Once-Nightly Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy
Public ClinicalTrials.gov record NCT02720744. 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 Double-blind, Randomized, Placebo Controlled, Two Arm Multi-center Study to Assess the Efficacy and Safety of a Once Nightly Formulation of Sodium Oxybate for Extended-Release Oral Suspension (FT218) for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Subjects With Narcolepsy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to determine whether once-nightly FT218 is safe and effective for the treatment of excessive daytime sleepiness and cataplexy in subjects with narcolepsy.
Study identification
- NCT ID
- NCT02720744
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 212 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 16 Years and older
- 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
- Nov 17, 2016 (Actual)
- Primary completion
- Mar 25, 2020 (Actual)
- Completion
- Mar 25, 2020 (Actual)
- Last update posted
- Mar 22, 2022
2016 – 2020
United States locations
- U.S. sites
- 38
- U.S. states
- 19
- U.S. cities
- 35
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pinnacle Research Group LLC | Anniston | Alabama | 36207 | — |
| University Sleep Disorder Center | Auburn | Alabama | AL 36832 | — |
| Sleep Disorders Center of Alabama | Birmingham | Alabama | 35213 | — |
| Baptist Health Center for Clinical Research | Little Rock | Arkansas | 72205 | — |
| California Center for Sleep Disorders | Alameda | California | 94501 | — |
| Stanford Sleep Medicine | Redwood City | California | 94063 | — |
| SDS Clinical Trials Inc | Santa Ana | California | CA 92705 | — |
| Alpine Research Center | Boulder | Colorado | 80301 | — |
| Yale-New Haven Hospital's Sleep Medicine Center | North Haven | Connecticut | 06473 | — |
| Pulmonary Disease Specialist, PA | Kissimmee | Florida | 34741 | — |
| Sleep Medicine Specialists of South Florida | Miami | Florida | 33176 | — |
| Sleep Medicine Specialist of South Florida | Miami | Florida | FL 33126 | — |
| NeuroMedical Research Institute/Global Research Holdings, LLC | Panama City | Florida | FL 32405 | — |
| FL Pediatric REsearch Institute | Winter Park | Florida | 32789 | — |
| Florida Pulmonary Research Institute LLC | Winter Park | Florida | 32789 | — |
| NeuroTrials Research Inc | Atlanta | Georgia | 30342 | — |
| Sleep Disorders Center of Georgia | Atlanta | Georgia | GA 30342 | — |
| Clinical Research Institute | Stockbridge | Georgia | 30281 | — |
| OSF Healthcare Saint Francis Medical Center | Peoria | Illinois | 61637 | — |
| Fort Wayne Neurological Center | Fort Wayne | Indiana | IN 46804 | — |
| Norton Clinical Research Group | Louisville | Kentucky | KY40218 | — |
| Center for Sleep and Wake Disorders | Chevy Chase | Maryland | 20815 | — |
| Infinity Medical Research | North Dartmouth | Massachusetts | MA 2747 | — |
| Not listed | Chesterfield | Missouri | 63017 | — |
| Not listed | St Louis | Missouri | 63143 | — |
| Northwell Health | New Hyde Park | New York | NY 1040 | — |
| Clinilabs Drug Development Corporation | New York | New York | NY10019 | — |
| Montefiore Sleep-Wake Disorders Center | The Bronx | New York | 10467 | — |
| Research Carolina of Huntersville | Huntersville | North Carolina | 28078 | — |
| Wake Research Associates, LLC | Raleigh | North Carolina | NC 27612 | — |
| Sleep Management Institute Intrepid Research | Cincinnati | Ohio | 45245 | — |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | — |
| Ohio Sleep Medicine Institute | Dublin | Ohio | 43017 | — |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | — |
| Medical University of South Carolina - Institute of Psychiatry | Charleston | South Carolina | SC 29425 | — |
| SleepMed Of South Carolina | Columbia | South Carolina | 29201 | — |
| Sleep and Neurology Consultants | Houston | Texas | 77063 | — |
| Sleep Therapy Research Center | San Antonio | Texas | 78229 | — |
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 19 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02720744, 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 Mar 22, 2022 · 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 NCT02720744 live on ClinicalTrials.gov.