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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
~120

Find a Location

Who is running the clinical trial?

TakedaLead Sponsor
1,202 Previous Clinical Trials
4,177,856 Total Patients Enrolled
8 Trials studying Narcolepsy
829 Patients Enrolled for Narcolepsy
Study DirectorStudy DirectorTakeda
1,210 Previous Clinical Trials
489,329 Total Patients Enrolled
5 Trials studying Narcolepsy
470 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment open to participants aged 50 or above?

"This medical trial requires that enrollees be between 16 and 70 years of age. There are 11 studies available for minors, while 18 separate trials can be accessed by those over 65."

Answered by AI

What criteria must patients meet in order to be eligible for this medical experiment?

"Candidates with narcolepsy who are between 16 and 70 years old may be accepted into this trial. The recruitment process targets 160 participants in total."

Answered by AI

What is the largest population of participants in this medical study?

"Affirmative. Per the clinicaltrials.gov entry, recruitment for this medical study is ongoing; it was initially posted on April 5th 2023 and last modified a few weeks later on the 21st of April. 160 patients are needed at 1 trial site to complete enrolment."

Answered by AI

Are there any spaces available for those who wish to join this trial?

"Affirmative, clinicaltrials.gov data indicates that this medical trial has resumed recruitment efforts since its original posting on April 5th 2023. The last update was done on April 21st 2023 and the researchers are seeking 160 volunteers across a single site."

Answered by AI
~107 spots leftby Dec 2026