Age: Any Age
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Takeda
Prior Safety Data
Trial Summary
What is the purpose of this trial?This trial is testing a new drug called TAK-861 to see if it can help people with narcolepsy feel less sleepy during the day and have fewer episodes of sudden muscle weakness. The study will include about 100 participants from different parts of the world.
Eligibility Criteria
Adults aged 18-70 with narcolepsy type 1 confirmed by sleep tests, a BMI of 18-40 kg/m^2, and specific genetic markers or low levels of the brain hormone orexin. Excluded are those with significant medical conditions like heart disease, liver or thyroid issues, history of cancer within five years (except certain skin cancers), head trauma, seizures, stroke risks, infectious diseases like hepatitis B/C or HIV, poor kidney function or high liver enzyme levels.Participant Groups
The study is testing TAK-861 to see if it improves daytime sleepiness and cataplexy in people with narcolepsy. Participants will randomly receive either TAK-861 or a placebo for up to 12 weeks across various regions globally. Afterward, they may join an extension study where everyone gets TAK-861.
5Treatment groups
Experimental Treatment
Placebo Group
Group I: TAK-861 7 mg QDExperimental Treatment2 Interventions
Participants received TAK-861 7 mg, orally, once daily (QD), from Day 1 to 56. Placebo was given as the second dose.
Group II: TAK-861 2 mg and 5 mgExperimental Treatment1 Intervention
Participants received TAK-861 2 mg followed by 5 mg dose, orally, BID, from Days 1 to 56.
Group III: TAK-861 2 mg BIDExperimental Treatment1 Intervention
Participants received TAK-861 2 mg, orally, BID, from Days 1 to 56.
Group IV: TAK-861 0.5 mg BIDExperimental Treatment1 Intervention
Participants received TAK-861 0.5 milligrams (mg), orally, BID, from Days 1 to 56.
Group V: PlaceboPlacebo Group1 Intervention
Participants received placebo tablets matching TAK-861, orally, twice daily (BID), from Days 1 to 56.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Neurotrials ResearchAtlanta, GA
ARSM Research, LLCHuntersville, NC
University of Kansas Medical Center Research Institute, Inc.Kansas City, KS
Neurocare IncNewton, MA
More Trial Locations
Loading ...
Who is running the clinical trial?
TakedaLead Sponsor