situ that has been resolved without further treatment, or basal cell skin cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To evaluate the long-term safety and tolerability of TAK-861.;Secondary Objective: • To assess the effect of TAK-861 on excessive daytime sleepiness (EDS) as assessed by the mean sleep latency from the Maintenance of Wakefulness Test(MWT) • To assess the effect of TAK-861 on EDS as measured by the Epworth Sleepiness Scale (ESS) total score. • To assess the effect of TAK-861 on cataplexy as assessed by the weekly cataplexy rate (WCR) (participants with narcolepsy type 1 [NT1] only).;Primary end point(s): • Occurrence of at least 1 treatment-emergent adverse event (TEAE).;Timepoint(s) of evaluation of this end point: Day 395, 425, 485, 515, 575, 605, 665, 695 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Change from baseline in the parent study in MWT mean sleep latency. • Change from baseline in the parent study in ESS total score • Change from baseline in the parent study in WCR using the patient-reported cataplexy diary (participants with NT1 only);Timepoint(s) of evaluation of this end point: - Day 182 - Day 14, 28, 56, 84, 182, 266, 364, 448, 546, 630. 728 - Day 70 to 84; 167 to 181; 252 to 266; 350 to 364; 532 to 546; 714 to 728; 729 to 736 | — |
Countries
Australia, Finland, France, Germany, Italy, Japan, Netherlands, Norway, Spain, Sweden, Switzerland, United States
Contacts
Public ContactStudy Registration Call Center
Takeda Development Center Americas, Inc.
Outcome results
None listed