A Study of TAK-861 in Participants With Narcolepsy Type 2
Public ClinicalTrials.gov record NCT05687916. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-861 for the Treatment of Narcolepsy Without Cataplexy (Narcolepsy Type 2)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The main aim is to evaluate the effect of TAK-861 on symptoms of narcolepsy, including excessive daytime sleepiness (EDS) as measured by sleep latency from the Maintenance of Wakefulness Test (MWT). The study will enroll approximately 60 participants and they will be randomly assigned to 3 groups (20 per group) to take one of two different doses of TAK-861 or a placebo. All the participants will receive the treatment for 8 weeks. Participants will be asked to complete some questionnaires during the study. This trial will be conducted in North America, Europe, and Asia Pacific.
Study identification
- NCT ID
- NCT05687916
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 71 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 16 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 8, 2023
- Primary completion
- Dec 12, 2023
- Completion
- Dec 24, 2023
- Last update posted
- Jan 8, 2025
2023
United States locations
- U.S. sites
- 22
- U.S. states
- 14
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Sleep Disorders Center of Alabama | Birmingham | Alabama | 35213-1966 | — |
| Mayo Clinic Arizona-PPDS | Scottsdale | Arizona | 85259-5452 | — |
| Stanford Center for Sleep Sciences and Medicine | Redwood City | California | 94063 | — |
| SDS Clinical Trials, Inc. | Santa Ana | California | 92705-8519 | — |
| Delta Waves LLC - Hunt - PPDS | Colorado Springs | Colorado | 80918 | — |
| Florida Pediatric Research Institute | Orlando | Florida | 32803-1468 | — |
| Neurotrials Research | Atlanta | Georgia | 30342-1743 | — |
| Georgia Neuro Center | Gainesville | Georgia | 30501-3883 | — |
| Neurocare Inc. | Newton | Massachusetts | 02459 | — |
| Henry Ford Medical Center - Columbus | Novi | Michigan | 48377 | — |
| St. Lukes Sleep Medicine and Research Center | Chesterfield | Missouri | 63017-3406 | — |
| Research Carolina Elite | Denver | North Carolina | 28037 | — |
| ARSM Research, LLC | Huntersville | North Carolina | 28078-5082 | — |
| Tricoastal Narcolepsy and Sleep Disorders Center, PLLC | Cincinnati | Ohio | 45212 | — |
| Intrepid Research | Cincinnati | Ohio | 45227-2172 | — |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Ohio Sleep Medicine Institute | Dublin | Ohio | 43017-3521 | — |
| Medical University of South Carolina - PPDS | Charleston | South Carolina | 29425-5712 | — |
| Bogan Sleep Consultants, LLC | Columbia | South Carolina | 29201-2923 | — |
| Comprehensive Sleep Medicine Associates - Sugar Land | Houston | Texas | 77030-2042 | — |
| Sleep Therapy and Research Center | San Antonio | Texas | 78229-4849 | — |
| Children's Specialty Group | Norfolk | Virginia | 23510-1021 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 34 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05687916, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 8, 2025 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05687916 live on ClinicalTrials.gov.