Status:
COMPLETED
A Study of TAK-861 in People With Narcolepsy Type 1
Lead Sponsor:
Takeda
Conditions:
Narcolepsy Type 1
Eligibility:
All Genders
16-70 years
Phase:
PHASE3
Brief Summary
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 ar...
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 participants with narcolepsy with cataplexy (narcolepsy type 1 \[NT1\]). The stud...
Eligibility Criteria
Inclusion
- The participant has a body mass index (BMI) within the range 18 to 40 kilograms per meter square (kg/m\^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.
- The participant has greater than or equal to (≥)4 partial or complete episodes of cataplexy/week (WCR).
- 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
- The participant has a current medical disorder, other than narcolepsy with cataplexy, associated with EDS.
- 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).
- The participant has current or recent (within 6 months) gastrointestinal disease that is expected to influence the absorption of drugs.
- The participant has a history of cancer in the past 5 years.
- The participant has a clinically significant history of head injury or head trauma.
- The participant has a history of epilepsy, seizure, or convulsion.
- The participant has any current unstable psychiatric disorder or current active major depressive episode (MDE) or an active MDE in the past 6 months.
Key Trial Info
Start Date :
October 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 4 2025
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT06505031
Start Date
October 8 2024
End Date
June 4 2025
Last Update
September 15 2025
Active Locations (28)
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1
Takeda Site 1
Glebe, New South Wales, Australia
2
Takeda Site 22
Linz, Austria, 4020
3
Takeda Site 2
Alken, Belgium
4
Takeda Site 3
Erpent, Belgium, 5101