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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.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am between 18 and 70 years old.I have been diagnosed with narcolepsy type 2 in the last 5 years.I have a condition causing excessive daytime sleepiness, not including narcolepsy without cataplexy.I have had a stroke, mini-stroke, brain aneurysm, or blood vessel malformation in the last 5 years.I have not had major surgery or donated/lost significant blood in the last 4 weeks.I have a history of seizures or epilepsy, or it runs in my family.
- Group 1: TAK-861 Dose 2
- Group 2: TAK-861 Dose 1
- Group 3: Placebo
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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."
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."
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."
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."
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."
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."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
Why did patients apply to this trial?
What questions have other patients asked about this trial?
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Most responsive sites:
- Sleep Disorders Center of Alabama: < 48 hours
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