Clinical trial NCT02629861: Efficacy and Safety of 2 Dose Regimens of TEV-48125 Versus Placebo for the Preventive Treatment of Episodic Migraine
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) vs Placebo for the Preventive Treatment of Episodic Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2015-12-14
Enrollment: 875
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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 265 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 or 5 half-lives, whichever is longer

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

Primary outcomes:
measure: Change From Baseline in the Monthly Average Number of Migraine Days During the 12-Week Period After the First Dose of Study Drug
timeFrame: Baseline (Days -28 to Day -1), Treatment (Days 1 - Week 12)
measure: Participants With Adverse Events
timeFrame: Day 1 to Week 12
Secondary outcomes:
measure: Percentage of Participants With At Least 50% Reduction In Monthly Average Number of Migraine Days During the 12-Week Period After the First Dose of Study Drug
timeFrame: Baseline (Days -28 to Day -1), Treatment Month 1, Month 2, Month 3, Month 1-3 (Days 1 - Week 12)
measure: 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
timeFrame: Baseline (Days -28 to Day -1), Treatment (Days 1 - Week 12)
measure: Change From Baseline in the Number of Migraine Days During the 4 Week Period After the First Dose of Study Drug
timeFrame: Baseline (Days -28 to Day -1), Treatment (Days 1 - Week 4)
measure: Change From Baseline in the Monthly Average Number of Migraine Days During the 12 Week Period After the First Dose of Study Medication in Patients Not Receiving Concomitant Preventive Migraine Medications
timeFrame: Baseline (Days -28 to Day -1), Treatment (Days 1 - Week 12)
measure: Change From Baseline in Migraine-Related Disability Score (MIDAS), As Measured by the Migraine Disability Assessment At 4 Weeks After the Last (3rd) Dose of Study Drug
timeFrame: Baseline (Day 0), Treatment Week 12 (4 weeks after the 3rd dose)
measure: Electrocardiogram Finding Shifts From Baseline to Overall
timeFrame: Baseline (Day 0), Treatment Week 12 (or early withdrawal)
measure: Participants With Vital Signs Potentially Clinically Significant Abnormal Values
timeFrame: Treatment Days 28, 56 and 84. Changes from previous reading may reflect the baseline reading performed on Day 0.
measure: Participants With Serum Chemistry and Hematology Potentially Clinically Significant Abnormal Results
timeFrame: Treatment Days 28, 56 and 84 (or early withdrawal)
measure: Participants With Urinalysis Laboratory Tests Potentially Clinically Significant Abnormal Results
timeFrame: Treatment Days 28, 56 and 84. Changes from previous reading reflect the baseline reading performed on Day 0.
measure: Prothrombin Time Shifts From Baseline to Endpoint
timeFrame: Baseline (Day 0), Treatment Endpoint (Week 12)
measure: Injection Site Reaction Adverse Events
timeFrame: Day 1 to Week 12
measure: Participants With Positive Electronic Columbia Suicide Severity Rating Scale Results After the First Dose of Study Drug
timeFrame: Day 1 to Week 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Teva Investigational Site 13628
state: Alabama
city: Birmingham
country: United States
facility: Teva Investigational Site 13577
state: Alabama
city: Birmingham
country: United States
facility: Teva Investigational Site 13577
state: Alabama
city: Birmingham
country: United States
facility: Teva Investigational Site 13628
state: Alabama
city: Phoenix
country: United States
facility: Teva Investigational Site 13606
state: Arizona
city: Phoenix
country: United States
facility: Teva Investigational Site 13579
state: Arizona
city: Phoenix
country: United States
facility: Teva Investigational Site 13579
state: Arizona
city: Phoenix
country: United States
facility: Teva Investigational Site 13606
state: Arizona
city: Little Rock
country: United States
facility: Teva Investigational Site 13602
state: Arkansas
city: Little Rock
country: United States
facility: Teva Investigational Site 13602
state: Arkansas
city: Encino
country: United States
facility: Teva Investigational Site 13568
state: California
city: Encino
country: United States
facility: Teva Investigational Site 13568
state: California
city: Fullerton
country: United States
facility: Teva Investigational Site 13546
state: California
city: Fullerton
country: United States
facility: Teva Investigational Site 13546
state: California
city: Long Beach
country: United States
facility: Teva Investigational Site 13540
state: California
city: Long Beach
country: United States
facility: Teva Investigational Site 13540
state: California
city: Redlands
country: United States
facility: Teva Investigational Site 13632
state: California
city: Redlands
country: United States
facility: Teva Investigational Site 13632
state: California
city: Redondo Beach
country: United States
facility: Teva Investigational Site 13571
state: California
city: Redondo Beach
country: United States
facility: Teva Investigational Site 13571
state: California
city: San Diego
country: United States
facility: Teva Investigational Site 13573
state: California
city: San Diego
country: United States
facility: Teva Investigational Site 13573
state: California
city: Santa Monica
country: United States
facility: Teva Investigational Site 13538
state: California
city: Santa Monica
country: United States
facility: Teva Investigational Site 13538
state: California
city: Santa Rosa
country: United States
facility: Teva Investigational Site 13594
state: California
city: Santa Rosa
country: United States
facility: Teva Investigational Site 13594
state: California
city: Walnut Creek
country: United States
facility: Teva Investigational Site 13595
state: California
city: Walnut Creek
country: United States
facility: Teva Investigational Site 13595
state: California
city: Aurora
country: United States
facility: Teva Investigational Site 13629
state: Colorado
city: Aurora
country: United States
facility: Teva Investigational Site 13629
state: Colorado
city: Boulder
country: United States
facility: Teva Investigational Site 13557
state: Colorado
city: Boulder
country: United States
facility: Teva Investigational Site 13557
state: Colorado
city: Colorado Springs
country: United States
facility: Teva Investigational Site 13593
state: Colorado
city: Colorado Springs
country: United States
facility: Teva Investigational Site 13593
state: Colorado
city: Denver
country: United States
facility: Teva Investigational Site 13633
state: Colorado
city: Denver
country: United States
facility: Teva Investigational Site 13612
state: Colorado
city: Denver
country: United States
facility: Teva Investigational Site 13612
state: Colorado
city: Denver
country: United States
facility: Teva Investigational Site 13633
state: Colorado
city: Englewood
country: United States
facility: Teva Investigational Site 13631
state: Colorado
city: Englewood
country: United States
facility: Teva Investigational Site 13631
state: Colorado
city: East Hartford
country: United States
facility: Teva Investigational Site 13563
state: Connecticut
city: East Hartford
country: United States
facility: Teva Investigational Site 13563
state: Connecticut
city: Stamford
country: United States
facility: Teva Investigational Site 13550
state: Connecticut
city: Stamford
country: United States
facility: Teva Investigational Site 13550
state: Connecticut
city: Bradenton
country: United States
facility: Teva Investigational Site 13635
state: Florida
city: Bradenton
country: United States
facility: Teva Investigational Site 13635
state: Florida
city: Gainesville
country: United States
facility: Teva Investigational Site 13597
state: Florida
city: Gainesville
country: United States
facility: Teva Investigational Site 13597
state: Florida
city: Hialeah
country: United States
facility: Teva Investigational Site 13607
state: Florida
city: Hialeah
country: United States
facility: Teva Investigational Site 13607
state: Florida
city: Jacksonville
country: United States
facility: Teva Investigational Site 13559
state: Florida
city: Jacksonville
country: United States
facility: Teva Investigational Site 13559
state: Florida
city: Ocala
country: United States
facility: Teva Investigational Site 13584
state: Florida
city: Ocala
country: United States
facility: Teva Investigational Site 13584
state: Florida
city: Orlando
country: United States
facility: Teva Investigational Site 13587
state: Florida
city: Orlando
country: United States
facility: Teva Investigational Site 13551
state: Florida
city: Orlando
country: United States
facility: Teva Investigational Site 13555
state: Florida
city: Orlando
country: United States
facility: Teva Investigational Site 13587
state: Florida
city: Orlando
country: United States
facility: Teva Investigational Site 13599
state: Florida
city: Pembroke Pines
country: United States
facility: Teva Investigational Site 13553
state: Florida
city: Pembroke Pines
country: United States
facility: Teva Investigational Site 13553
state: Florida
city: Pinellas Park
country: United States
facility: Teva Investigational Site 13616
state: Florida
city: Pinellas Park
country: United States
facility: Teva Investigational Site 13616
state: Florida
city: West Palm Beach
country: United States
facility: Teva Investigational Site 13567
state: Florida
city: West Palm Beach
country: United States
facility: Teva Investigational Site 13567
state: Florida
city: Atlanta
country: United States
facility: Teva Investigational Site 13620
state: Georgia
city: Atlanta
country: United States
facility: Teva Investigational Site 13537
state: Georgia
city: Atlanta
country: United States
facility: Teva Investigational Site 13537
state: Georgia
city: Atlanta
country: United States
facility: Teva Investigational Site 13620
state: Georgia
city: Boise
country: United States
facility: Teva Investigational Site 13604
state: Idaho
city: Meridian
country: United States
facility: Teva Investigational Site 13604
state: Idaho
city: Chicago
country: United States
facility: Teva Investigational Site 13585
state: Illinois
city: Chicago
country: United States
facility: Teva Investigational Site 13621
state: Illinois
city: Chicago
country: United States
facility: Teva Investigational Site 13585
state: Illinois
city: Chicago
country: United States
facility: Teva Investigational Site 13621
state: Illinois
city: Evanston
country: United States
facility: Teva Investigational Site 13627
state: Illinois
city: Evanston
country: United States
facility: Teva Investigational Site 13627
state: Illinois
city: Indianapolis
country: United States
facility: Teva Investigational Site 13596
state: Indiana
city: Indianapolis
country: United States
facility: Teva Investigational Site 13596
state: Indiana
city: Wichita
country: United States
facility: Teva Investigational Site 13617
state: Kansas
city: Wichita
country: United States
facility: Teva Investigational Site 13598
state: Kansas
city: Wichita
country: United States
facility: Teva Investigational Site 13598
state: Kansas
city: Wichita
country: United States
facility: Teva Investigational Site 13617
state: Kansas
city: Louisville
country: United States
facility: Teva Investigational Site 13566
state: Kentucky
city: Louisville
country: United States
facility: Teva Investigational Site 13566
state: Kentucky
city: Metairie
country: United States
facility: Teva Investigational Site 13603
state: Louisiana
city: Metairie
country: United States
facility: Teva Investigational Site 13603
state: Louisiana
city: Baltimore
country: United States
facility: Teva Investigational Site 13582
state: Maryland
city: Pikesville
country: United States
facility: Teva Investigational Site 13582
state: Maryland
city: Boston
country: United States
facility: Teva Investigational Site 13590
state: Massachusetts
city: Boston
country: United States
facility: Teva Investigational Site 13590
state: Massachusetts
city: New Bedford
country: United States
facility: Teva Investigational Site 13589
state: Massachusetts
city: New Bedford
country: United States
facility: Teva Investigational Site 13589
state: Massachusetts
city: Wellesley Hills
country: United States
facility: Teva Investigational Site 13543
state: Massachusetts
city: Wellesley Hills
country: United States
facility: Teva Investigational Site 13543
state: Massachusetts
city: Ann Arbor
country: United States
facility: Teva Investigational Site 13539
state: Michigan
city: Ann Arbor
country: United States
facility: Teva Investigational Site 13539
state: Michigan
city: Golden Valley
country: United States
facility: Teva Investigational Site 13542
state: Minnesota
city: Golden Valley
country: United States
facility: Teva Investigational Site 13542
state: Minnesota
city: Kansas City
country: United States
facility: Teva Investigational Site 13534
state: Missouri
city: Kansas City
country: United States
facility: Teva Investigational Site 13534
state: Missouri
city: Saint Louis
country: United States
facility: Teva Investigational Site 13619
state: Missouri
city: Saint Louis
country: United States
facility: Teva Investigational Site 13619
state: Missouri
city: Springfield
country: United States
facility: Teva Investigational Site 13536
state: Missouri
city: Fremont
country: United States
facility: Teva Investigational Site 13618
state: Nebraska
city: Fremont
country: United States
facility: Teva Investigational Site 13618
state: Nebraska
city: Las Vegas
country: United States
facility: Teva Investigational Site 13605
state: Nevada
city: Las Vegas
country: United States
facility: Teva Investigational Site 13605
state: Nevada
city: Lebanon
country: United States
facility: Teva Investigational Site 13578
state: New Hampshire
city: Lebanon
country: United States
facility: Teva Investigational Site 13578
state: New Hampshire
city: Martinsville
country: United States
facility: Teva Investigational Site 13575
state: New Jersey
city: Raritan
country: United States
facility: Teva Investigational Site 13575
state: New Jersey
city: Albuquerque
country: United States
facility: Teva Investigational Site 13588
state: New Mexico
city: Albuquerque
country: United States
facility: Teva Investigational Site 13588
state: New Mexico
city: Amherst
country: United States
facility: Teva Investigational Site 13576
state: New York
city: Amherst
country: United States
facility: Teva Investigational Site 13576
state: New York
city: Plainview
country: United States
facility: Teva Investigational Site 13565
state: New York
city: Plainview
country: United States
facility: Teva Investigational Site 13565
state: New York
city: Greensboro
country: United States
facility: Teva Investigational Site 13544
state: North Carolina
city: Greensboro
country: United States
facility: Teva Investigational Site 13574
state: North Carolina
city: Greensboro
country: United States
facility: Teva Investigational Site 13544
state: North Carolina
city: Greensboro
country: United States
facility: Teva Investigational Site 13574
state: North Carolina
city: Raleigh
country: United States
facility: Teva Investigational Site 13545
state: North Carolina
city: Raleigh
country: United States
facility: Teva Investigational Site 13545
state: North Carolina
city: Akron
country: United States
facility: Teva Investigational Site 13609
state: Ohio
city: Akron
country: United States
facility: Teva Investigational Site 13634
state: Ohio
city: Akron
country: United States
facility: Teva Investigational Site 13609
state: Ohio
city: Akron
country: United States
facility: Teva Investigational Site 13634
state: Ohio
city: Cincinnati
country: United States
facility: Teva Investigational Site 13533
state: Ohio
city: Cincinnati
country: United States
facility: Teva Investigational Site 13624
state: Ohio
city: Cincinnati
country: United States
facility: Teva Investigational Site 13533
state: Ohio
city: Cincinnati
country: United States
facility: Teva Investigational Site 13624
state: Ohio
city: Cleveland
country: United States
facility: Teva Investigational Site 13569
state: Ohio
city: Cleveland
country: United States
facility: Teva Investigational Site 13569
state: Ohio
city: Columbus
country: United States
facility: Teva Investigational Site 13626
state: Ohio
city: Columbus
country: United States
facility: Teva Investigational Site 13626
state: Ohio
city: Mogadore
country: United States
facility: Teva Investigational Site 13625
state: Ohio
city: Mogadore
country: United States
facility: Teva Investigational Site 13625
state: Ohio
city: Oklahoma City
country: United States
facility: Teva Investigational Site 13561
state: Oklahoma
city: Oklahoma City
country: United States
facility: Teva Investigational Site 13561
state: Oklahoma
city: Eugene
country: United States
facility: Teva Investigational Site 13601
state: Oregon
city: Eugene
country: United States
facility: Teva Investigational Site 13601
state: Oregon
city: Jenkintown
country: United States
facility: Teva Investigational Site 13591
state: Pennsylvania
city: Jenkintown
country: United States
facility: Teva Investigational Site 13591
state: Pennsylvania
city: Philadelphia
country: United States
facility: Teva Investigational Site 13554
state: Pennsylvania
city: Philadelphia
country: United States
facility: Teva Investigational Site 13554
state: Pennsylvania
city: Uniontown
country: United States
facility: Teva Investigational Site 13608
state: Pennsylvania
city: Uniontown
country: United States
facility: Teva Investigational Site 13608
state: Pennsylvania
city: Greer
country: United States
facility: Teva Investigational Site 13615
state: South Carolina
city: Greer
country: United States
facility: Teva Investigational Site 13615
state: South Carolina
city: Mount Pleasant
country: United States
facility: Teva Investigational Site 13556
state: South Carolina
city: Mount Pleasant
country: United States
facility: Teva Investigational Site 13556
state: South Carolina
city: Bristol
country: United States
facility: Teva Investigational Site 13560
state: Tennessee
city: Bristol
country: United States
facility: Teva Investigational Site 13560
state: Tennessee
city: Nashville
country: United States
facility: Teva Investigational Site 13532
state: Tennessee
city: Nashville
country: United States
facility: Teva Investigational Site 13552
state: Tennessee
city: Nashville
country: United States
facility: Teva Investigational Site 13532
state: Tennessee
city: Nashville
country: United States
facility: Teva Investigational Site 13552
state: Tennessee
city: Austin
country: United States
facility: Teva Investigational Site 13541
state: Texas
city: Austin
country: United States
facility: Teva Investigational Site 13541
state: Texas
city: Dallas
country: United States
facility: Teva Investigational Site 13623
state: Texas
city: Dallas
country: United States
facility: Teva Investigational Site 13623
state: Texas
city: Plano
country: United States
facility: Teva Investigational Site 13611
state: Texas
city: Plano
country: United States
facility: Teva Investigational Site 13611
state: Texas
city: San Antonio
country: United States
facility: Teva Investigational Site 13572
state: Texas
city: San Antonio
country: United States
facility: Teva Investigational Site 13572
state: Texas
city: Murray
country: United States
facility: Teva Investigational Site 13614
state: Utah
city: Murray
country: United States
facility: Teva Investigational Site 13614
state: Utah
city: West Jordan
country: United States
facility: Teva Investigational Site 13581
state: Utah
city: West Jordan
country: United States
facility: Teva Investigational Site 13581
state: Utah
city: Virginia Beach
country: United States
facility: Teva Investigational Site 13630
state: Virginia
city: Virginia Beach
country: United States
facility: Teva Investigational Site 13630
state: Virginia
city: Seattle
country: United States
facility: Teva Investigational Site 13564
state: Washington
city: Seattle
country: United States
facility: Teva Investigational Site 13586
state: Washington
city: Seattle
country: United States
facility: Teva Investigational Site 13564
state: Washington
city: Seattle
country: United States
facility: Teva Investigational Site 13586
state: Washington
city: Morgantown
country: United States
facility: Teva Investigational Site 13600
state: West Virginia
city: Morgantown
country: United States
facility: Teva Investigational Site 13600
state: West Virginia
city: Hamilton
country: Canada
facility: Teva Investigational Site 11124
state: Ontario
city: Hamilton
country: Canada
facility: Teva Investigational Site 11124
state: Ontario
city: Calgary
country: Canada
facility: Teva Investigational Site 11120
city: Calgary
country: Canada
facility: Teva Investigational Site 11120
city: Montreal
country: Canada
facility: Teva Investigational Site 11121
city: Montreal
country: Canada
facility: Teva Investigational Site 11121
city: Newmarket
country: Canada
facility: Teva Investigational Site 11122
city: Newmarket
country: Canada
facility: Teva Investigational Site 11122
city: Sarnia
country: Canada
facility: Teva Investigational Site 11123
city: Sarnia
country: Canada
facility: Teva Investigational Site 11123
city: Brno
country: Czechia
facility: Teva Investigational Site 54144
city: Brno
country: Czechia
facility: Teva Investigational Site 54144
city: Kunratice
country: Czechia
facility: Teva Investigational Site 54141
city: Kunratice
country: Czechia
facility: Teva Investigational Site 54141
city: Pardubice
country: Czechia
facility: Teva Investigational Site 54145
city: Pardubice
country: Czechia
facility: Teva Investigational Site 54145
city: Prague 4
country: Czechia
facility: Teva Investigational Site 54142
city: Prague-4-Krc
country: Czechia
facility: Teva Investigational Site 54142
city: Praha 3
country: Czechia
facility: Teva Investigational Site 54146
city: Praha 3
country: Czechia
facility: Teva Investigational Site 54146
city: Praha
country: Czechia
facility: Teva Investigational Site 54143
city: Praha
country: Czechia
facility: Teva Investigational Site 54143
city: Helsinki
country: Finland
facility: Teva Investigational Site 40018
city: Helsinki
country: Finland
facility: Teva Investigational Site 40017
city: Helsinki
country: Finland
facility: Teva Investigational Site 40017
city: Helsinki
country: Finland
facility: Teva Investigational Site 40018
city: Turku
country: Finland
facility: Teva Investigational Site 40016
city: Turku
country: Finland
facility: Teva Investigational Site 40016
city: Holon
country: Israel
facility: Teva Investigational Site 80096
city: Holon
country: Israel
facility: Teva Investigational Site 80096
city: Jerusalem
country: Israel
facility: Teva Investigational Site 80099
city: Jerusalem
country: Israel
facility: Teva Investigational Site 80099
city: Nahariya
country: Israel
facility: Teva Investigational Site 80098
city: Nahariya
country: Israel
facility: Teva Investigational Site 80098
city: Netanya
country: Israel
facility: Teva Investigational Site 80097
city: Netanya
country: Israel
facility: Teva Investigational Site 80097
city: Ramat Gan
country: Israel
facility: Teva Investigational Site 80100
city: Ramat Gan
country: Israel
facility: Teva Investigational Site 80100
city: Tel Aviv
country: Israel
facility: Teva Investigational Site 80095
city: Tel Aviv
country: Israel
facility: Teva Investigational Site 80095
city: Chofu-shi
country: Japan
facility: Teva Investigational Site 84072
city: Chofu-shi
country: Japan
facility: Teva Investigational Site 84064
city: Chofu-shi
country: Japan
facility: Teva Investigational Site 84072
city: Kagoshima-shi
country: Japan
facility: Teva Investigational Site 84066
city: Kagoshima
country: Japan
facility: Teva Investigational Site 84066
city: Kai-shi
country: Japan
facility: Teva Investigational Site 84069
city: Kai
country: Japan
facility: Teva Investigational Site 84069
city: Kawasaki-shi
country: Japan
facility: Teva Investigational Site 84073
city: Kawasaki
country: Japan
facility: Teva Investigational Site 84073
city: Kyoto
country: Japan
facility: Teva Investigational Site 84067
city: Kyoto
country: Japan
facility: Teva Investigational Site 84067
city: Osaka-shi
country: Japan
facility: Teva Investigational Site 84062
city: Osaka-shi
country: Japan
facility: Teva Investigational Site 84062
city: Saitama-shi
country: Japan
facility: Teva Investigational Site 84070
city: Saitama
country: Japan
facility: Teva Investigational Site 84070
city: Sendai-shi
country: Japan
facility: Teva Investigational Site 84061
city: Sendai-shi
country: Japan
facility: Teva Investigational Site 84061
city: Shimotsuma
country: Japan
facility: Teva Investigational Site 84065
city: Shinjuku-ku
country: Japan
facility: Teva Investigational Site 84063
city: Shizuoka-shi
country: Japan
facility: Teva Investigational Site 84068
city: Shizuoka
country: Japan
facility: Teva Investigational Site 84068
city: Tochigi
country: Japan
facility: Teva Investigational Site 84065
city: Tokyo
country: Japan
facility: Teva Investigational Site 84064
city: Toyonaka-shi
country: Japan
facility: Teva Investigational Site 84071
city: Toyonaka
country: Japan
facility: Teva Investigational Site 84071
city: Krakow
country: Poland
facility: Teva Investigational Site 53364
city: Krakow
country: Poland
facility: Teva Investigational Site 53363
city: Krakow
country: Poland
facility: Teva Investigational Site 53363
city: Krakow
country: Poland
facility: Teva Investigational Site 53364
city: Lublin
country: Poland
facility: Teva Investigational Site 53366
city: Lublin
country: Poland
facility: Teva Investigational Site 53366
city: Poznan
country: Poland
facility: Teva Investigational Site 53365
city: Poznan
country: Poland
facility: Teva Investigational Site 53365
city: Warsaw
country: Poland
facility: Teva Investigational Site 53367
city: Warsaw
country: Poland
facility: Teva Investigational Site 53367
city: Kazan
country: Russian Federation
facility: Teva Investigational Site 50399
city: Kazan
country: Russian Federation
facility: Teva Investigational Site 50395
city: Kazan
country: Russian Federation
facility: Teva Investigational Site 50395
city: Kazan
country: Russian Federation
facility: Teva Investigational Site 50399
city: Moscow
country: Russian Federation
facility: Teva Investigational Site 50394
city: Moscow
country: Russian Federation
facility: Teva Investigational Site 50400
city: Moscow
country: Russian Federation
facility: Teva Investigational Site 50394
city: Moscow
country: Russian Federation
facility: Teva Investigational Site 50400
city: Nizhniy Novgorod
country: Russian Federation
facility: Teva Investigational Site 50398
city: Nizhniy Novgorod
country: Russian Federation
facility: Teva Investigational Site 50396
city: Nizhniy Novgorod
country: Russian Federation
facility: Teva Investigational Site 50396
city: Nizhniy Novgorod
country: Russian Federation
facility: Teva Investigational Site 50398
city: Ufa
country: Russian Federation
facility: Teva Investigational Site 50397
city: Ufa
country: Russian Federation
facility: Teva Investigational Site 50397
city: Madrid
country: Spain
facility: Teva Investigational Site 31207
city: Madrid
country: Spain
facility: Teva Investigational Site 31207
city: Pamplona
country: Spain
facility: Teva Investigational Site 31208
city: Pamplona
country: Spain
facility: Teva Investigational Site 31208
city: Valladolid
country: Spain
facility: Teva Investigational Site 31205
city: Valladolid
country: Spain
facility: Teva Investigational Site 31205
city: Zaragoza
country: Spain
facility: Teva Investigational Site 31206
city: Zaragoza
country: Spain
facility: Teva Investigational Site 31206
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Teva Medical Expert, MD
role: STUDY_DIRECTOR
References:
citation: McAllister P, Cohen JM, Campos VR, Ning X, Janka L, Barash S. Impact of fremanezumab on disability outcomes in patients with episodic and chronic migraine: a pooled analysis of phase 3 studies. J Headache Pain. 2022 Aug 29;23(1):112. doi: 10.1186/s10194-022-01438-4.
citation: Diener HC, McAllister P, Jurgens TP, Kessler Y, Ning X, Cohen JM, Campos VR, Barash S, Silberstein SD. Safety and tolerability of fremanezumab in patients with episodic and chronic migraine: a pooled analysis of phase 3 studies. Cephalalgia. 2022 Jul;42(8):769-780. doi: 10.1177/03331024221076485. Epub 2022 Mar 25.
citation: Nahas SJ, Naegel S, Cohen JM, Ning X, Janka L, Campos VR, Krasenbaum LJ, Holle-Lee D, Kudrow D, Lampl C. Efficacy and safety of fremanezumab in clinical trial participants aged >/=60 years with episodic or chronic migraine: pooled results from 3 randomized, double-blind, placebo-controlled phase 3 studies. J Headache Pain. 2021 Nov 24;22(1):141. doi: 10.1186/s10194-021-01351-2.
citation: Silberstein SD, Cohen JM, Yang R, Gandhi SK, Du E, Jann AE, Marmura MJ. Treatment benefit among migraine patients taking fremanezumab: results from a post hoc responder analysis of two placebo-controlled trials. J Headache Pain. 2021 Jan 7;22(1):2. doi: 10.1186/s10194-020-01212-4.
citation: Brandes JL, Kudrow D, Yeung PP, Sakai F, Aycardi E, Blankenbiller T, Grozinski-Wolff M, Yang R, Ma Y. Effects of fremanezumab on the use of acute headache medication and associated symptoms of migraine in patients with episodic migraine. Cephalalgia. 2020 Apr;40(5):470-477. doi: 10.1177/0333102419885905. Epub 2019 Nov 21.
citation: Dodick DW, Silberstein SD, Bigal ME, Yeung PP, Goadsby PJ, Blankenbiller T, Grozinski-Wolff M, Yang R, Ma Y, Aycardi E. Effect of Fremanezumab Compared With Placebo for Prevention of Episodic Migraine: A Randomized Clinical Trial. JAMA. 2018 May 15;319(19):1999-2008. doi: 10.1001/jama.2018.4853.