Phase 2
N=112
A Study of TAK-861 in Participants With Narcolepsy Type 1
Narcolepsy Type 1
Bottom Line
View on ClinicalTrials.gov: NCT05687903 ↗Enrolled (actual)
112
Serious AEs
0.9%
Results posted
Jan 2025
Primary outcome: Primary: Change From Baseline in the Average Sleep Latency as Determined From the MWT at Week 8 — -1.16; 12.49; 23.50; 25.42 minutes — p==0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- TAK-861 (Drug); Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Average Sleep Latency as Determined From the MWT at Week 8 |
-1.16; 12.49; 23.50; 25.42; 14.96 | =0.001 sig |
| SECONDARY Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score at Week 8 |
-2.50; -8.92; -13.79; -12.81; -11.29 | =0.004 sig |
| SECONDARY Weekly Cataplexy Rate (WCR) at Week 8 |
8.76; 4.24; 3.14; 2.48; 5.89 | =0.250 |
| SECONDARY Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE) |
7; 13; 15; 21; 21 | — |
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.
Eligibility Criteria
Inclusion Criteria
- The participant is aged 18 to 70 years, inclusive, at the time of signing the informed consent form (ICF).
Note: In Japan, participants aged 16 to 70 years, inclusive, may be included.
- The participant has body mass index (BMI) within the range 18 to 40 kilogram per square meter [kg/m^2] (inclusive).
- 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.
- 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 1.5 times the upper limit of normal (ULN).
- The participant is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property, or the participant has attempted suicide within the past year.
Data sourced from ClinicalTrials.gov (NCT05687903). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.