A Study to Test the Effectiveness and Safety of Fremanezumab on Participants With Fibromyalgia
Public ClinicalTrials.gov record NCT03965091. 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 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Proof of Concept Study of the Efficacy and Safety of Fremanezumab for Treatment of Patients With Fibromyalgia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of the study is to estimate the treatment effect of fremanezumab administered subcutaneously (SC) in reducing pain in adult participants with fibromyalgia (FM). A secondary objective is to evaluate the effect of fremanezumab on other efficacy measures, including pain, quality of life, sleep, fatigue, improvement in health, physical functioning, and mood. Another secondary objective is to evaluate the safety and tolerability of fremanezumab administered SC in adult participants with FM. The total duration of participant participation in the study is planned to be 21 weeks, consisting of a screening period of up to 5 weeks (ranging from 17 to 35 days), and a double-blind treatment period of 16 weeks.
Study identification
- NCT ID
- NCT03965091
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 189 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 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
- Jul 31, 2019 (Actual)
- Primary completion
- Jan 19, 2022 (Actual)
- Completion
- Jan 19, 2022 (Actual)
- Last update posted
- Mar 30, 2023
2019 – 2022
United States locations
- U.S. sites
- 49
- U.S. states
- 26
- U.S. cities
- 46
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Teva Investigational Site 14159 | Birmingham | Alabama | 35216 | — |
| Teva Investigational Site 14174 | Huntsville | Alabama | 35801 | — |
| Teva Investigational Site 14431 | Mesa | Arizona | 85210 | — |
| Teva Investigational Site 14166 | Oceanside | California | 92056-4515 | — |
| Teva Investigational Site 14435 | Panorama City | California | 91402 | — |
| Teva Investigational Site 14168 | Sacramento | California | 95831 | — |
| Teva Investigational Site 14164 | San Diego | California | 92103 | — |
| Teva Investigational Site 14172 | Torrance | California | 90502 | — |
| Teva Investigational Site 14433 | Stamford | Connecticut | 06905 | — |
| Teva Investigational Site 14149 | Ocala | Florida | 34470 | — |
| Teva Investigational Site 14180 | Oldsmar | Florida | 34677 | — |
| Teva Investigational Site 14182 | Plantation | Florida | 33317 | — |
| Teva Investigational Site 14162 | Tampa | Florida | 33613-3923 | — |
| Teva Investigational Site 14434 | Marietta | Georgia | 30060 | — |
| Teva Investigational Site 14148 | Chicago | Illinois | 60634 | — |
| Teva Investigational Site 14436 | Flossmoor | Illinois | 60422 | — |
| Teva Investigational Site 14155 | Evansville | Indiana | 47714 | — |
| Teva Investigational Site 14176 | Overland Park | Kansas | 66210 | — |
| Teva Investigational Site 14160 | Wichita | Kansas | 67205 | — |
| Teva Investigational Site 14429 | Bowling Green | Kentucky | 42101 | — |
| Teva Investigational Site 14147 | North Dartmouth | Massachusetts | 02747 | — |
| Teva Investigational Site 14157 | Quincy | Massachusetts | 02169 | — |
| Teva Investigational Site 14163 | Ann Arbor | Michigan | 48104 | — |
| Teva Investigational Site 14183 | Hazelwood | Missouri | 63042 | — |
| Teva Investigational Site 14170 | O'Fallon | Missouri | 63368 | — |
| Teva Investigational Site 14430 | Springfield | Missouri | 65810 | — |
| Teva Investigational Site 14165 | Las Vegas | Nevada | 89102 | — |
| Teva Investigational Site 14181 | Albuquerque | New Mexico | 87109 | — |
| Teva Investigational Site 14152 | Raleigh | North Carolina | 27609 | — |
| Teva Investigational Site 14185 | Raleigh | North Carolina | 27612 | — |
| Teva Investigational Site 14437 | Salisbury | North Carolina | 28144 | — |
| Teva Investigational Site 14167 | Winston-Salem | North Carolina | 27103 | — |
| Teva Investigational Site 14161 | Fargo | North Dakota | 58104 | — |
| Teva Investigational Site 14153 | Cincinnati | Ohio | 45219 | — |
| Teva Investigational Site 14432 | Dayton | Ohio | 45432 | — |
| Teva Investigational Site 14171 | Portland | Oregon | 97214 | — |
| Teva Investigational Site 14175 | Salem | Oregon | 97301 | — |
| Teva Investigational Site 14158 | Allentown | Pennsylvania | 18104 | — |
| Teva Investigational Site 14177 | Duncansville | Pennsylvania | 16635 | — |
| Teva Investigational Site 14156 | Warwick | Rhode Island | 02886 | — |
| Teva Investigational Site 14173 | Knoxville | Tennessee | 37938 | — |
| Teva Investigational Site 14150 | Memphis | Tennessee | 38119 | — |
| Teva Investigational Site 14151 | Memphis | Tennessee | 38119 | — |
| Teva Investigational Site 14178 | Memphis | Tennessee | 38119 | — |
| Teva Investigational Site 14184 | Austin | Texas | 78756 | — |
| Teva Investigational Site 14179 | Dallas | Texas | 75231 | — |
| Teva Investigational Site 14169 | Salt Lake City | Utah | 84102 | — |
| Teva Investigational Site 14146 | Charlottesville | Virginia | 22911 | — |
| Teva Investigational Site 14154 | Kenosha | Wisconsin | 53144 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03965091, 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 30, 2023 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03965091 live on ClinicalTrials.gov.