A Study to Test the Effectiveness and Safety of Fremanezumab on Patients With Fibromyalgia

Study Purpose

The primary objective of the study is to estimate the treatment effect of fremanezumab administered subcutaneously in reducing pain in adult patients with 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 subcutaneously in adult patients with FM. The total duration of patient 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - approved for study participation by the Fibromyalgia Eligibility Review Committee.
  • - body mass index of 18.5 to 45 kg/m2 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 U/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 (Appendix G) with their partners during the entire study period and for 5 months after the last dose of the IMP.
  • - sexual abstinence is only considered a highly effective method if defined as refraining from heterosexual intercourse in the defined period.
  • - female patients 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 EOS Visit o Additional criteria apply, please contact the investigator for more information.

Exclusion Criteria:

  • - unable or unwilling to discontinue/washout of prohibited medications.
  • - ongoing pain that would confound or interfere with the assessment of the patient's FM pain or require excluded therapies during the patient'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 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03965091
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Teva Branded Pharmaceutical Products R&D, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Teva Medical Expert, MD
Principal Investigator Affiliation Teva Pharmaceuticals USA
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Fibromyalgia
Arms & Interventions

Arms

Experimental: Fremanezumab - Dose A

Experimental: Fremanezumab - Dose B

Placebo Comparator: Placebo

Interventions

Drug: - Fremanezumab - Dose A

Administered subcutaneously (sc) for 4 monthly doses at Visits 3, 4, 5, and 6.

Drug: - Fremanezumab - Dose B

Administered subcutaneously (sc) for 4 monthly doses at Visits 3, 4, 5, and 6.

Drug: - Placebo

Administered subcutaneously (sc) for 4 monthly doses at Visits 3, 4, 5, and 6.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Teva Investigational Site 14159, Birmingham, Alabama

Status

Recruiting

Address

Teva Investigational Site 14159

Birmingham, Alabama, 35216

Teva Investigational Site 14174, Huntsville, Alabama

Status

Completed

Address

Teva Investigational Site 14174

Huntsville, Alabama, 35801

Teva Investigational Site 14166, Oceanside, California

Status

Recruiting

Address

Teva Investigational Site 14166

Oceanside, California, 92056-4515

Teva Investigational Site 14168, Sacramento, California

Status

Recruiting

Address

Teva Investigational Site 14168

Sacramento, California, 95831

Teva Investigational Site 14164, San Diego, California

Status

Completed

Address

Teva Investigational Site 14164

San Diego, California, 92103

Teva Investigational Site 14172, Torrance, California

Status

Recruiting

Address

Teva Investigational Site 14172

Torrance, California, 90502

Teva Investigational Site 14178, Jacksonville, Florida

Status

Recruiting

Address

Teva Investigational Site 14178

Jacksonville, Florida, 32256

Teva Investigational Site 14149, Ocala, Florida

Status

Recruiting

Address

Teva Investigational Site 14149

Ocala, Florida, 34470

Teva Investigational Site 14180, Oldsmar, Florida

Status

Recruiting

Address

Teva Investigational Site 14180

Oldsmar, Florida, 34677

Teva Investigational Site 14151, Orlando, Florida

Status

Recruiting

Address

Teva Investigational Site 14151

Orlando, Florida, 32801

Teva Investigational Site 14162, Tampa, Florida

Status

Recruiting

Address

Teva Investigational Site 14162

Tampa, Florida, 33613-3923

Teva Investigational Site 14148, Chicago, Illinois

Status

Recruiting

Address

Teva Investigational Site 14148

Chicago, Illinois, 60634

Teva Investigational Site 14155, Evansville, Indiana

Status

Recruiting

Address

Teva Investigational Site 14155

Evansville, Indiana, 47714

Teva Investigational Site 14176, Overland Park, Kansas

Status

Recruiting

Address

Teva Investigational Site 14176

Overland Park, Kansas, 66210

Teva Investigational Site 14160, Wichita, Kansas

Status

Completed

Address

Teva Investigational Site 14160

Wichita, Kansas, 67205

Teva Investigational Site 14429, Bowling Green, Kentucky

Status

Recruiting

Address

Teva Investigational Site 14429

Bowling Green, Kentucky, 42101

Teva Investigational Site 14147, North Dartmouth, Massachusetts

Status

Recruiting

Address

Teva Investigational Site 14147

North Dartmouth, Massachusetts, 02747

Teva Investigational Site 14157, Quincy, Massachusetts

Status

Recruiting

Address

Teva Investigational Site 14157

Quincy, Massachusetts, 02169

Teva Investigational Site 14163, Ann Arbor, Michigan

Status

Recruiting

Address

Teva Investigational Site 14163

Ann Arbor, Michigan, 48104

Teva Investigational Site 14183, Hazelwood, Missouri

Status

Recruiting

Address

Teva Investigational Site 14183

Hazelwood, Missouri, 63042

Teva Investigational Site 14170, O'Fallon, Missouri

Status

Recruiting

Address

Teva Investigational Site 14170

O'Fallon, Missouri, 63368

Teva Investigational Site 14430, Springfield, Missouri

Status

Recruiting

Address

Teva Investigational Site 14430

Springfield, Missouri, 65810

Teva Investigational Site 14165, Las Vegas, Nevada

Status

Recruiting

Address

Teva Investigational Site 14165

Las Vegas, Nevada, 89102

Teva Investigational Site 14181, Albuquerque, New Mexico

Status

Recruiting

Address

Teva Investigational Site 14181

Albuquerque, New Mexico, 87109

Teva Investigational Site 14152, Raleigh, North Carolina

Status

Completed

Address

Teva Investigational Site 14152

Raleigh, North Carolina, 27609

Teva Investigational Site 14167, Winston-Salem, North Carolina

Status

Recruiting

Address

Teva Investigational Site 14167

Winston-Salem, North Carolina, 27103

Teva Investigational Site 14161, Fargo, North Dakota

Status

Recruiting

Address

Teva Investigational Site 14161

Fargo, North Dakota, 58104

Teva Investigational Site 14153, Cincinnati, Ohio

Status

Recruiting

Address

Teva Investigational Site 14153

Cincinnati, Ohio, 45219

Teva Investigational Site 14171, Portland, Oregon

Status

Recruiting

Address

Teva Investigational Site 14171

Portland, Oregon, 97214

Teva Investigational Site 14175, Salem, Oregon

Status

Recruiting

Address

Teva Investigational Site 14175

Salem, Oregon, 97301

Teva Investigational Site 14158, Allentown, Pennsylvania

Status

Recruiting

Address

Teva Investigational Site 14158

Allentown, Pennsylvania, 18104

Teva Investigational Site 14177, Duncansville, Pennsylvania

Status

Recruiting

Address

Teva Investigational Site 14177

Duncansville, Pennsylvania, 16635

Teva Investigational Site 14156, Warwick, Rhode Island

Status

Recruiting

Address

Teva Investigational Site 14156

Warwick, Rhode Island, 02886

Teva Investigational Site 14173, Knoxville, Tennessee

Status

Recruiting

Address

Teva Investigational Site 14173

Knoxville, Tennessee, 37938

Teva Investigational Site 14150, Memphis, Tennessee

Status

Recruiting

Address

Teva Investigational Site 14150

Memphis, Tennessee, 38119

Teva Investigational Site 14184, Austin, Texas

Status

Recruiting

Address

Teva Investigational Site 14184

Austin, Texas, 78756

Teva Investigational Site 14179, Dallas, Texas

Status

Recruiting

Address

Teva Investigational Site 14179

Dallas, Texas, 75231

Teva Investigational Site 14169, Salt Lake City, Utah

Status

Recruiting

Address

Teva Investigational Site 14169

Salt Lake City, Utah, 84102

Teva Investigational Site 14146, Charlottesville, Virginia

Status

Recruiting

Address

Teva Investigational Site 14146

Charlottesville, Virginia, 22911

Teva Investigational Site 14154, Kenosha, Wisconsin

Status

Completed

Address

Teva Investigational Site 14154

Kenosha, Wisconsin, 53144