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TAK-861 for Narcolepsy

Phase 3
Recruiting
Research Sponsored by Takeda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant has a diagnosis of NT1 according to ICSD-3 or ICSD-3-TR
Participant has ≥4 partial or complete episodes of cataplexy/week
Must not have
Participant has a history of cerebral ischemia, transient ischemic attack (<5 years from screening), intracranial aneurysm, or arteriovenous malformation
Participant has a history of epilepsy, seizure, or convulsion
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 16 weeks
Awards & highlights

Summary

"This trial aims to determine how well TAK-861 can reduce excessive daytime sleepiness and sudden muscle weakness attacks in patients with narcolepsy. It will also assess the impact of TAK-861

Who is the study for?
This trial is for individuals with Narcolepsy Type 1, who often feel extremely sleepy during the day or have sudden muscle weakness. Participants should be looking to improve these symptoms and their overall quality of life.
What is being tested?
The study tests TAK-861's effectiveness in reducing daytime sleepiness and muscle weakness episodes over three months. It also examines attention span, life quality, symptom range, and daily function compared to a placebo.
What are the potential side effects?
While specific side effects of TAK-861 are not listed here, common ones may include headache, nausea, dizziness, insomnia or other sleep disturbances. Safety will be monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Narcolepsy Type 1.
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I experience 4 or more episodes of sudden muscle weakness a week.
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I am positive for a specific genetic marker or have low levels of a certain brain hormone.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a stroke, mini-stroke, brain aneurysm, or blood vessel malformation in the last 5 years.
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I have a history of seizures or epilepsy.
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I have a condition causing excessive daytime sleepiness, not including narcolepsy with cataplexy.
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I have a history of heart, liver, thyroid, or serious digestive problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean Sleep Latency from the MWT at Week 12
Secondary study objectives
Epworth Sleepiness Scale (ESS) Total Score at Week 12
Functional Impacts of Narcolepsy Instrument (FINI) Domain Scores at Week 12
Narcolepsy Severity Scale for Clinical Trials (NSS-CT) Total Score at Week 12
+4 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: TAK-861 Dose 2Experimental Treatment1 Intervention
Participants will receive TAK-861 tablets at dose 2, orally, for 12 weeks.
Group II: TAK-861 Dose 1Experimental Treatment1 Intervention
Participants will receive TAK-861 tablets at dose 1, orally, for 12 weeks.
Group III: PlaceboPlacebo Group1 Intervention
Participants will receive TAK-861-matching placebo tablets, orally, for 12 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
1,227 Previous Clinical Trials
4,222,353 Total Patients Enrolled
10 Trials studying Narcolepsy
1,433 Patients Enrolled for Narcolepsy
Study DirectorStudy DirectorTakeda
1,252 Previous Clinical Trials
504,227 Total Patients Enrolled
7 Trials studying Narcolepsy
1,074 Patients Enrolled for Narcolepsy
~101 spots leftby May 2026
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