The main aim is to evaluate the effect of TAK-861 on symptoms of narcolepsy, including excessive daytime sleepiness (EDS) as measured by sleep latency from the Maintenance of Wakefulness Test (MWT). The study will enroll approximately 60 participants and they will be randomly assigned to 3 groups (20 per group) to take one of two different doses of TAK-861 or a placebo. All the participants will receive the treatment for 8 weeks. Participants will be asked to complete some questionnaires during the study. This trial will be conducted in North America, Europe, and Asia Pacific.
The drug being tested in this study is called TAK-861. TAK-861 is being tested to treat people who have narcolepsy without cataplexy \[Narcolepsy Type 2 (NT2)\]. This study will evaluate the efficacy, safety, and tolerability of 2 oral doses of TAK-861. The study will enroll approximately 60 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the three treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need): * TAK-861 Dose 1 * TAK-861 Dose 2 * Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient This is a multi-center trial to be conducted worldwide. The overall time to participate in this study is approximately 18 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
71
TAK-861 placebo matching tablets.
TAK-861 2 mg tablets.
TAK-861 2 mg and 5 mg tablets.
Change From Baseline in the Average Sleep Latency as Determined From the MWT at Week 8
The MWT is a validated, objective measure that evaluates a participant's ability to remain awake under soporific conditions for a defined period. During each MWT session (1 session = 40 minutes), participants were instructed to sit quietly and remain awake for as long as possible. Sleep latency in each session was recorded on EEG. If no sleep was observed according to these rules, then the latency was defined as 40 minutes. The linear mixed effects model for repeated measures (MMRM) was used for analysis.
Time frame: Baseline, Week 8
Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score at Week 8
The ESS is a subjective, self-administered, validated scale (scored 0 to 3) to respond to each of the 8 questions of daily life that asks participants how likely they are to fall asleep in those situations. 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 normal range. The MMRM was used for analysis.
Time frame: Baseline, Week 8
Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE)
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not the occurrence is considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE was defined as an AE whose date of onset occurred on or after the first dose of study drug.
Time frame: From first dose of the study drug up to end of the study (up to 3 months)
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Sleep Disorders Center of Alabama
Birmingham, Alabama, United States
Mayo Clinic Arizona-PPDS
Scottsdale, Arizona, United States
Stanford Center for Sleep Sciences and Medicine
Redwood City, California, United States
SDS Clinical Trials, Inc.
Santa Ana, California, United States
Delta Waves LLC - Hunt - PPDS
Colorado Springs, Colorado, United States
Florida Pediatric Research Institute
Orlando, Florida, United States
Neurotrials Research
Atlanta, Georgia, United States
Georgia Neuro Center
Gainesville, Georgia, United States
Neurocare Inc.
Newton, Massachusetts, United States
Henry Ford Medical Center - Columbus
Novi, Michigan, United States
...and 46 more locations