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Trial record 34 of 164 for:    Recruiting, Not yet recruiting Studies | fibromyalgia

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03965091
Recruitment Status : Recruiting
First Posted : May 28, 2019
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products R&D, Inc. )

Brief Summary:

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 35 weeks, consisting of the screening period of up to 5 weeks, the double-blind treatment period of 16 weeks, and the 14-week follow-up period.


Condition or disease Intervention/treatment Phase
Fibromyalgia Drug: Fremanezumab - Dose A Drug: Fremanezumab - Dose B Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : May 31, 2019
Estimated Primary Completion Date : August 4, 2022
Estimated Study Completion Date : August 4, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Experimental: Fremanezumab - Dose A Drug: Fremanezumab - Dose A
Administered subcutaneously (sc) for 4 monthly doses at Visits 3, 4, 5, and 6.

Experimental: Fremanezumab - Dose B Drug: Fremanezumab - Dose B
Administered subcutaneously (sc) for 4 monthly doses at Visits 3, 4, 5, and 6.

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




Primary Outcome Measures :
  1. Change from baseline in the weekly average of the daily average (PI-NRS) score over the past 24 hours [ Time Frame: Baseline up to week 16 ]
    Pain Intensity-Numerical Rating Scale (PI-NRS) is an 11-point pain intensity numerical rating scale where 0=no pain and 10=worst possible pain.


Secondary Outcome Measures :
  1. change from baseline in the individual components of the Fibromyalgia Impact Questionnaire Revised (FIQR): symptom subscore, impact subscore, and functional subscore score [ Time Frame: Baseline up to week 16 ]
    The FIQR is a commonly used instrument in the evaluation of FM patients. It contains 21 questions in 3 domains: function (9 questions), overall impact (2 questions), and symptoms (10 questions). Questions are graded on a 0 to 10 numeric scale with 10 being the worst.

  2. responder rate of the Patient Global Impression of Change (PGIC) rating (percentage of patients much improved or very much improved) [ Time Frame: Baseline up to week 16 ]
    Scale evaluates all aspects of patients' health and assesses if there has been an improvement or decline in clinical status since the start of the study. Improvement is recorded on a 7-point scale, with 1 indicating very much improved and 7 indicating very much worse.

  3. percentage of patients who experience a ≥30% reduction in the weekly average of the daily average PI-NRS score [ Time Frame: Baseline up to week 16 ]
    An 11-point pain intensity numerical rating scale where 0=no pain and 10=worst possible pain.

  4. percentage of patients who experience a ≥50% reduction in the weekly average of the daily average PI-NRS score [ Time Frame: Baseline up to week 16 ]
    An 11-point pain intensity numerical rating scale where 0=no pain and 10=worst possible pain.

  5. change from baseline in the weekly average of the daily worst PI-NRS score over the past 24 hours [ Time Frame: Baseline up to week 16 ]
    An 11-point pain intensity numerical rating scale where 0=no pain and 10=worst possible pain.

  6. change from baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form (SF) 8a score [ Time Frame: Baseline up to week 16 ]
    Contains 8 items with a score range from 8 to 40. Each question has 5 response options ranging in value from 1 to 5 over the past 7 days. To find the total raw score for an SF with all questions answered, sum the values of the response to each question. For the adult 8-item form, the lowest possible raw score is 8; the highest possible raw score is 40, indicating worst sleep.

  7. change from baseline in the PROMIS Physical Function SF12a score [ Time Frame: Baseline up to week 16 ]
    Contains 12 items with a score ranging from 12 to 36. The PROMIS Physical Function Scale measures self-reported capability rather than actual performance of physical activities. This includes the functioning of one's upper extremities (dexterity), lower extremities (walking or mobility), and central regions (neck, back), as well as instrumental activities of daily living, such as running errands over the past over the past 7 days. A single Physical Function capability score is obtained from a SF. A lower score indicates more limited physical disability.

  8. change from baseline in the PROMIS Fatigue SF8a score [ Time Frame: Baseline up to week 16 ]
    Contains 8 items with a score range from 8 to 40. Each question has 5 response options ranging in value from 1 to 5 over the past 7 days. To find the total raw score for an SF with all questions answered, sum the values of the response to each question. For the adult 8-item form, the lowest possible raw score is 8; the highest possible raw score is 40, indicating worst sleep.

  9. number of adverse events [ Time Frame: Screening up to week 16 ]
  10. change from randomization in the clinical laboratory test: serum chemistry [ Time Frame: Baseline up to week 16 ]
  11. change from randomization in the clinical laboratory test: hematology [ Time Frame: Baseline up to week 16 ]
  12. change from randomization in the clinical laboratory test: urinalysis [ Time Frame: Baseline up to week 16 ]
  13. change from baseline in vital signs: pulse [ Time Frame: Baseline up to week 16 ]
  14. change from baseline in vital signs: respiratory rate [ Time Frame: Baseline up to week 16 ]
  15. change from baseline in vital signs: systolic blood pressure [ Time Frame: Baseline up to week 16 ]
  16. change from baseline in vital signs: diastolic blood pressure [ Time Frame: Baseline up to week 16 ]
  17. change from baseline in vital signs: oral body temperature [ Time Frame: Baseline up to week 16 ]
  18. clinically significant changes in physical examination including body weight [ Time Frame: Baseline up to week 16 ]
  19. abnormal standard 12-lead electrocardiogram (ECG) findings [ Time Frame: Baseline up to week 16 ]
  20. tolerability at the injection site [ Time Frame: Baseline up to week 16 ]
    including but not limited to pain, erythema, induration, and ecchymosis

  21. occurrence of hypersensitivity/anaphylaxis reactions using standardized criteria [ Time Frame: Baseline up to week 16 ]
    See APPENDIX C. CLINICAL CRITERIA FOR DIAGNOSING ANAPHYLAXIS

  22. suicidal ideation and behavior [ Time Frame: Baseline up to week 16 ]
    as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS). The C-SSRS is an assessment tool that evaluates suicidal ideation and behavior. Scale range: Yes or No response to 10 questions, with minimum to maximum range of 0 to 10. Lower score represents better outcomes.

  23. number (%) of patients who did not complete the study (Kaplan-Meier Survival Analysis) due to adverse events [ Time Frame: Baseline up to week 16 ]
  24. number (%) of patients who did not complete the study (Kaplan-Meier Survival Analysis) due to lack of efficacy [ Time Frame: Baseline up to week 16 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 o Additional criteria apply, please contact the investigator for more information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03965091


Contacts
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Contact: Teva U.S. Medical Information 1-888-483-8279 USMedInfo@tevapharm.com

Locations
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United States, Alabama
Teva Investigational Site 14159 Recruiting
Birmingham, Alabama, United States, 35216
Teva Investigational Site 14174 Completed
Huntsville, Alabama, United States, 35801
United States, California
Teva Investigational Site 14166 Recruiting
Oceanside, California, United States, 92056-4515
Teva Investigational Site 14168 Recruiting
Sacramento, California, United States, 95831
Teva Investigational Site 14164 Recruiting
San Diego, California, United States, 92103
Teva Investigational Site 14172 Recruiting
Torrance, California, United States, 90502
United States, Florida
Teva Investigational Site 14149 Recruiting
Ocala, Florida, United States, 34470
Teva Investigational Site 14151 Recruiting
Orlando, Florida, United States, 32801
Teva Investigational Site 14162 Recruiting
Tampa, Florida, United States, 33613-3923
United States, Illinois
Teva Investigational Site 14148 Recruiting
Chicago, Illinois, United States, 60634
United States, Indiana
Teva Investigational Site 14155 Recruiting
Evansville, Indiana, United States, 47714
United States, Kansas
Teva Investigational Site 14160 Recruiting
Wichita, Kansas, United States, 67205
United States, Massachusetts
Teva Investigational Site 14147 Recruiting
North Dartmouth, Massachusetts, United States, 02747
Teva Investigational Site 14157 Recruiting
Quincy, Massachusetts, United States, 02169
United States, Michigan
Teva Investigational Site 14163 Recruiting
Ann Arbor, Michigan, United States, 48104
United States, Missouri
Teva Investigational Site 14170 Recruiting
O'Fallon, Missouri, United States, 63368
United States, Nevada
Teva Investigational Site 14165 Recruiting
Las Vegas, Nevada, United States, 89102
United States, North Carolina
Teva Investigational Site 14152 Recruiting
Raleigh, North Carolina, United States, 27609
Teva Investigational Site 14167 Recruiting
Winston-Salem, North Carolina, United States, 27103
United States, North Dakota
Teva Investigational Site 14161 Recruiting
Fargo, North Dakota, United States, 58104
United States, Ohio
Teva Investigational Site 14153 Recruiting
Cincinnati, Ohio, United States, 45219
United States, Oregon
Teva Investigational Site 14171 Recruiting
Portland, Oregon, United States, 97214
Teva Investigational Site 14175 Recruiting
Salem, Oregon, United States, 97301
United States, Pennsylvania
Teva Investigational Site 14158 Recruiting
Allentown, Pennsylvania, United States, 18104
United States, Rhode Island
Teva Investigational Site 14156 Recruiting
Warwick, Rhode Island, United States, 02886
United States, Tennessee
Teva Investigational Site 14173 Recruiting
Knoxville, Tennessee, United States, 37938
Teva Investigational Site 14150 Recruiting
Memphis, Tennessee, United States, 38119
United States, Utah
Teva Investigational Site 14169 Recruiting
Salt Lake City, Utah, United States, 84102
United States, Virginia
Teva Investigational Site 14146 Recruiting
Charlottesville, Virginia, United States, 22911
United States, Wisconsin
Teva Investigational Site 14154 Recruiting
Kenosha, Wisconsin, United States, 53144
Sponsors and Collaborators
Teva Branded Pharmaceutical Products R&D, Inc.
Investigators
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Study Director: Teva Medical Expert, MD Teva Pharmaceuticals USA
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Responsible Party: Teva Branded Pharmaceutical Products R&D, Inc.
ClinicalTrials.gov Identifier: NCT03965091    
Other Study ID Numbers: TV48125-PN-20028
First Posted: May 28, 2019    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs