A Study of TAK-994 in Adults With Type 1 and Type 2 Narcolepsy
Public ClinicalTrials.gov record NCT04096560. 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, Multiple Rising Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-994 in Patients With Narcolepsy With or Without Cataplexy (Narcolepsy Type 1 or Narcolepsy Type 2)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The main aims of the study are: * To check for side effects from TAK-994 and check what dose of TAK-994 participants can tolerate. * To check what dose range provides adequate relief of narcolepsy symptoms. * To check how much TAK-994 stays in the blood of participants, over time. The study will have 4 parts. Participants can only join 1 of the parts. A. Participants with type 1 narcolepsy will take either TAK-994 or placebo tablets for 28 days. A placebo looks just like TAK-994 but will not have any medicine in it. B. Participants with type 1 narcolepsy will take 1 of 3 doses of TAK-994 or placebo tablets for 56 days. C. Participants with type 1 narcolepsy in China only will take TAK-994 or placebo tablets for 56 days. D. Participants with type 2 narcolepsy will take either TAK-994 or placebo tablets for 28 days.
Study identification
- NCT ID
- NCT04096560
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 97 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 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
- May 27, 2020 (Actual)
- Primary completion
- Nov 5, 2021 (Actual)
- Completion
- Nov 5, 2021 (Actual)
- Last update posted
- Oct 29, 2024
2020 – 2021
United States locations
- U.S. sites
- 36
- U.S. states
- 16
- U.S. cities
- 34
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Wright Clinical Research | Alabaster | Alabama | 35007 | — |
| Mayo Clinic Arizona | Phoenix | Arizona | 85054 | — |
| CITrials - Bellflower | Bellflower | California | 90706 | — |
| Santa Monica Clinical Trials | Los Angeles | California | 90025 | — |
| Stanford School of Medicine | Redwood City | California | 94063 | — |
| Pacific Research Network, Inc | San Diego | California | 92128 | — |
| SDS Clinical Trials, Inc. | Santa Ana | California | 92705 | — |
| Alpine Clinical Research Center | Boulder | Colorado | 80301 | — |
| Delta Waves Sleep Disorders and Research Center | Colorado Springs | Colorado | 80918 | — |
| St. Francis Medical Institute | Clearwater | Florida | 33765 | — |
| Sleep Medicine Specialists of South Florida | Miami | Florida | 33126 | — |
| Clinical Trials of Florida | Miami | Florida | 33186 | — |
| JSV Clinical Research Study, Inc | Tampa | Florida | 33624 | — |
| Florida Pulmonary Research Institute, LLC | Winter Park | Florida | 32789 | — |
| NeuroTrials Research, Inc. | Atlanta | Georgia | 30328 | — |
| iResearch Atlanta, LLC | Decatur | Georgia | 30030 | — |
| Sleep Practitioners, LLC | Macon | Georgia | 31210 | — |
| Global Research Associates | Stockbridge | Georgia | 30281 | — |
| Hawaii Pacific Neuroscience | Honolulu | Hawaii | 96817 | — |
| Lutheran Sleep Disorder Center | Fort Wayne | Indiana | 46804 | — |
| University of Kansas Medical Center Research Institute, Inc. | Kansas City | Kansas | 66160 | — |
| Helene A. Emsellem, MD PC trading as "The Center for Sleep & Wake Disorders" | Chevy Chase | Maryland | 20815 | — |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | — |
| Neurocare, Inc., dba Neurocare Center for Research | Newton | Massachusetts | 02459 | — |
| Research Carolina Elite LLC | Denver | North Carolina | 28037 | — |
| Clinical Research of Gastonia | Gastonia | North Carolina | 28054 | — |
| Raleigh Neurology Associates | Raleigh | North Carolina | 27607 | — |
| CTI Clinical Research Center | Cincinnati | Ohio | 45245 | — |
| Intrepid Research | Cincinnati | Ohio | 45245 | — |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Ohio Sleep Medicine and Neuroscience Institute | Dublin | Ohio | 43017 | — |
| Respiratory Specialists | Wyomissing | Pennsylvania | 19610 | — |
| Medical University of South Carolina (MUSC) | Charleston | South Carolina | 29425 | — |
| Bogan Sleep Consultants, LLC | Columbia | South Carolina | 29201 | — |
| Sleep Therapy & Research Center | San Antonio | Texas | 78229 | — |
| Comprehensive Sleep Medicine Associates | Sugar Land | Texas | 77478 | — |
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 42 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04096560, 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 Oct 29, 2024 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04096560 live on ClinicalTrials.gov.