Study Summary
This trial will test a new drug (TAK-861) to see if it can help reduce symptoms of narcolepsy. 100 people worldwide will take part in the trial.
- Narcolepsy Type 1
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 3 Secondary · Reporting Duration: Baseline up to approximately 16 weeks
Trial Safety
Safety Progress
Trial Design
5 Treatment Groups
TAK-861 Dose 2
1 of 5
TAK-861 Dose 1
1 of 5
TAK-861 Dose 3
1 of 5
TAK-861 Dose 4
1 of 5
Placebo
1 of 5
Experimental Treatment
Non-Treatment Group
100 Total Participants · 5 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 · 5 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Frequently Asked Questions
Does the age cutoff for enrollment in this trial extend to younger than 30 years old?
"This medical study is open to individuals aged 16-70. Separate clinical trials are available for those under 18 and above 65 years old, comprising 8 and 9 respectively." - Anonymous Online Contributor
Has the FDA sanctioned TAK-861 Dose 2?
"While there is some proof of safety, no evidence of efficacy exists for TAK-861 Dose 2. Therefore, on our scale from 1 to 3 it receives a score of two." - Anonymous Online Contributor
How many participants are currently participating in this medical experiment?
"For this project to succeed, a pool of 100 qualified participants must be recruited. Potential volunteers can join from either SDS Clinical Trials in Santa Ana or Delta Waves LLC - Hunt - PPDS in Colorado Springs." - Anonymous Online Contributor
Is this research project currently recruiting new participants?
"Affirmative, the information on clinicaltrials.gov reveals that this research is in need of participants. It was initially posted January 9th 2023 and most recently modified on January 31st 2023. The study requires 100 individuals to be enrolled at 7 individual sites." - Anonymous Online Contributor
In which healthcare facilities is this study being conducted?
"The experiment is presently running across 7 different sites, including Santa Ana, Colorado Springs and Orlando. It's advised that a participant choose the closest location to them in order to reduce travelling requirements." - Anonymous Online Contributor
Is enrollment for this medical trial open to me?
"This clinical trial will be recruiting 100 individuals aged 16 to 70, suffering from narcolepsy type 1. Applicants must have a BMI of 18-40 kg/m^2 and the HLA genotype HLA-DQB1*06:02 or CSF orexin concentration <110 pg/mL." - Anonymous Online Contributor