A Trial of TAK-861 for the Treatment of Narcolepsy With Cataplexy
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age16-70
SponsorTakeda
About this trial
The main aim of this study is to assess how effective TAK-861 is for treating narcolepsy type 1 and if this effect is maintained over time. Participants will take TAK-861 for a few months and if they meet certain criteria, they will be randomly assigned (by chance, like flipping a coin) to continue taking TAK-861 or take placebo (fake medicine) for up to 4 weeks to see if their narcolepsy symptoms return.
Eligibility criteria
Qualifiers
The participant has a body mass index (BMI) within the range 18 to 40 kilograms per square meter (kg/m²).
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 is positive for the human leukocyte antigen (HLA) genotype Major Histocompatibility Complex, Class II, DQ Beta 1 (HLA-DQB1*06:02) or results from radioimmunoassay indicate the participant's CSF OX/hypocretin-1 concentration is ≤110 pg/mL (or less than one-third of the mean values obtained in normal participants within the same standardized assay).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- TAK-861
- Placebo
Treatment groups
88 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov