← Back to Search

Other

TAK-861 for Narcolepsy

Phase 2 & 3
Recruiting
Research Sponsored by Takeda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (parent study); week 10 through week 105 (current lte study)
Awards & highlights

Study Summary

This trial studies the safety of a new drug for people with narcolepsy, a sleep disorder.

Who is the study for?
This trial is for people with narcolepsy who have already taken TAK-861 in earlier studies without serious side effects. They shouldn't have other sleep disorders, major depression recently, digestive issues affecting drug absorption, seizures, significant heart or liver diseases, recent strokes or cancer within the last 5 years.Check my eligibility
What is being tested?
The study tests the safety and tolerability of a drug called TAK-861 on individuals with type 1 and type 2 narcolepsy who participated in previous related trials. It aims to understand how well these patients can handle continued treatment.See study design
What are the potential side effects?
While specific side effects are not listed here, participants will be monitored for any adverse reactions to TAK-861 that they may experience during the trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (parent study); week 10 through week 105 (current lte study)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (parent study); week 10 through week 105 (current lte study) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With at Least One or More Treatment-emergent Adverse Events (TEAEs)
Secondary outcome measures
Change from Baseline in the Parent Study in Epworth Sleepiness Scale (ESS) Total Score
Change from Baseline in the Parent Study in Mean Sleep Latency from the Maintenance of Wakefulness Test (MWT)
Change from Baseline in the Parent Study in Weekly Cataplexy Rate (WCR) Using the Patient-reported Cataplexy Diary for Participants With NT1

Trial Design

4Treatment groups
Experimental Treatment
Group I: TAK-861 Dose 4Experimental Treatment1 Intervention
Participants will receive TAK-861 dose 4 for up to 104 weeks.
Group II: TAK-861 Dose 3Experimental Treatment1 Intervention
Participants will receive TAK-861 dose 3 for up to 104 weeks.
Group III: TAK-861 Dose 2Experimental Treatment1 Intervention
Participants will receive TAK-861 dose 2 for up to 104 weeks.
Group IV: TAK-861 Dose 1Experimental Treatment1 Intervention
Participants will receive TAK-861 dose 1 for up to 104 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TAK-861
2023
Completed Phase 2
~190

Find a Location

Who is running the clinical trial?

TakedaLead Sponsor
1,208 Previous Clinical Trials
4,187,757 Total Patients Enrolled
8 Trials studying Narcolepsy
840 Patients Enrolled for Narcolepsy
Study DirectorStudy DirectorTakeda
1,221 Previous Clinical Trials
499,814 Total Patients Enrolled
5 Trials studying Narcolepsy
481 Patients Enrolled for Narcolepsy

Media Library

TAK-861 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05816382 — Phase 2 & 3
Narcolepsy Research Study Groups: TAK-861 Dose 1, TAK-861 Dose 2, TAK-861 Dose 3, TAK-861 Dose 4
Narcolepsy Clinical Trial 2023: TAK-861 Highlights & Side Effects. Trial Name: NCT05816382 — Phase 2 & 3
TAK-861 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05816382 — Phase 2 & 3
~107 spots leftby Dec 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top