TAK-861 Dose 2 for Narcolepsy

Phase-Based Progress Estimates
Intrepid Research, Cincinnati, OHNarcolepsyTAK-861 - Drug
16 - 70
All Sexes
What conditions do you have?

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.

Eligible Conditions
  • Narcolepsy Type 2

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: From baseline up to approximately 12 weeks

Baseline, Week 8
Change from Baseline to Week 8 in Epworth Sleepiness Scale (ESS) Total Score
Change from Baseline to Week 8 in Mean Sleep Latency From the Maintenance of Wakefulness Test (MWT)
Week 12
Percentage of Participants who Experience at Least one Treatment Emergent Adverse Event (TEAE)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

3 Treatment Groups

TAK-861 Dose 2
1 of 3
TAK-861 Dose 1
1 of 3
1 of 3

Experimental Treatment

Non-Treatment Group

60 Total Participants · 3 Treatment Groups

Primary Treatment: TAK-861 Dose 2 · Has Placebo Group · Phase 2

TAK-861 Dose 2
Experimental Group · 1 Intervention: TAK-861 · Intervention Types: Drug
TAK-861 Dose 1
Experimental Group · 1 Intervention: TAK-861 · Intervention Types: Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline up to approximately 12 weeks

Who is running the clinical trial?

TakedaLead Sponsor
1,135 Previous Clinical Trials
4,063,436 Total Patients Enrolled
7 Trials studying Narcolepsy
757 Patients Enrolled for Narcolepsy
Study DirectorStudy DirectorTakeda
1,089 Previous Clinical Trials
483,484 Total Patients Enrolled
4 Trials studying Narcolepsy
398 Patients Enrolled for Narcolepsy

Eligibility Criteria

Age 16 - 70 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.