A Study of TAK-861 in Participants With Narcolepsy Type 1 (NCT05687903) | Clinical Trial Compass
CompletedPhase 2
A Study of TAK-861 in Participants With Narcolepsy Type 1
United States112 participantsStarted 2023-01-09
Plain-language summary
The main aim of this study is to see how TAK-861 works on symptoms of narcolepsy, including excessive daytime sleepiness and cataplexy. Approximately 100 participants will take part in the study across North America, Europe and Asia Pacific.
The treatment (TAK-861 or placebo) will be administered for 8 or 12 weeks. After this treatment period the participant will have the option to participate in a separate, long- term extension study during which all participants will be treated with TAK-861.
Who can participate
Age range16 Years ā 70 Years
SexALL
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Inclusion criteria
ā. The participant is aged 18 to 70 years, inclusive, at the time of signing the informed consent form (ICF).
ā. The participant has body mass index (BMI) within the range 18 to 40 kilogram per square meter \[kg/m\^2\] (inclusive).
ā. The participant has an International Classification of Sleep Disorders, 3rd Edition (ICSD-3) diagnosis of narcolepsy type 1 (NT1) by polysomnography (PSG)/Multiple Sleep Latency Test (MSLT), performed within the past 10 years.
ā. The participant is positive for the human leukocyte antigen (HLA) genotype HLA-DQB1\*06:02 or results from cerebrospinal fluid (CSF) testing indicate the participant's CSF orexin (OX)/hypocretin-1 concentration is \<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
ā. The participant has a current medical disorder, other than narcolepsy with cataplexy, associated with EDS.
ā. The participant has medically significant hepatic or thyroid disease.
ā. 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 cancer).
ā. The participant has clinically significant coronary artery disease, a history of myocardial infarction, clinically significant angina, clinically significant cardiac rhythm abnormality, or heart failure.
ā. The participant has a clinically significant history of head injury or head trauma.
What they're measuring
1
Change From Baseline in the Average Sleep Latency as Determined From the MWT at Week 8
ā. The participant has history of epilepsy, seizure, or convulsion, or has a family history of inherited disorders associated with seizure (except for a single febrile seizure in childhood).
ā. The participant has one or more of the following psychiatric disorders: