A Study of TAK-861 for the Treatment of Narcolepsy Type 1
NCT Number: NCT06470828
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Narcolepsy Type 1
Interventions: DRUG: TAK-861|DRUG: Placebo
Sponsor: Takeda
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 152
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-02
Completion Date: 2026-05-23
Locations: Takeda Site 4, Orlando, Florida, 32803-1468, United States|Takeda Site 3, Atlanta, Georgia, 30328, United States|Takeda Site 5, Saint Louis, Missouri, 63123, United States|Takeda Site 2, Denver, North Carolina, 28037, United States|Takeda Site 6, Cincinnati, Ohio, 45227-2172, United States|Takeda Site 1, Columbia, South Carolina, 29201-2923, United States|Takeda Site 7, Kumamoto-shi, Kumamoto-Ken, 861-0954, Japan|Takeda Site 8, Bunkyo-ku, Tokyo, 112-0012, Japan

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 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.

Primary Outcome Measures: Mean Sleep Latency from the MWT at Week 12, 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 done 2 hours apart. Sleep latency in each session will be recorded. Participants will be required to stay awake in between the 4 sessions., Week 12
Secondary Outcome Measures: Epworth Sleepiness Scale (ESS) Total Score at Week 12, 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., Week 12|Weekly Cataplexy Rate (WCR) at Week 12, Week 12|Number of Lapses on the 3 Post Meridiem (PM) Psychomotor Vigilance Test (PVT) Session at Week 12, The PVT is a simple reaction performance task that aims to measure sustained attention. The number of lapses (delayed responses to a visual cue) will be recorded., 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., Week 12|Narcolepsy Severity Scale for Clinical Trials (NSS-CT) Total Score at Week 12, 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., Week 12|Functional Impacts of Narcolepsy Instrument (FINI) Domain Scores at Week 12, 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., Week 12|Short Form-36 Survey (SF-36) Mental and Physical Component Scores at Week 12, 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., 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., Up to 16 weeks