A Study of TAK-861 for the Treatment of Narcolepsy Type 1
Purpose
The main aim of this study is to learn how effective TAK-861 is in improving excessive sleepiness during the day (called excessive daytime sleepiness or EDS) after 3 months of treatment. Other aims are to learn how effective TAK-861 is in lowering the number of sudden, unexpected attacks of muscle weakness while staying conscious (cataplexy) in a week; to learn the effect TAK-861 has on participants' ability to maintain attention, participant's overall quality of life, the spectrum of narcolepsy symptoms, and daily life functions; and to learn about the safety of TAK-861.
Condition
- Narcolepsy Type 1
Eligibility
- Eligible Ages
- Between 16 Years and 70 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- The participant has a body mass index (BMI) within the range 18 to 40 kilograms per meter square (kg/m^2). 2. The participant has an International Classification of Sleep Disorders, Third Edition (ICSD-3) or International Classification of Sleep Disorders, Third Edition, Text Revision (ICSD-3-TR) diagnosis of NT1. 3. The participant has greater than or equal to (≥)4 partial or complete episodes of cataplexy/week (WCR). 4. The participant is positive for the human leukocyte antigen (HLA) genotype HLA-DQB1*06:02 or results from radioimmunoassay indicate the participant's cerebrospinal fluid (CSF) orexin (OX)/hypocretin-1 concentration is less than or equal to (≤)110 picograms per milliliter (pg/mL) [or less than one-third of the mean values obtained in normal participants within the same standardized assay].
Exclusion Criteria
- The participant has a current medical disorder, other than narcolepsy with cataplexy, associated with EDS. 2. The participant: (a) has a history of myocardial infarction; (b) has a history of clinically significant hepatic disease, thyroid disease, coronary artery disease, cardiac rhythm abnormality or heart failure; or (c) has any medical condition (such as unstable cardiovascular, pulmonary, renal or gastrointestinal disease). 3. The participant has current or recent (within 6 months) gastrointestinal disease that is expected to influence the absorption of drugs. 4. The participant has a history of cancer in the past 5 years. 5. The participant has a clinically significant history of head injury or head trauma. 6. The participant has a history of epilepsy, seizure, or convulsion. 7. The participant has a history of cerebral ischemia, transient ischemic attack (<5 years from screening), intracranial aneurysm, or arteriovenous malformation.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental TAK-861 Dose 1 |
Participants will receive TAK-861 tablets at dose 1, orally, for 12 weeks. |
|
|
Experimental TAK-861 Dose 2 |
Participants will receive TAK-861 tablets at dose 2, orally, for 12 weeks. |
|
|
Placebo Comparator Placebo |
Participants will receive TAK-861-matching placebo tablets, orally, for 12 weeks. |
|
Recruiting Locations
More Details
- NCT ID
- NCT06470828
- Status
- Active, not recruiting
- Sponsor
- Takeda
Detailed Description
The drug being tested in this study is called TAK-861. TAK-861 is being tested to evaluate its efficacy and safety in people with narcolepsy type 1 (NT1). The study will enroll approximately 152 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the three treatment groups: 1. TAK-861 Dose 1 2. TAK-861 Dose 2 3. Placebo The study drug will be administered for 12 weeks. This multi-center trial will be conducted globally.