← Back to Search

Placebo

TAK-861 for Narcolepsy

Phase 2
Waitlist Available
Research Sponsored by Takeda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The participant is aged 18 to 70 years, inclusive, at the time of signing the informed consent form (ICF). (Note: In Japan, participants aged 16 to 70 years, inclusive, may be included.)
The participant has an International Classification of Sleep Disorders, 3rd edition (ICSD-3) diagnosis of NT2 by preceding polysomnography (PSG)/ multiple sleep latency test (MSLT), performed within the past 5 years. (Note: If there is a potential participant with NT2 for whom a diagnostic nocturnal polysomnography (nPSG)/MSLT was performed more than 5 years ago or is not available, the site may repeat the diagnostic PSG/MSLT.)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline up to approximately 12 weeks
Awards & highlights

Study Summary

This trial will test a new treatment for narcolepsy to see if it helps reduce excessive daytime sleepiness. It will involve 60 people in 3 groups (20 each) in North America, Europe, and Asia Pacific.

Who is the study for?
Adults aged 18-70 with a diagnosis of Narcolepsy Type 2 (NT2) can join this trial. They must have had a sleep study in the last 5 years confirming NT2, or they may undergo another one if needed. People with other disorders causing excessive daytime sleepiness, certain psychiatric conditions, substance use disorders, or recent major surgery are not eligible.Check my eligibility
What is being tested?
The trial is testing TAK-861 to see if it helps with narcolepsy symptoms like staying awake during the day. Participants will be randomly placed into three groups to receive either TAK-861 at two different doses or a placebo for eight weeks and complete questionnaires about their condition.See study design
What are the potential side effects?
While specific side effects of TAK-861 aren't listed here, common side effects for narcolepsy medications can include headache, nausea, dizziness, and irritability. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 70 years old.
Select...
I have been diagnosed with narcolepsy type 2 within the last 5 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline up to approximately 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline up to approximately 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline to Week 8 in Mean Sleep Latency From the Maintenance of Wakefulness Test (MWT)
Secondary outcome measures
Change from Baseline to Week 8 in Epworth Sleepiness Scale (ESS) Total Score
Percentage of Participants who Experience at Least one Treatment Emergent Adverse Event (TEAE)

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: TAK-861 Dose 2Experimental Treatment1 Intervention
TAK-861 dose 2, orally for 8 weeks.
Group II: TAK-861 Dose 1Experimental Treatment1 Intervention
TAK-861 dose 1, orally for 8 weeks.
Group III: PlaceboPlacebo Group1 Intervention
TAK-861 matching placebo tablets, orally for 8 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
1,194 Previous Clinical Trials
4,178,444 Total Patients Enrolled
8 Trials studying Narcolepsy
929 Patients Enrolled for Narcolepsy
Study DirectorStudy DirectorTakeda
1,193 Previous Clinical Trials
489,629 Total Patients Enrolled
5 Trials studying Narcolepsy
570 Patients Enrolled for Narcolepsy

Media Library

Placebo (Placebo) Clinical Trial Eligibility Overview. Trial Name: NCT05687916 — Phase 2
Narcolepsy Research Study Groups: TAK-861 Dose 1, TAK-861 Dose 2, Placebo
Narcolepsy Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05687916 — Phase 2
Placebo (Placebo) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05687916 — Phase 2

Frequently Asked Questions

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

Is the population for this medical study limited to those of a certain age group?

"According to the study's prerequisites, eligible participants must be aged between 16 and 70. Additionally, there are 8 trials specifically targeting minors under 18 years of age and 9 for those over 65."

Answered by AI

What is the maximum enrollment capacity for this clinical trial?

"Takeda, the sponsor of this study, needs 60 eligible patients to complete it. For their convenience, they are offering participation at SDS Clinical Trials Inc in Santa Ana and Delta Waves LLC - Hunt - PPDS in Colorado Springs."

Answered by AI

Are there any enrollment slots available for this research program?

"Affirmative. Records on clinicaltrials.gov demonstrate that the trial, which was first posted on January 9th 2023, is still enrolling participants. To complete the study, 60 individuals must be sourced from 7 sites across the country."

Answered by AI

How many establishments are managing this research project?

"Presently, the trial is operating at 7 different sites in Santa Ana, Colorado Springs and Orlando as well as four additional locales. Whenever possible, it's beneficial to choose a nearby location so you don't have to travel too far if you decide to join this study."

Answered by AI

Has the first dose of TAK-861 been authorized for general use by the FDA?

"After conducting a risk assessment, our team at Power believes that TAK-861 Dose 1 is comparatively safe and has rated it with a score of 2. This appraisal is based on the fact that this trial is in Phase 2; while there have been some studies supporting its safety, none attest to its efficacy."

Answered by AI

Do I fulfill the criteria to become part of this medical experiment?

"This clinical trial is seeking 60 participants with narcolepsy type 2 that are aged 16 to 70. Eligibility criteria include: In Japan, individuals ages 16-70 may be included; Globally, you must be over 18 and below the age of 70 when signing the informed consent form (ICF); Must have an International Classification of Sleep Disorders 3rd edition diagnosis for NT2 by a prior polysomnography/ multiple sleep latency test within 5 years; If this diagnostic was conducted more than five years ago or not available, then the PSG/MSLT will need to be repeated at the site."

Answered by AI

Who else is applying?

What state do they live in?
Alabama
What site did they apply to?
Henry Ford Medical Center - Columbus
Children's Specialty Group
Sleep Disorders Center of Alabama
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

I have tried a frankly ludicrous number of medications to attempt to treat my narcolepsy symptoms. By far the most effective has been xyrem/xywav but both give me significant side effects which reduce my motivation to the point where i feel like a zombie. I would love to find an alternative that would actually allow me to get restful sleep without taking xyrem/xywav.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

Is there any compensation for this study? How long would I have to spend in at the hospital and for how many days?
PatientReceived 1 prior treatment

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Phone Call
Most responsive sites:
  1. Sleep Disorders Center of Alabama: < 48 hours
~7 spots leftby May 2024