Narcolepsy Type 1
Conditions
Keywords
Drug Therapy, Narcolepsy With Cataplexy, NT1
Brief summary
Narcolepsy is a sleep disorder that disrupts a person's regular sleep-wake cycle. It causes extreme sleepiness during the day (called excessive daytime sleepiness \[EDS\]), where a person may fall asleep without warning. Narcolepsy Type 1 (NT1) is a form of the condition in which people also have sudden, unexpected muscle weakness while staying conscious (called cataplexy). The main aim of this study is to learn how safe TAK-360 is and how well adults with NT1 tolerate it. Adults who can participate in the study will have to stop taking their existing medicines for NT1 before study treatment starts. Participants may be randomly (by chance, like drawing names from a hat) assigned to get either TAK-360 or placebo during the treatment period. The placebo looks just like TAK-360 but does not have any medicine in it. After the treatment period, participants can be monitored for another 2 weeks. Participants can restart their usual NT1 treatment after study treatment ends. The participants will have to visit the clinic multiple times during this study.
Interventions
DRUGTAK-360
TAK-360 tablet
DRUGPlacebo
TAK-360 matching placebo tablet
Sponsors
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. The participant has a body mass index within the range 18 to 40 kilograms per meter square (kg/m\^2) (inclusive). 2. The participant has an International Classification of Sleep Disorders, Third Edition (ICSD-3) or ICSD-3 Text Revision diagnosis of NT1. Key
Exclusion criteria
1. The participant has a current medical disorder, other than narcolepsy with cataplexy, associated with excessive daytime sleepiness. 2. The participant: (a) has a history of myocardial infarction; (b) has a history of clinically significant thyroid disease, coronary artery disease, cardiac rhythm abnormality or heart failure. 3. The participant has a clinically significant history of head injury or head trauma. 4. The participant has a history of epilepsy, seizure, or convulsion (except for a single febrile seizure in childhood). 5. The participant has a history of cerebral ischemia, transient ischemic attack (\<5 years from screening), intracranial aneurysm, or arteriovenous malformation. 6. The 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 carcinoma; these participants may be included after approval by the medical monitor). 7. The participant has a positive test result for hepatitis B surface antigen, hepatitis B core antibody, hepatitis C virus antibody, or human immunodeficiency virus (HIV) antibody/antigen at screening. 8. The participant plans to participate in any other interventional trial while participating in TAK-360-2004 or has previously participated in another part in TAK-360-2004. 9. The participant has a known hypersensitivity to any component of the formulation of TAK-360 or related compounds.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Parts A, B and C: Number of Participants With at Least One Treatment-emergent Adverse Events (TEAEs) | Up to approximately 28 weeks | An adverse event (AE) is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of the trial intervention, whether or not the occurrence is considered related to the trial intervention. A TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with a study intervention or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the study intervention or medicinal product. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parts A and B: Change from Baseline in Mean Sleep Latency From the Maintenance of Wakefulness Test (MWT) at Week 6 | Baseline, Week 6 | The MWT evaluates a person's ability to remain awake under soporific conditions for a defined period of time. Because there is no biological measure of wakefulness, wakefulness is measured indirectly by the inability or delayed tendency to fall asleep. |
| Parts A and B: Change from Baseline in Epworth Sleepiness Scale (ESS) Total Score at Week 6 | Baseline, Week 6 | The ESS provides individuals with 8 different situations of daily life and asks them how likely they are to fall asleep in those situations (scored 0 to 3) and to try to imagine their likelihood of dozing even if they have not actually been in the identical situation; the scores are summed to give an overall score of 0 to 24. Higher scores indicate stronger subjective daytime sleepiness, and scores below 10 are considered to be within the reference range. |
| Parts A and B: Weekly Cataplexy Rate (WCR) at Week 6 | Week 6 | — |
Countries
Australia, China, France, Italy, Japan, Spain, United States
Contacts
CONTACTTakeda Contact
STUDY_DIRECTORStudy Director
Takeda
Outcome results
None listed