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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
168
Change From Baseline to Week 12 in Mean Sleep Latency From the 4 Maintenance of Wakefulness Test (MWT) Wake Trials
The MWT evaluates a person's ability to remain awake under soporific conditions for a defined period of time. Because there is no biological measure of wakefulness, wakefulness is measured indirectly by the inability or delayed tendency to fall asleep. This tendency to fall asleep is measured via electroencephalography-derived sleep latency in the MWT. The MWT consists of four 40-minute sessions (trials) done 2 hours apart. Sleep latency in each session will be recorded. Participants will be required to stay awake in between the 4 sessions.
Time frame: Baseline, Week 12
Change From Baseline to Week 12 in ESS Total Score
The ESS provides individuals with 8 different situations of daily life and asks them how likely they are to fall asleep in those situations (scored 0 to 3) and to try to imagine their likelihood of dozing even if they have not actually been in the identical situation; 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.
Time frame: Baseline, Week 12
Weekly Cataplexy Rate (WCR) at Week 12
Time frame: Week 12
Change From Baseline to Week 12 in Mean Number of Lapses on the 3 Psychomotor Vigilance Test (PVT)
The PVT is a simple reaction performance task that aims to measure sustained attention. The change from baseline in the mean number of lapses (delayed responses to a visual cue from intraday sessions) during the 10 minute test will be used as a measure of objective sustained attention.
Time frame: Baseline, Week 12
Patient Global Impression of Change (PGI-C) Score at Week 12
The PGI-C is a patient self-rated scale to assess improvement in daytime sleepiness and overall narcolepsy symptoms. The PGI-C includes 7 items being scored from 1 (best outcome) to 7 (worst outcome) with 4 being no change.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Takeda Site 48
Phoenix, Arizona, United States
Takeda Site 39
Redwood City, California, United States
Takeda Site 31
Santa Ana, California, United States
Takeda Site 18
Upland, California, United States
Takeda Site 4
Orlando, Florida, United States
Takeda Site 3
Atlanta, Georgia, United States
Takeda Site 45
Boston, Massachusetts, United States
Takeda Site 5
St Louis, Missouri, United States
Takeda Site 2
Denver, North Carolina, United States
Takeda Site 6
Cincinnati, Ohio, United States
...and 43 more locations
Time frame: Week 12
Change From Baseline to Week 12 in Narcolepsy Severity Scale for Clinical Trials (NSS-CT) Total Score
The NSS-CT is a 15-item self-administered questionnaire that assesses the severity and consequences of the 5 major narcolepsy symptoms such as daytime sleepiness, cataplexy, hallucinations, sleep paralysis, and disturbed nighttime sleep (DNS) with a total score range of 0 to 57 (sum of 6 items that assess symptoms severity are rated using a six-point Likert scale \[0-5\] and 9 items that describe the symptom effect on daily life are rated using a four-point Likert scale \[0-3\]). Higher total scores mean a worse outcome.
Time frame: Baseline, Week 12
Change From Baseline to Week 12 in Functional Impacts of Narcolepsy Instrument (FINI) Domain Scores
The FINI measures the functional impacts of narcolepsy across 6 domains. Each domain is scored from 0 to 4, where 0 indicates the best health and 4 the worst.
Time frame: Baseline, Week 12
Change From Baseline to Week 12 in Short Form-36 Survey (SF-36) Mental and Physical Component Scores
The SF-36 is participant-reported survey of participant health that assesses the quality of life and includes both physical and mental components. The scores for each component range from 0 to 100. Higher scores represent better health-related quality of life.
Time frame: Baseline, Week 12
Number of Participants with At Least one Treatment-Emergent Adverse Event (TEAE)
An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product. A TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with a study intervention or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the study intervention or medicinal product.
Time frame: Up to 16 weeks