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Comparing Efficacy and Safety of 2 Dose Regimens of Subcutaneous Administration of TEV-48125 Versus Placebo for the Preventive Treatment of Chronic Migraine

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02621931
Recruitment Status : Completed
First Posted : December 4, 2015
Results First Posted : December 6, 2018
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )

Brief Summary:
The study is being conducted to evaluate two doses of TEV-48125 in adult patients with chronic migraine

Condition or disease Intervention/treatment Phase
Migraine Drug: Fremanezumab Drug: Placebo Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1130 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, Parallel-Group Study Comparing the Efficacy and Safety of 2 Dose Regimens of Subcutaneous Administration of Fremanezumab (TEV-48125) Versus Placebo for the Preventive Treatment of Chronic Migraine
Actual Study Start Date : March 22, 2016
Actual Primary Completion Date : April 11, 2017
Actual Study Completion Date : April 11, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
Placebo Comparator: Placebo
Matching Placebo
Drug: Placebo
Placebo 1.5 mL pre-filled syringes identical in appearance to active intervention. Study drug was administered at the clinical site.

Experimental: Fremanezumab 675 mg/placebo/placebo
Participants randomized to the fremanezumab 675 mg/placebo/placebo treatment arm received 675 mg of fremanezumab as 3 active injections (225 mg/1.5 mL) on Day 0, and placebo as a single 1.5-mL injection on Days 28 and 56.
Drug: Fremanezumab
Fremanezumab was provided as a sterile, unpreserved, aqueous solution for injection, 225 mg/1.5 mL pre-filled syringe for single-use administration. The 675 mg dose was given as 3 injections; doses of 225 mg were given as a single injection. Study drug was administered at the clinical site.
Other Name: TEV-48125, anti-calcitonin gene-related peptide (anti-CGRP)

Drug: Placebo
Placebo 1.5 mL pre-filled syringes identical in appearance to active intervention. Study drug was administered at the clinical site.

Experimental: Fremanezumab 675/225/225 mg
Participants randomized to the fremanezumab 675/225/225 mg treatment arm received 675 mg of fremanezumab as 3 active injections (225 mg/1.5 mL) on Day 0 and 225 mg of fremanezumab as 1 active injection (225 mg/1.5 mL) on Days 28 and 56.
Drug: Fremanezumab
Fremanezumab was provided as a sterile, unpreserved, aqueous solution for injection, 225 mg/1.5 mL pre-filled syringe for single-use administration. The 675 mg dose was given as 3 injections; doses of 225 mg were given as a single injection. Study drug was administered at the clinical site.
Other Name: TEV-48125, anti-calcitonin gene-related peptide (anti-CGRP)




Primary Outcome Measures :
  1. Change From Baseline in the Monthly Average Number of Headache Days of At Least Moderate Severity During the 12-Week Period After the First Dose of Study Drug [ Time Frame: Baseline (Days -28 to Day -1), Treatment (Days 1 - Week 12) ]
    Headaches were subjectively rated by participants as mild, moderate or severe. A headache day of at least moderate severity was defined as a calendar day (00:00 to 23:59) where the patient (using the electronic headache diary device) reports: - a day with headache pain that lasts ≥4 hours with a peak severity of at least moderate severity or - a day when the patient used acute migraine-specific medication (triptans or ergots) to treat a headache of any severity or duration. Monthly averages are derived and normalized to 28 days equivalent by the following formula: (# days of efficacy variable over relevant period / # days with assessments recorded in the e-diary over the relevant period) * 28. The change is calculated as post-baseline value - baseline value.

  2. Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Day 1 to Week 12 ]
    An adverse event (AE) was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents usual activities. Relationship of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.


Secondary Outcome Measures :
  1. Change From Baseline in the Monthly Average Number of Migraine Days During the 12-Week Period After the First Dose of Study Drug [ Time Frame: Baseline (Days -28 to Day -1), Treatment (Days 1 - Week 12) ]
    A migraine day was defined as when at least 1 of the following situations occurred: - a calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours of a headache endorsing criteria for migraine with or without aura - a calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours of a headache endorsing criteria for probable migraine, a migraine subtype where only 1 migraine criterion is missing - a calendar day (0:00 to 23:59) demonstrating a headache of any duration that was treated with migraine-specific medications (triptans and ergot compounds). Monthly averages are derived and normalized to 28 days equivalent by the following formula: (# days of efficacy variable over relevant period / # days with assessments recorded in the e-diary over the relevant period) * 28. The change is calculated as post-baseline value - baseline value.

  2. Percentage of Participants With At Least 50% Reduction In Monthly Average Number of Headache Days of At Least Moderate Severity [ Time Frame: Baseline (Days -28 to Day -1), Treatment: Month 1, Month 2, Month 3, Month 1-3 (Days 1 - Week 12) ]
    Responder rates were defined as the percentage of total subjects who reached at least a 50% reduction in the monthly average of headache days (as subjectively reported by participants in the study diary) of at least moderate severity relative to the baseline period. For the overall analysis (Month 1-3), patients who discontinued early were considered non-responders. Monthly averages are derived and normalized to 28 days equivalent by the following formula: (# days of efficacy variable over relevant period / # days with assessments recorded in the e-diary over the relevant period) * 28. The percentage reduction in monthly average is calculated as: ((baseline value - post-baseline value) / baseline value) * 100.

  3. Change From Baseline in the Monthly Average Number of Days of Use of Any Acute Headache Medicine During the 12 Week Period After the First Dose of Study Drug [ Time Frame: Baseline (Days -28 to Day -1), Treatment (Days 1 - Week 12) ]
    Participants recorded any migraine medications (name of drug, number of tablets/capsules, and the dose in milligrams per tablet/capsule) taken on each day in their electronic headache diary device. Acute migraine-specific medication included triptans or ergots. Monthly averages are derived and normalized to 28 days equivalent by the following formula: (# days of efficacy variable over relevant period / # days with assessments recorded in the e-diary over the relevant period) * 28. The change is calculated as post-baseline value - baseline value.

  4. Change From Baseline in the Number of Headache Days of At Least Moderate Severity During the 4 Week Period After the First Dose of Study Drug [ Time Frame: Baseline (Days -28 to Day -1), Treatment (Days 1 - Week 4) ]
    Headaches were subjectively rated by participants as mild, moderate or severe. A headache day of at least moderate severity was defined as a calendar day (00:00 to 23:59) where the patient (using the electronic headache diary device) reports: - a day with headache pain that lasts ≥4 hours with a peak severity of at least moderate severity or - a day when the patient used acute migraine-specific medication (triptans or ergots) to treat a headache of any severity or duration. The change is calculated as post-baseline value - baseline value.

  5. Change From Baseline in the Monthly Average Number of Headache Days of At Least Moderate Severity During the 12 Week Period After the First Dose of Study Medication in Patients Not Receiving Concomitant Preventive Migraine Medications [ Time Frame: Baseline (Days -28 to Day -1), Treatment (Days 1 - Week 12) ]
    A subset of patients (specified in the protocol not to exceed 30%) were allowed to use 1 concomitant migraine preventive medication. This outcome only includes those participants who did not take concomitant preventive migraine medication during this study. Headaches were subjectively rated by participants as mild, moderate or severe. A headache day of >= moderate severity was defined as a calendar day where the patient (using the electronic headache diary device) reports: - a day with headache pain that lasts ≥4 hours with a peak severity of >= moderate severity or - a day when the patient used acute migraine-specific medication (triptans or ergots) to treat a headache of any severity or duration. Monthly averages are derived and normalized to 28 days equivalent by the following formula: (# days of efficacy variable over relevant period / # days with assessments recorded in the e-diary over the relevant period) * 28. Change is post-baseline value - baseline value.

  6. Change From Baseline in Migraine-Related Disability Score, As Measured by the 6-Item Headache Impact Test (HIT) At Week 12 [ Time Frame: Baseline, 12 weeks ]
    The HIT-6 was developed by Kosinski et al (2003) as a short form for reliably assessing the adverse headache impact in clinical practice and clinical research settings. The questionnaire measures the adverse impact of headache on social functioning, role functioning, vitality, cognitive functioning, and psychological distress. It also assesses headache severity. Scores range from 36 to 78, where a higher score indicates a greater impact of headache on the daily life of the patient, i.e. scores ≤49 represent little or no impact, scores between 50 and 55 represent some impact, scores between 56 and 59 represent substantial impact; and scores ≥60 indicate severe impact. Negative change from baseline values indicate less adverse impact of headache.

  7. Electrocardiogram (ECG) Findings Shifts From Baseline to Overall [ Time Frame: Baseline (Day 0), Treatment Week 12 (or endpoint) ]
    12-lead ECGs were performed before other assessments (eg, blood draws and administration of questionnaires) and performed in triplicate. The worst post-baseline finding for the participant is summarized. Only participants with both baseline and post-baseline ECGs are included. The ECG was evaluated by the investigator at the time of recording (signed and dated), and the printout was kept in the source documentation file. When potentially clinically significant findings were detected by the investigator, a cardiologist at a central diagnostic center was consulted for a definitive interpretation. Any ECG finding that was judged by the investigator as a potentially clinically significant change (worsening) compared with a baseline value was considered an adverse event. - NCS = abnormal, not clinically significant. - CS= abnormal, clinically significant. Shift format is: baseline finding / worst post-baseline finding.

  8. Participants With Vital Signs Potentially Clinically Significant Abnormal Values [ Time Frame: Treatment Days 28, 56 and 84 (or endpoint). Changes from previous reading may reflect the baseline reading performed on Day 0. ]
    Vital signs were performed before other assessments (eg, blood draws and administration of questionnaires). Vital signs with potentially clinically significant abnormal findings included: - Pulse Rate High: >=120 and increase of >=15 beats per minute - Pulse Rate Low: <=50 and decrease of >=15 beats per minute - Systolic Blood Pressure Low: <=90 mmHg and decrease of >=20 mmHg - Diastolic Blood Pressure High: >=105 mmHg and increase of >=15 mmHg - Diastolic Blood Pressure Low: <=50 mmHg and decrease of >=15 mmHg - Respiratory Rate Low: <10 breaths / minute

  9. Participants With Serum Chemistry and Hematology Potentially Clinically Significant Abnormal Results [ Time Frame: Treatment Days 28, 56 and 84 (or endpoint) ]
    Serum chemistry and hematology laboratory tests with potentially clinically significant abnormal findings included: - Blood Urea Nitrogen (BUN) High: >=10.71 mmol/L - Creatinine High: >=177 umol/L - Bilirubin High: >=34.2 umol/L - Alanine Aminotransferase (ALT): >=3*upper limit of normal (ULN) - Aspartate Aminotransferase (AST): >=3*upper limit of normal (ULN) - Gamma Glutamyl Transferase (GGT): >=3*upper limit of normal (ULN) - Hemoglobin: Male: <115 g/L or Female: <=95 g/L - Hematocrit: Male: <0.37 L/L or Female: <0.32 L/L - Leukocytes: >=20*10^9/L or <=3*10^9/L - Eosinophils/Leukocytes: >=10% - Platelets: >=700*10^9/L or <=75*10^9/L

  10. Participants With Urinalysis Laboratory Tests Potentially Clinically Significant Abnormal Results [ Time Frame: Treatment Days 28, 56 and 84 (or endpoint). Changes from previous reading reflect the baseline reading performed on Day 0. ]
    Urinalysis with potentially clinically significant abnormal findings included: - Blood: >=2 unit increase from baseline - Urine Glucose (mg/dL): >=2 unit increase from baseline - Ketones (mg/dL): >=2 unit increase from baseline - Urine Protein (mg/dL): >=2 unit increase from baseline

  11. Prothrombin Time Shifts From Baseline to Endpoint [ Time Frame: Baseline (Day 0), Treatment Endpoint (Week 12) ]
    Shifts in prothrombin time from baseline to endpoint were summarized using patient counts grouped into three categories: - Low (below normal range) - Normal (within the normal range of 9.4 to 12.5 seconds) - High (above normal range) Shift format is: baseline finding / endpoint finding

  12. Injection Site Reaction Adverse Events [ Time Frame: Day 1 to Week 12 ]
    Counts of participants who reported treatment-emergent injection site reactions as AEs are summarized. Preferred terms from MedDRA version 18.1 are offered without a threshold applied.

  13. Participants With Positive Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) Results After the First Dose of Study Drug [ Time Frame: Baseline (Day 0), Treatment Days 28, 56, 84 ]

    The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) was used to assess the participant's suicidal ideation (severity and intensity) and behavior (Posner et al 2011). Suicidal behavior is defined as a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation is defined as a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation.

    The eC-SSRS Baseline/Screening version was completed by the participant at baseline, and the eC-SSRS Since Last Visit version was completed by the participant at all other time points. Any positive findings on the eC-SSRS Since Last Visit version required evaluation by a physician or doctoral-level psychologist. Findings after the first dose of study drug using the eC-SSRS Since Last Visit version are summarized.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males or females aged 18 to 70 years, inclusive, with migraine onset at ≤50 years of age
  • Patient signs and dates the informed consent document
  • Patient has history of migraine according to International Classification of Headache Disorders, or clinical judgment suggests a migraine diagnosis
  • 85% e-diary compliance
  • Total body weight between 99 and 250 lbs, inclusive

    • Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

  • Clinically significant hematological, cardiac, renal, endocrine, pulmonary, gastrointestinal, genitourinary, neurologic, hepatic, or ocular disease, at the discretion of the investigator
  • Evidence or medical history of clinically significant psychiatric issues, including any suicide attempt in the past, or suicidal ideation with a specific plan in the past 2 years
  • History of clinically significant cardiovascular disease or vascular ischemia (such as myocardial, neurological [eg, cerebral ischemia], peripheral extremity ischemia, or other ischemic event) or thromboembolic events (arterial or venous thrombotic or embolic events), such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism
  • Known infection or history of human immunodeficiency virus, tuberculosis, or chronic hepatitis B or C infection
  • Past or current history of cancer in the last 5 years, except for appropriately treated nonmelanoma skin carcinoma
  • Pregnant or nursing females
  • History of hypersensitivity reactions to injected proteins, including monoclonal antibodies
  • Participation in a clinical study of a new chemical entity or a prescription medicine within 2 months prior to study drug administration or 5 half-lives, whichever is longer

    • 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): NCT02621931


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Locations
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United States, Alabama
Teva Investigational Site 13628
Birmingham, Alabama, United States, 35211
Teva Investigational Site 13577
Birmingham, Alabama, United States, 35216
Teva Investigational Site 13577
Birmingham, Alabama, United States
Teva Investigational Site 13628
Birmingham, Alabama, United States
United States, Arizona
Teva Investigational Site 13606
Phoenix, Arizona, United States, 85018
Teva Investigational Site 13579
Phoenix, Arizona, United States, 85023
Teva Investigational Site 13579
Phoenix, Arizona, United States
Teva Investigational Site 13606
Phoenix, Arizona, United States
United States, Arkansas
Teva Investigational Site 13602
Little Rock, Arkansas, United States, 72205
Teva Investigational Site 13602
Little Rock, Arkansas, United States
United States, California
Teva Investigational Site 13568
Encino, California, United States, 91316
Teva Investigational Site 13568
Encino, California, United States
Teva Investigational Site 13546
Fullerton, California, United States, 92835
Teva Investigational Site 13546
Fullerton, California, United States
Teva Investigational Site 13540
Long Beach, California, United States, 90806
Teva Investigational Site 13540
Long Beach, California, United States
Teva Investigational Site 13632
Redlands, California, United States, 92374
Teva Investigational Site 13632
Redlands, California, United States
Teva Investigational Site 13571
Redondo Beach, California, United States, 90277
Teva Investigational Site 13571
Redondo Beach, California, United States
Teva Investigational Site 13573
San Diego, California, United States, 92103
Teva Investigational Site 13573
San Diego, California, United States
Teva Investigational Site 13538
Santa Monica, California, United States, 90404
Teva Investigational Site 13538
Santa Monica, California, United States
Teva Investigational Site 13594
Santa Rosa, California, United States, 95405
Teva Investigational Site 13594
Santa Rosa, California, United States
Teva Investigational Site 13595
Walnut Creek, California, United States, 94598
Teva Investigational Site 13595
Walnut Creek, California, United States
United States, Colorado
Teva Investigational Site 13629
Aurora, Colorado, United States, 80014
Teva Investigational Site 13629
Aurora, Colorado, United States
Teva Investigational Site 13557
Boulder, Colorado, United States, 80301
Teva Investigational Site 13557
Boulder, Colorado, United States
Teva Investigational Site 13593
Colorado Springs, Colorado, United States, 80918
Teva Investigational Site 13593
Colorado Springs, Colorado, United States
Teva Investigational Site 13633
Denver, Colorado, United States, 80210
Teva Investigational Site 13612
Denver, Colorado, United States, 80239
Teva Investigational Site 13612
Denver, Colorado, United States
Teva Investigational Site 13633
Denver, Colorado, United States
Teva Investigational Site 13631
Englewood, Colorado, United States, 80113
Teva Investigational Site 13631
Englewood, Colorado, United States
United States, Connecticut
Teva Investigational Site 13563
East Hartford, Connecticut, United States, 06118
Teva Investigational Site 13563
East Hartford, Connecticut, United States
Teva Investigational Site 13550
Stamford, Connecticut, United States, 06905
Teva Investigational Site 13550
Stamford, Connecticut, United States
United States, Florida
Teva Investigational Site 13635
Bradenton, Florida, United States, 34201
Teva Investigational Site 13635
Bradenton, Florida, United States
Teva Investigational Site 13597
Gainesville, Florida, United States, 32607
Teva Investigational Site 13597
Gainesville, Florida, United States
Teva Investigational Site 13607
Hialeah, Florida, United States, 33012
Teva Investigational Site 13607
Hialeah, Florida, United States
Teva Investigational Site 13559
Jacksonville, Florida, United States, 32205
Teva Investigational Site 13559
Jacksonville, Florida, United States
Teva Investigational Site 13584
Ocala, Florida, United States, 34471
Teva Investigational Site 13584
Ocala, Florida, United States
Teva Investigational Site 13587
Orlando, Florida, United States, 32806
Teva Investigational Site 13599
Orlando, Florida, United States, 32819
Teva Investigational Site 13551
Orlando, Florida, United States
Teva Investigational Site 13555
Orlando, Florida, United States
Teva Investigational Site 13587
Orlando, Florida, United States
Teva Investigational Site 13599
Orlando, Florida, United States
Teva Investigational Site 13567
Palm Beach Gardens, Florida, United States, 33410
Teva Investigational Site 13567
Palm Beach Gardens, Florida, United States
Teva Investigational Site 13553
Pembroke Pines, Florida, United States, 33026
Teva Investigational Site 13553
Pembroke Pines, Florida, United States
Teva Investigational Site 13616
Pinellas Park, Florida, United States, 33781
Teva Investigational Site 13616
Pinellas Park, Florida, United States
United States, Georgia
Teva Investigational Site 13620
Atlanta, Georgia, United States, 30312
Teva Investigational Site 13537
Atlanta, Georgia, United States, 30342
Teva Investigational Site 13537
Atlanta, Georgia, United States
Teva Investigational Site 13620
Atlanta, Georgia, United States
United States, Idaho
Teva Investigational Site 13604
Boise, Idaho, United States
Teva Investigational Site 13604
Meridian, Idaho, United States, 83642
United States, Illinois
Teva Investigational Site 13585
Chicago, Illinois, United States, 60607
Teva Investigational Site 13621
Chicago, Illinois, United States, 60654
Teva Investigational Site 13585
Chicago, Illinois, United States
Teva Investigational Site 13621
Chicago, Illinois, United States
Teva Investigational Site 13627
Evanston, Illinois, United States, 60201
Teva Investigational Site 13627
Evanston, Illinois, United States
United States, Indiana
Teva Investigational Site 13596
Indianapolis, Indiana, United States, 46254
Teva Investigational Site 13596
Indianapolis, Indiana, United States
United States, Kansas
Teva Investigational Site 13617
Wichita, Kansas, United States, 67207
Teva Investigational Site 13598
Wichita, Kansas, United States, 67211
Teva Investigational Site 13598
Wichita, Kansas, United States
Teva Investigational Site 13617
Wichita, Kansas, United States
United States, Kentucky
Teva Investigational Site 13566
Louisville, Kentucky, United States, 40207
Teva Investigational Site 13566
Louisville, Kentucky, United States
United States, Louisiana
Teva Investigational Site 13603
Metairie, Louisiana, United States, 70006
Teva Investigational Site 13603
Metairie, Louisiana, United States
United States, Maryland
Teva Investigational Site 13582
Baltimore, Maryland, United States
Teva Investigational Site 13582
Pikesville, Maryland, United States, 21208
United States, Massachusetts
Teva Investigational Site 13590
Boston, Massachusetts, United States, 02131
Teva Investigational Site 13590
Boston, Massachusetts, United States
Teva Investigational Site 13589
New Bedford, Massachusetts, United States, 02301
Teva Investigational Site 13589
New Bedford, Massachusetts, United States
Teva Investigational Site 13543
Watertown, Massachusetts, United States, 02472
Teva Investigational Site 13543
Watertown, Massachusetts, United States
United States, Michigan
Teva Investigational Site 13539
Ann Arbor, Michigan, United States, 48104
Teva Investigational Site 13539
Ann Arbor, Michigan, United States
United States, Minnesota
Teva Investigational Site 13542
Golden Valley, Minnesota, United States, 55422
Teva Investigational Site 13542
Golden Valley, Minnesota, United States
United States, Missouri
Teva Investigational Site 13534
Kansas City, Missouri, United States, 64114
Teva Investigational Site 13534
Kansas City, Missouri, United States
Teva Investigational Site 13619
Saint Louis, Missouri, United States, 63141
Teva Investigational Site 13619
Saint Louis, Missouri, United States
Teva Investigational Site 13536
Springfield, Missouri, United States
United States, Nebraska
Teva Investigational Site 13618
Fremont, Nebraska, United States, 68025
Teva Investigational Site 13618
Fremont, Nebraska, United States
United States, Nevada
Teva Investigational Site 13605
Las Vegas, Nevada, United States, 89106
Teva Investigational Site 13605
Las Vegas, Nevada, United States
United States, New Hampshire
Teva Investigational Site 13578
Lebanon, New Hampshire, United States, 03756
Teva Investigational Site 13578
Lebanon, New Hampshire, United States
United States, New Jersey
Teva Investigational Site 13575
Martinsville, New Jersey, United States
Teva Investigational Site 13575
Raritan, New Jersey, United States, 08869
United States, New Mexico
Teva Investigational Site 13588
Albuquerque, New Mexico, United States, 87102
Teva Investigational Site 13588
Albuquerque, New Mexico, United States
United States, New York
Teva Investigational Site 13576
Amherst, New York, United States, 14226
Teva Investigational Site 13576
Amherst, New York, United States
Teva Investigational Site 13565
Plainview, New York, United States, 11803
Teva Investigational Site 13565
Plainview, New York, United States
United States, North Carolina
Teva Investigational Site 13544
Greensboro, North Carolina, United States, 27401
Teva Investigational Site 13574
Greensboro, North Carolina, United States, 27408
Teva Investigational Site 13544
Greensboro, North Carolina, United States
Teva Investigational Site 13574
Greensboro, North Carolina, United States
Teva Investigational Site 13545
Raleigh, North Carolina, United States, 27607
Teva Investigational Site 13545
Raleigh, North Carolina, United States
United States, Ohio
Teva Investigational Site 13609
Akron, Ohio, United States, 44311
Teva Investigational Site 13634
Akron, Ohio, United States, 44311
Teva Investigational Site 13609
Akron, Ohio, United States
Teva Investigational Site 13634
Akron, Ohio, United States
Teva Investigational Site 13533
Cincinnati, Ohio, United States, 45227
Teva Investigational Site 13624
Cincinnati, Ohio, United States, 45249
Teva Investigational Site 13533
Cincinnati, Ohio, United States
Teva Investigational Site 13624
Cincinnati, Ohio, United States
Teva Investigational Site 13569
Cleveland, Ohio, United States, 44195
Teva Investigational Site 13569
Cleveland, Ohio, United States
Teva Investigational Site 13626
Columbus, Ohio, United States, 43212
Teva Investigational Site 13626
Columbus, Ohio, United States
Teva Investigational Site 13625
Mogadore, Ohio, United States, 44260
Teva Investigational Site 13625
Mogadore, Ohio, United States
United States, Oklahoma
Teva Investigational Site 13561
Oklahoma City, Oklahoma, United States, 73112
Teva Investigational Site 13561
Oklahoma City, Oklahoma, United States
United States, Oregon
Teva Investigational Site 13601
Eugene, Oregon, United States, 97401
Teva Investigational Site 13601
Eugene, Oregon, United States
United States, Pennsylvania
Teva Investigational Site 13591
Jenkintown, Pennsylvania, United States, 19046
Teva Investigational Site 13591
Jenkintown, Pennsylvania, United States
Teva Investigational Site 13554
Philadelphia, Pennsylvania, United States, 19107
Teva Investigational Site 13554
Philadelphia, Pennsylvania, United States
Teva Investigational Site 13608
Uniontown, Pennsylvania, United States, 15401
Teva Investigational Site 13608
Uniontown, Pennsylvania, United States
United States, South Carolina
Teva Investigational Site 13615
Greer, South Carolina, United States, 29650
Teva Investigational Site 13615
Greer, South Carolina, United States
Teva Investigational Site 13556
Mount Pleasant, South Carolina, United States, 29464
Teva Investigational Site 13556
Mount Pleasant, South Carolina, United States
United States, Tennessee
Teva Investigational Site 13560
Bristol, Tennessee, United States, 37620
Teva Investigational Site 13560
Bristol, Tennessee, United States
Teva Investigational Site 13532
Nashville, Tennessee, United States, 37203
Teva Investigational Site 13552
Nashville, Tennessee, United States, 37203
Teva Investigational Site 13532
Nashville, Tennessee, United States
Teva Investigational Site 13552
Nashville, Tennessee, United States
United States, Texas
Teva Investigational Site 13541
Austin, Texas, United States, 78731
Teva Investigational Site 13541
Austin, Texas, United States
Teva Investigational Site 13623
Dallas, Texas, United States, 75214
Teva Investigational Site 13623
Dallas, Texas, United States
Teva Investigational Site 13611
Plano, Texas, United States, 75024
Teva Investigational Site 13611
Plano, Texas, United States
Teva Investigational Site 13572
San Antonio, Texas, United States, 78229
Teva Investigational Site 13572
San Antonio, Texas, United States
United States, Utah
Teva Investigational Site 13614
Murray, Utah, United States, 84107
Teva Investigational Site 13614
Murray, Utah, United States
Teva Investigational Site 13581
West Jordan, Utah, United States, 84088
Teva Investigational Site 13581
West Jordan, Utah, United States
United States, Virginia
Teva Investigational Site 13630
Virginia Beach, Virginia, United States, 23454
Teva Investigational Site 13630
Virginia Beach, Virginia, United States
United States, Washington
Teva Investigational Site 13564
Seattle, Washington, United States, 98105
Teva Investigational Site 13586
Seattle, Washington, United States, 98105
Teva Investigational Site 13564
Seattle, Washington, United States
Teva Investigational Site 13586
Seattle, Washington, United States
United States, West Virginia
Teva Investigational Site 13600
Morgantown, West Virginia, United States, 26506
Teva Investigational Site 13600
Morgantown, West Virginia, United States
Canada, Ontario
Teva Investigational Site 11124
Hamilton, Ontario, Canada, L8N 1Y2
Teva Investigational Site 11124
Hamilton, Ontario, Canada
Canada
Teva Investigational Site 11120
Calgary, Canada, T3M 1M4
Teva Investigational Site 11120
Calgary, Canada
Teva Investigational Site 11121
Montreal, Canada, H2W 1V1
Teva Investigational Site 11121
Montreal, Canada
Teva Investigational Site 11122
Newmarket, Canada, L3Y5G8
Teva Investigational Site 11122
Newmarket, Canada
Teva Investigational Site 11123
Sarnia, Canada, N7T 4X3
Teva Investigational Site 11123
Sarnia, Canada
Czechia
Teva Investigational Site 54144
Brno, Czechia, 602 00
Teva Investigational Site 54144
Brno, Czechia
Teva Investigational Site 54141
Kunratice, Czechia, 14800
Teva Investigational Site 54141
Kunratice, Czechia
Teva Investigational Site 54145
Pardubice, Czechia, 53002
Teva Investigational Site 54145
Pardubice, Czechia
Teva Investigational Site 54142
Prague 4, Czechia, 140 59
Teva Investigational Site 54142
Prague 4, Czechia
Teva Investigational Site 54146
Praha 3, Czechia, 130 00
Teva Investigational Site 54146
Praha 3, Czechia
Teva Investigational Site 54143
Praha, Czechia, 100 00
Teva Investigational Site 54143
Praha, Czechia
Finland
Teva Investigational Site 40018
Helsinki, Finland, 00100
Teva Investigational Site 40017
Helsinki, Finland, 00930
Teva Investigational Site 40017
Helsinki, Finland
Teva Investigational Site 40018
Helsinki, Finland
Teva Investigational Site 40016
Turku, Finland, 20100
Teva Investigational Site 40016
Turku, Finland
Israel
Teva Investigational Site 80096
Holon, Israel, 58100
Teva Investigational Site 80096
Holon, Israel
Teva Investigational Site 80099
Jerusalem, Israel, 9112001
Teva Investigational Site 80099
Jerusalem, Israel
Teva Investigational Site 80098
Nahariya, Israel, 221001
Teva Investigational Site 80097
Netanya, Israel, 4244916
Teva Investigational Site 80097
Netanya, Israel
Teva Investigational Site 80100
Ramat Gan, Israel, 5262160
Teva Investigational Site 80100
Ramat Gan, Israel
Teva Investigational Site 80095
Tel Aviv, Israel, 64239
Japan
Teva Investigational Site 84072
Chofu-shi, Japan, 182-0006
Teva Investigational Site 84064
Chofu-shi, Japan
Teva Investigational Site 84072
Chofu-shi, Japan
Teva Investigational Site 84066
Kagoshima-shi, Japan
Teva Investigational Site 84066
Kagoshima, Japan, 892-0844
Teva Investigational Site 84069
Kai-shi, Japan
Teva Investigational Site 84069
Kai, Japan, 400-0124
Teva Investigational Site 84073
Kawasaki-shi, Japan
Teva Investigational Site 84073
Kawasaki, Japan, 211-8588
Teva Investigational Site 84067
Kyoto, Japan, 600-8811
Teva Investigational Site 84067
Kyoto, Japan
Teva Investigational Site 84062
Osaka-shi, Japan, 556-0015
Teva Investigational Site 84062
Osaka-shi, Japan
Teva Investigational Site 84070
Saitama-shi, Japan
Teva Investigational Site 84070
Saitama, Japan, 338-8577
Teva Investigational Site 84061
Sendai-shi, Japan, 982-0014
Teva Investigational Site 84061
Sendai-shi, Japan
Teva Investigational Site 84065
Shimotsuma, Japan
Teva Investigational Site 84068
Shizuoka-shi, Japan
Teva Investigational Site 84068
Shizuoka, Japan, 4200-853
Teva Investigational Site 84065
Tochigi, Japan, 321-0293
Teva Investigational Site 84064
Tokyo, Japan, 182-0006
Teva Investigational Site 84071
Toyonaka-shi, Japan
Teva Investigational Site 84071
Toyonaka, Japan
Poland
Teva Investigational Site 53364
Krakow, Poland, 31-523
Teva Investigational Site 53363
Krakow, Poland, 33-332
Teva Investigational Site 53363
Krakow, Poland
Teva Investigational Site 53364
Krakow, Poland
Teva Investigational Site 53366
Lublin, Poland, 20-022
Teva Investigational Site 53366
Lublin, Poland
Teva Investigational Site 53365
Poznan, Poland, 60-529
Teva Investigational Site 53365
Poznan, Poland
Teva Investigational Site 53367
Warsaw, Poland, 04-730
Teva Investigational Site 53367
Warsaw, Poland
Russian Federation
Teva Investigational Site 50399
Kazan, Russian Federation, 420012
Teva Investigational Site 50395
Kazan, Russian Federation, 420021
Teva Investigational Site 50395
Kazan, Russian Federation
Teva Investigational Site 50399
Kazan, Russian Federation
Teva Investigational Site 50394
Moscow, Russian Federation, 121467
Teva Investigational Site 50400
Moscow, Russian Federation, 129128
Teva Investigational Site 50394
Moscow, Russian Federation
Teva Investigational Site 50400
Moscow, Russian Federation
Teva Investigational Site 50398
Nizhniy Novgorod, Russian Federation, 603126
Teva Investigational Site 50396
Nizhniy Novgorod, Russian Federation, 603137
Teva Investigational Site 50396
Nizhniy Novgorod, Russian Federation
Teva Investigational Site 50398
Nizhniy Novgorod, Russian Federation
Teva Investigational Site 50397
Ufa, Russian Federation, 450007
Teva Investigational Site 50397
Ufa, Russian Federation
Spain
Teva Investigational Site 31207
Madrid, Spain, 28046
Teva Investigational Site 31207
Madrid, Spain
Teva Investigational Site 31208
Pamplona, Spain, 31008
Teva Investigational Site 31208
Pamplona, Spain
Teva Investigational Site 31205
Valladolid, Spain, 47003
Teva Investigational Site 31205
Valladolid, Spain
Teva Investigational Site 31206
Zaragoza, Spain, 50009
Teva Investigational Site 31206
Zaragoza, Spain
Sponsors and Collaborators
Teva Branded Pharmaceutical Products, R&D Inc.
Investigators
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Study Director: Teva Medical Expert, MD Teva Pharmaceuticals USA
  Study Documents (Full-Text)

Documents provided by Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. ):
Study Protocol  [PDF] March 30, 2016
Statistical Analysis Plan  [PDF] May 18, 2017


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Teva Branded Pharmaceutical Products, R&D Inc.
ClinicalTrials.gov Identifier: NCT02621931     History of Changes
Other Study ID Numbers: TV48125-CNS-30049
2015-004549-23 ( EudraCT Number )
First Posted: December 4, 2015    Key Record Dates
Results First Posted: December 6, 2018
Last Update Posted: December 6, 2018
Last Verified: November 2018

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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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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Antibodies, Monoclonal
Calcitonin Gene-Related Peptide
Calcitonin
Katacalcin
Immunologic Factors
Physiological Effects of Drugs
Vasodilator Agents
Calcium-Regulating Hormones and Agents
Bone Density Conservation Agents