TAK-861 for Narcolepsy
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.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
How is the drug TAK-861 different from other narcolepsy treatments?
Research Team
Study Director
Principal Investigator
Takeda
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive TAK-861 or placebo for 8 or 12 weeks to evaluate efficacy, safety, and tolerability
Follow-up
Participants are monitored for safety and effectiveness after treatment, with 2 final visits 7 and 28 days after last dose
Open-label extension (optional)
Participants may opt into continuation of treatment with TAK-861 long-term
Treatment Details
Interventions
- Placebo
- TAK-861
Find a Clinic Near You
Who Is Running the Clinical Trial?
Takeda
Lead Sponsor
Dr. Naoyoshi Hirota
Takeda
Chief Medical Officer since 2020
MD from University of Tokyo
Christophe Weber
Takeda
Chief Executive Officer since 2015
PhD in Molecular Biology from Université de Montpellier