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.
- Narcolepsy Type 2
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 2 Secondary · Reporting Duration: From baseline up to approximately 12 weeks
Trial Safety
Safety Progress
Trial Design
3 Treatment Groups
TAK-861 Dose 2
1 of 3
TAK-861 Dose 1
1 of 3
Placebo
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
Trial Logistics
Trial Timeline
Who is running the clinical trial?
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
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
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
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
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
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