An Open-Label Extension Study of DS-5565 for 52 Weeks in Pain Associated With Fibromyalgia
Public ClinicalTrials.gov record NCT02234583. 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
An Open-label Extension Study of DS-5565 for 52 Weeks in Pain Associated With Fibromyalgia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is an open-label study of DS-5565 in subjects who either completed participation in a preceding Phase 3 study of DS-5565 in fibromyalgia (FM); i.e. DS5565-A-E309 (NCT02146430), DS5565-A-E310 (NCT02187471), or DS5565-A-E311 (NCT02187159) or are de novo subjects. Eligible subjects will be assigned to receive open-label DS-5565 for 52 weeks. All subjects will receive DS-5565 15 mg once daily (QD) for the first three weeks of the treatment period. After three weeks, subjects may be titrated to 15 mg twice daily (BID) based on protocol-specified criteria.
Study identification
- NCT ID
- NCT02234583
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 2,485 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 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
- Feb 4, 2015 (Actual)
- Primary completion
- Apr 19, 2017 (Actual)
- Completion
- Apr 19, 2017 (Actual)
- Last update posted
- Jul 23, 2020
2015 – 2017
United States locations
- U.S. sites
- 117
- U.S. states
- 34
- U.S. cities
- 114
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Birmingham | Alabama | 35242 | — |
| Not listed | Mobile | Alabama | 36608 | — |
| Not listed | Phoenix | Arizona | 85018 | — |
| Not listed | Anaheim | California | 92801 | — |
| Not listed | Fresno | California | 93710 | — |
| Not listed | Fresno | California | 93720 | — |
| Not listed | Los Alamitos | California | 90720 | — |
| Not listed | Los Angeles | California | 90036 | — |
| Not listed | Newport Beach | California | 92660 | — |
| Not listed | Rancho Mirage | California | 92270 | — |
| Not listed | Roseville | California | 95661 | — |
| Not listed | San Diego | California | 92103 | — |
| Not listed | Santa Ana | California | 92705 | — |
| Not listed | Santa Barbara | California | 93108 | — |
| Not listed | Santa Monica | California | 90404 | — |
| Not listed | Spring Valley | California | 91978 | — |
| Not listed | Thousand Oaks | California | 91360 | — |
| Not listed | Tustin | California | 92780 | — |
| Not listed | Walnut Creek | California | 94598 | — |
| Not listed | Cromwell | Connecticut | 06416 | — |
| Not listed | Bradenton | Florida | 34201 | — |
| Not listed | Brandon | Florida | 33511 | — |
| Not listed | Brooksville | Florida | 34601 | — |
| Not listed | Clearwater | Florida | 33761 | — |
| Not listed | Clearwater | Florida | 33765 | — |
| Not listed | Coral Springs | Florida | 33067 | — |
| Not listed | Fort Lauderdale | Florida | 33308 | — |
| Not listed | Fort Myers | Florida | 33912 | — |
| Not listed | Hialeah | Florida | 33013 | — |
| Not listed | Jacksonville | Florida | 32256 | — |
| Not listed | Kissimmee | Florida | 34744 | — |
| Not listed | Lakeland | Florida | 33805 | — |
| Not listed | Leesburg | Florida | 34748 | — |
| Not listed | Miami | Florida | 33140 | — |
| Not listed | New Port Richey | Florida | 34652 | — |
| Not listed | Ocala | Florida | 34471 | — |
| Not listed | Orlando | Florida | 32801 | — |
| Not listed | Ormond Beach | Florida | 32174 | — |
| Not listed | Royal Palm Beach | Florida | 33411 | — |
| Not listed | St. Petersburg | Florida | 33709 | — |
| Not listed | Sunrise | Florida | 33351 | — |
| Not listed | Tampa | Florida | 33606 | — |
| Not listed | Alpharetta | Georgia | 30005 | — |
| Not listed | Atlanta | Georgia | 30342 | — |
| Not listed | Columbus | Georgia | 31909 | — |
| Not listed | Savannah | Georgia | 31405 | — |
| Not listed | Smyrna | Georgia | 30080 | — |
| Not listed | Bolingbrook | Illinois | 60490 | — |
| Not listed | Chicago | Illinois | 60634 | — |
| Not listed | Gurnee | Illinois | 60031 | — |
| Not listed | Melrose Park | Illinois | 60160 | — |
| Not listed | Oak Brook | Illinois | 60523 | — |
| Not listed | Evansville | Indiana | 47714 | — |
| Not listed | Indianapolis | Indiana | 46260 | — |
| Not listed | West Des Moines | Iowa | 50265 | — |
| Not listed | Newton | Kansas | 67114 | — |
| Not listed | Shawnee Mission | Kansas | 66218 | — |
| Not listed | Wichita | Kansas | 67205 | — |
| Not listed | Wichita | Kansas | 67207 | — |
| Not listed | Lexington | Kentucky | 40509 | — |
| Not listed | Paducah | Kentucky | 42003 | — |
| Not listed | Lake Charles | Louisiana | 70601 | — |
| Not listed | Boston | Massachusetts | 02131 | — |
| Not listed | Fall River | Massachusetts | 02720 | — |
| Not listed | New Bedford | Massachusetts | 02740 | — |
| Not listed | Watertown | Massachusetts | 02472 | — |
| Not listed | Biloxi | Mississippi | 39531 | — |
| Not listed | Hazelwood | Missouri | 63042 | — |
| Not listed | Kansas City | Missouri | 64114 | — |
| Not listed | Springfield | Missouri | 65807 | — |
| Not listed | St Louis | Missouri | 63141 | — |
| Not listed | Billings | Montana | 59102 | — |
| Not listed | Omaha | Nebraska | 68114 | — |
| Not listed | Las Vegas | Nevada | 89123 | — |
| Not listed | Berlin | New Jersey | 08009 | — |
| Not listed | Blackwood | New Jersey | 08012 | — |
| Not listed | Albuquerque | New Mexico | 87109 | — |
| Not listed | Brooklyn | New York | 11230 | — |
| Not listed | Manhasset | New York | 11030 | — |
| Not listed | New York | New York | 10168 | — |
| Not listed | North Massapequa | New York | 11758 | — |
| Not listed | Charlotte | North Carolina | 28210 | — |
| Not listed | Greensboro | North Carolina | 27408 | — |
| Not listed | High Point | North Carolina | 27262 | — |
| Not listed | Raleigh | North Carolina | 27612 | — |
| Not listed | Winston-Salem | North Carolina | 27103 | — |
| Not listed | Fargo | North Dakota | 58103 | — |
| Not listed | Cincinnati | Ohio | 45242 | — |
| Not listed | Dayton | Ohio | 45417 | — |
| Not listed | Kettering | Ohio | 45429 | — |
| Not listed | Tiffin | Ohio | 44863 | — |
| Not listed | Willoughby | Ohio | 44094 | — |
| Not listed | Oklahoma City | Oklahoma | 73103 | — |
| Not listed | Tulsa | Oklahoma | 74104 | — |
| Not listed | Eugene | Oregon | 97404 | — |
| Not listed | Medford | Oregon | 97504 | — |
| Not listed | Portland | Oregon | 97210 | — |
| Not listed | Salem | Oregon | 97301 | — |
| Not listed | Tipton | Pennsylvania | 16684 | — |
| Not listed | Wyomissing | Pennsylvania | 19610 | — |
| Not listed | Anderson | South Carolina | 29621 | — |
| Not listed | Fountain Inn | South Carolina | 29644 | — |
| Not listed | Greer | South Carolina | 29651 | — |
| Not listed | Dakota Dunes | South Dakota | 57049 | — |
| Not listed | Rapid City | South Dakota | 57702 | — |
| Not listed | Knoxville | Tennessee | 37919 | — |
| Not listed | New Tazewell | Tennessee | 37836 | — |
| Not listed | Tullahoma | Tennessee | 37388 | — |
| Not listed | Dallas | Texas | 75230 | — |
| Not listed | Lubbock | Texas | 79424 | — |
| Not listed | Plano | Texas | 75093 | — |
| Not listed | San Antonio | Texas | 78232 | — |
| Not listed | Salt Lake City | Utah | 84102 | — |
| Not listed | Virginia Beach | Virginia | 23454 | — |
| Not listed | Bellevue | Washington | 98007 | — |
| Not listed | Seattle | Washington | 98104 | — |
| Not listed | Wenatchee | Washington | 98801 | — |
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 159 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02234583, 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 Jul 23, 2020 · Synced Oct 27, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02234583 live on ClinicalTrials.gov.