A Study to Test the Effectiveness and Safety of Fremanezumab on Participants With Fibromyalgia
NCT ID: NCT03965091
Last Updated: 2023-03-30
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
189 participants
INTERVENTIONAL
2019-07-31
2022-01-19
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Participants will receive placebo matching to fremanezumab SC on Days 1, 29, 57, and 85.
Placebo
Placebo matching to fremanezumab will be administered per schedule specified in the arm description.
Fremanezumab Dose A
Participants will receive fremanezumab SC on Days 1, 29, and 57 and placebo matched to fremanezumab SC on Day 85.
Fremanezumab
Fremanezumab will be administered per dose and schedule specified in the arm description.
Fremanezumab Dose B
Participants will receive fremanezumab SC on Days 1, 29, and 57 and placebo matched to fremanezumab SC on Day 85.
Fremanezumab
Fremanezumab will be administered per dose and schedule specified in the arm description.
Interventions
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Fremanezumab
Fremanezumab will be administered per dose and schedule specified in the arm description.
Placebo
Placebo matching to fremanezumab will be administered per schedule specified in the arm description.
Eligibility Criteria
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Inclusion Criteria
* body mass index of 18.5 to 45 kilograms (kg)/square meter (m\^2) and a body weight ≥45 kg
* agree to use only acetaminophen as rescue medication for FM-related pain (up to 1000 mg per dose and not to exceed 3000 mg/day for any indication throughout the study period)
* non-pharmacologic interventions (including normal daily exercise routines, chiropractic care, physical therapy, psychotherapy, and massage therapy) are unchanged for a minimum of 30 days prior to screening and will remain unchanged throughout the study
* agree to maintain a usual and unchanged physical exercise regimen
* must be of nonchildbearing potential or, defined as:
* women surgically sterile by documented complete hysterectomy, bilateral oophorectomy, or
* bitubal ligations or confirmed to be postmenopausal (at least 1 year since last menstrual period) and
* menopausal women confirmed by a follicle-stimulating hormone \>35 units (U)/liter (L)
* men surgically sterile by documented vasectomy OR
If of childbearing potential, patients must meet any of the following criteria:
* must use highly effective contraception method with their partners during the entire study period and for 5 months after the last dose of the study drug.
* sexual abstinence is only considered a highly effective method if defined as refraining from heterosexual intercourse in the defined period.
* female participants of childbearing potential must have a negative serum beta-human chorionic gonadotropin (β-HCG) pregnancy test at screening (confirmed by urine dipstick β-HCG pregnancy test at baseline).
* must agree not to participate in another interventional study from the screening period through the end of study (EOS) visit o Additional criteria apply, please contact the investigator for more information
Exclusion Criteria
* ongoing pain that would confound or interfere with the assessment of the participant's FM pain or require excluded therapies during the participant's participation in this study.
* surgery planned during the study period
* receiving prophylactic treatment for migraine-related disorders, including topiramate, valproic acid, onabotulinumtoxinA, amitriptyline, and nortriptyline
* known history of clinically significant or unstable hematologic, cardiac, or thromboembolic events
* known history of suicide attempt, suicidal behavior, or suicidal ideation within the last 12 months
* lifetime history of any psychotic and/or bipolar disorder
* current, untreated, moderate or severe major depressive disorder and/or anxiety
* known history of hypersensitivity reactions to injected proteins, including monoclonal antibodies (mAbs) and animal venoms, or a history of Stevens-Johnson Syndrome/toxic epidermal necrolysis syndrome o Additional criteria apply, please contact the investigator for more information
18 Years
75 Years
ALL
No
Sponsors
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Teva Branded Pharmaceutical Products R&D, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Teva Medical Expert, MD
Role: STUDY_DIRECTOR
Teva Branded Pharmaceutical Products R&D, Inc.
Locations
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Teva Investigational Site 14159
Birmingham, Alabama, United States
Teva Investigational Site 14174
Huntsville, Alabama, United States
Teva Investigational Site 14431
Mesa, Arizona, United States
Teva Investigational Site 14166
Oceanside, California, United States
Teva Investigational Site 14435
Panorama City, California, United States
Teva Investigational Site 14168
Sacramento, California, United States
Teva Investigational Site 14164
San Diego, California, United States
Teva Investigational Site 14172
Torrance, California, United States
Teva Investigational Site 14433
Stamford, Connecticut, United States
Teva Investigational Site 14149
Ocala, Florida, United States
Teva Investigational Site 14180
Oldsmar, Florida, United States
Teva Investigational Site 14182
Plantation, Florida, United States
Teva Investigational Site 14162
Tampa, Florida, United States
Teva Investigational Site 14434
Marietta, Georgia, United States
Teva Investigational Site 14148
Chicago, Illinois, United States
Teva Investigational Site 14436
Flossmoor, Illinois, United States
Teva Investigational Site 14155
Evansville, Indiana, United States
Teva Investigational Site 14176
Overland Park, Kansas, United States
Teva Investigational Site 14160
Wichita, Kansas, United States
Teva Investigational Site 14429
Bowling Green, Kentucky, United States
Teva Investigational Site 14147
North Dartmouth, Massachusetts, United States
Teva Investigational Site 14157
Quincy, Massachusetts, United States
Teva Investigational Site 14163
Ann Arbor, Michigan, United States
Teva Investigational Site 14183
Hazelwood, Missouri, United States
Teva Investigational Site 14170
O'Fallon, Missouri, United States
Teva Investigational Site 14430
Springfield, Missouri, United States
Teva Investigational Site 14165
Las Vegas, Nevada, United States
Teva Investigational Site 14181
Albuquerque, New Mexico, United States
Teva Investigational Site 14152
Raleigh, North Carolina, United States
Teva Investigational Site 14185
Raleigh, North Carolina, United States
Teva Investigational Site 14437
Salisbury, North Carolina, United States
Teva Investigational Site 14167
Winston-Salem, North Carolina, United States
Teva Investigational Site 14161
Fargo, North Dakota, United States
Teva Investigational Site 14153
Cincinnati, Ohio, United States
Teva Investigational Site 14432
Dayton, Ohio, United States
Teva Investigational Site 14171
Portland, Oregon, United States
Teva Investigational Site 14175
Salem, Oregon, United States
Teva Investigational Site 14158
Allentown, Pennsylvania, United States
Teva Investigational Site 14177
Duncansville, Pennsylvania, United States
Teva Investigational Site 14156
Warwick, Rhode Island, United States
Teva Investigational Site 14173
Knoxville, Tennessee, United States
Teva Investigational Site 14150
Memphis, Tennessee, United States
Teva Investigational Site 14151
Memphis, Tennessee, United States
Teva Investigational Site 14178
Memphis, Tennessee, United States
Teva Investigational Site 14184
Austin, Texas, United States
Teva Investigational Site 14179
Dallas, Texas, United States
Teva Investigational Site 14169
Salt Lake City, Utah, United States
Teva Investigational Site 14146
Charlottesville, Virginia, United States
Teva Investigational Site 14154
Kenosha, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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TV48125-PN-20028
Identifier Type: -
Identifier Source: org_study_id
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