Comparing Efficacy and Safety of 2 Dose Regimens of Subcutaneous Administration of TEV-48125 Versus Placebo for the Preventive Treatment of Chronic Migraine
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
2 other identifiers
interventional
1,130
9 countries
273
Brief Summary
The study is being conducted to evaluate two doses of TEV-48125 in adult patients with chronic migraine
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2016
Shorter than P25 for phase_3
273 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 2, 2015
CompletedFirst Posted
Study publicly available on registry
December 4, 2015
CompletedStudy Start
First participant enrolled
March 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 11, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 11, 2017
CompletedResults Posted
Study results publicly available
December 6, 2018
CompletedNovember 9, 2021
November 1, 2021
1.1 years
December 2, 2015
October 10, 2018
November 6, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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
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.
Baseline (Days -28 to Day -1), Treatment (Days 1 - Week 12)
Participants With Treatment-Emergent Adverse Events (TEAEs)
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.
Day 1 to Week 12
Secondary Outcomes (13)
Change From Baseline in the Monthly Average Number of Migraine Days During the 12-Week Period After the First Dose of Study Drug
Baseline (Days -28 to Day -1), Treatment (Days 1 - Week 12)
Percentage of Participants With At Least 50% Reduction In Monthly Average Number of Headache Days of At Least Moderate Severity
Baseline (Days -28 to Day -1), Treatment: Month 1, Month 2, Month 3, Month 1-3 (Days 1 - Week 12)
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
Baseline (Days -28 to Day -1), Treatment (Days 1 - Week 12)
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
Baseline (Days -28 to Day -1), Treatment (Days 1 - Week 4)
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
Baseline (Days -28 to Day -1), Treatment (Days 1 - Week 12)
- +8 more secondary outcomes
Study Arms (3)
Placebo
PLACEBO COMPARATORMatching Placebo
Fremanezumab 675 mg/placebo/placebo
EXPERIMENTALParticipants 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.
Fremanezumab 675/225/225 mg
EXPERIMENTALParticipants 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.
Interventions
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.
Placebo 1.5 mL pre-filled syringes identical in appearance to active intervention. Study drug was administered at the clinical site.
Eligibility Criteria
You may qualify if:
- 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
- % e-diary compliance
- Total body weight between 99 and 250 lbs, inclusive
- Additional criteria apply, please contact the investigator for more information
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (273)
Teva Investigational Site 13628
Birmingham, Alabama, 35211, United States
Teva Investigational Site 13577
Birmingham, Alabama, 35216, United States
Teva Investigational Site 13577
Birmingham, Alabama, United States
Teva Investigational Site 13628
Birmingham, Alabama, United States
Teva Investigational Site 13606
Phoenix, Arizona, 85018, United States
Teva Investigational Site 13579
Phoenix, Arizona, 85023, United States
Teva Investigational Site 13579
Phoenix, Arizona, United States
Teva Investigational Site 13606
Phoenix, Arizona, United States
Teva Investigational Site 13602
Little Rock, Arkansas, 72205, United States
Teva Investigational Site 13602
Little Rock, Arkansas, United States
Teva Investigational Site 13568
Encino, California, 91316, United States
Teva Investigational Site 13568
Encino, California, United States
Teva Investigational Site 13546
Fullerton, California, 92835, United States
Teva Investigational Site 13546
Fullerton, California, United States
Teva Investigational Site 13540
Long Beach, California, 90806, United States
Teva Investigational Site 13540
Long Beach, California, United States
Teva Investigational Site 13632
Redlands, California, 92374, United States
Teva Investigational Site 13632
Redlands, California, United States
Teva Investigational Site 13571
Redondo Beach, California, 90277, United States
Teva Investigational Site 13571
Redondo Beach, California, United States
Teva Investigational Site 13573
San Diego, California, 92103, United States
Teva Investigational Site 13573
San Diego, California, United States
Teva Investigational Site 13538
Santa Monica, California, 90404, United States
Teva Investigational Site 13538
Santa Monica, California, United States
Teva Investigational Site 13594
Santa Rosa, California, 95405, United States
Teva Investigational Site 13594
Santa Rosa, California, United States
Teva Investigational Site 13595
Walnut Creek, California, 94598, United States
Teva Investigational Site 13595
Walnut Creek, California, United States
Teva Investigational Site 13629
Aurora, Colorado, 80014, United States
Teva Investigational Site 13629
Aurora, Colorado, United States
Teva Investigational Site 13557
Boulder, Colorado, 80301, United States
Teva Investigational Site 13557
Boulder, Colorado, United States
Teva Investigational Site 13593
Colorado Springs, Colorado, 80918, United States
Teva Investigational Site 13593
Colorado Springs, Colorado, United States
Teva Investigational Site 13633
Denver, Colorado, 80210, United States
Teva Investigational Site 13612
Denver, Colorado, 80239, United States
Teva Investigational Site 13612
Denver, Colorado, United States
Teva Investigational Site 13633
Denver, Colorado, United States
Teva Investigational Site 13631
Englewood, Colorado, 80113, United States
Teva Investigational Site 13631
Englewood, Colorado, United States
Teva Investigational Site 13563
East Hartford, Connecticut, 06118, United States
Teva Investigational Site 13563
East Hartford, Connecticut, United States
Teva Investigational Site 13550
Stamford, Connecticut, 06905, United States
Teva Investigational Site 13550
Stamford, Connecticut, United States
Teva Investigational Site 13635
Bradenton, Florida, 34201, United States
Teva Investigational Site 13635
Bradenton, Florida, United States
Teva Investigational Site 13597
Gainesville, Florida, 32607, United States
Teva Investigational Site 13597
Gainesville, Florida, United States
Teva Investigational Site 13607
Hialeah, Florida, 33012, United States
Teva Investigational Site 13607
Hialeah, Florida, United States
Teva Investigational Site 13559
Jacksonville, Florida, 32205, United States
Teva Investigational Site 13559
Jacksonville, Florida, United States
Teva Investigational Site 13584
Ocala, Florida, 34471, United States
Teva Investigational Site 13584
Ocala, Florida, United States
Teva Investigational Site 13587
Orlando, Florida, 32806, United States
Teva Investigational Site 13599
Orlando, Florida, 32819, United States
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, 33410, United States
Teva Investigational Site 13567
Palm Beach Gardens, Florida, United States
Teva Investigational Site 13553
Pembroke Pines, Florida, 33026, United States
Teva Investigational Site 13553
Pembroke Pines, Florida, United States
Teva Investigational Site 13616
Pinellas Park, Florida, 33781, United States
Teva Investigational Site 13616
Pinellas Park, Florida, United States
Teva Investigational Site 13620
Atlanta, Georgia, 30312, United States
Teva Investigational Site 13537
Atlanta, Georgia, 30342, United States
Teva Investigational Site 13537
Atlanta, Georgia, United States
Teva Investigational Site 13620
Atlanta, Georgia, United States
Teva Investigational Site 13604
Boise, Idaho, United States
Teva Investigational Site 13604
Meridian, Idaho, 83642, United States
Teva Investigational Site 13585
Chicago, Illinois, 60607, United States
Teva Investigational Site 13621
Chicago, Illinois, 60654, United States
Teva Investigational Site 13585
Chicago, Illinois, United States
Teva Investigational Site 13621
Chicago, Illinois, United States
Teva Investigational Site 13627
Evanston, Illinois, 60201, United States
Teva Investigational Site 13627
Evanston, Illinois, United States
Teva Investigational Site 13596
Indianapolis, Indiana, 46254, United States
Teva Investigational Site 13596
Indianapolis, Indiana, United States
Teva Investigational Site 13617
Wichita, Kansas, 67207, United States
Teva Investigational Site 13598
Wichita, Kansas, 67211, United States
Teva Investigational Site 13598
Wichita, Kansas, United States
Teva Investigational Site 13617
Wichita, Kansas, United States
Teva Investigational Site 13566
Louisville, Kentucky, 40207, United States
Teva Investigational Site 13566
Louisville, Kentucky, United States
Teva Investigational Site 13603
Metairie, Louisiana, 70006, United States
Teva Investigational Site 13603
Metairie, Louisiana, United States
Teva Investigational Site 13582
Baltimore, Maryland, United States
Teva Investigational Site 13582
Pikesville, Maryland, 21208, United States
Teva Investigational Site 13590
Boston, Massachusetts, 02131, United States
Teva Investigational Site 13590
Boston, Massachusetts, United States
Teva Investigational Site 13589
New Bedford, Massachusetts, 02301, United States
Teva Investigational Site 13589
New Bedford, Massachusetts, United States
Teva Investigational Site 13543
Watertown, Massachusetts, 02472, United States
Teva Investigational Site 13543
Watertown, Massachusetts, United States
Teva Investigational Site 13539
Ann Arbor, Michigan, 48104, United States
Teva Investigational Site 13539
Ann Arbor, Michigan, United States
Teva Investigational Site 13542
Golden Valley, Minnesota, 55422, United States
Teva Investigational Site 13542
Golden Valley, Minnesota, United States
Teva Investigational Site 13534
Kansas City, Missouri, 64114, United States
Teva Investigational Site 13534
Kansas City, Missouri, United States
Teva Investigational Site 13536
Springfield, Missouri, United States
Teva Investigational Site 13619
St Louis, Missouri, 63141, United States
Teva Investigational Site 13619
St Louis, Missouri, United States
Teva Investigational Site 13618
Fremont, Nebraska, 68025, United States
Teva Investigational Site 13618
Fremont, Nebraska, United States
Teva Investigational Site 13605
Las Vegas, Nevada, 89106, United States
Teva Investigational Site 13605
Las Vegas, Nevada, United States
Teva Investigational Site 13578
Lebanon, New Hampshire, 03756, United States
Teva Investigational Site 13578
Lebanon, New Hampshire, United States
Teva Investigational Site 13575
Martinsville, New Jersey, United States
Teva Investigational Site 13575
Raritan, New Jersey, 08869, United States
Teva Investigational Site 13588
Albuquerque, New Mexico, 87102, United States
Teva Investigational Site 13588
Albuquerque, New Mexico, United States
Teva Investigational Site 13576
Amherst, New York, 14226, United States
Teva Investigational Site 13576
Amherst, New York, United States
Teva Investigational Site 13565
Plainview, New York, 11803, United States
Teva Investigational Site 13565
Plainview, New York, United States
Teva Investigational Site 13544
Greensboro, North Carolina, 27401, United States
Teva Investigational Site 13574
Greensboro, North Carolina, 27408, United States
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, 27607, United States
Teva Investigational Site 13545
Raleigh, North Carolina, United States
Teva Investigational Site 13609
Akron, Ohio, 44311, United States
Teva Investigational Site 13634
Akron, Ohio, 44311, United States
Teva Investigational Site 13609
Akron, Ohio, United States
Teva Investigational Site 13634
Akron, Ohio, United States
Teva Investigational Site 13533
Cincinnati, Ohio, 45227, United States
Teva Investigational Site 13624
Cincinnati, Ohio, 45249, United States
Teva Investigational Site 13533
Cincinnati, Ohio, United States
Teva Investigational Site 13624
Cincinnati, Ohio, United States
Teva Investigational Site 13569
Cleveland, Ohio, 44195, United States
Teva Investigational Site 13569
Cleveland, Ohio, United States
Teva Investigational Site 13626
Columbus, Ohio, 43212, United States
Teva Investigational Site 13626
Columbus, Ohio, United States
Teva Investigational Site 13625
Mogadore, Ohio, 44260, United States
Teva Investigational Site 13625
Mogadore, Ohio, United States
Teva Investigational Site 13561
Oklahoma City, Oklahoma, 73112, United States
Teva Investigational Site 13561
Oklahoma City, Oklahoma, United States
Teva Investigational Site 13601
Eugene, Oregon, 97401, United States
Teva Investigational Site 13601
Eugene, Oregon, United States
Teva Investigational Site 13591
Jenkintown, Pennsylvania, 19046, United States
Teva Investigational Site 13591
Jenkintown, Pennsylvania, United States
Teva Investigational Site 13554
Philadelphia, Pennsylvania, 19107, United States
Teva Investigational Site 13554
Philadelphia, Pennsylvania, United States
Teva Investigational Site 13608
Uniontown, Pennsylvania, 15401, United States
Teva Investigational Site 13608
Uniontown, Pennsylvania, United States
Teva Investigational Site 13615
Greer, South Carolina, 29650, United States
Teva Investigational Site 13615
Greer, South Carolina, United States
Teva Investigational Site 13556
Mt. Pleasant, South Carolina, 29464, United States
Teva Investigational Site 13556
Mt. Pleasant, South Carolina, United States
Teva Investigational Site 13560
Bristol, Tennessee, 37620, United States
Teva Investigational Site 13560
Bristol, Tennessee, United States
Teva Investigational Site 13532
Nashville, Tennessee, 37203, United States
Teva Investigational Site 13552
Nashville, Tennessee, 37203, United States
Teva Investigational Site 13532
Nashville, Tennessee, United States
Teva Investigational Site 13552
Nashville, Tennessee, United States
Teva Investigational Site 13541
Austin, Texas, 78731, United States
Teva Investigational Site 13541
Austin, Texas, United States
Teva Investigational Site 13623
Dallas, Texas, 75214, United States
Teva Investigational Site 13623
Dallas, Texas, United States
Teva Investigational Site 13611
Plano, Texas, 75024, United States
Teva Investigational Site 13611
Plano, Texas, United States
Teva Investigational Site 13572
San Antonio, Texas, 78229, United States
Teva Investigational Site 13572
San Antonio, Texas, United States
Teva Investigational Site 13614
Murray, Utah, 84107, United States
Teva Investigational Site 13614
Murray, Utah, United States
Teva Investigational Site 13581
West Jordan, Utah, 84088, United States
Teva Investigational Site 13581
West Jordan, Utah, United States
Teva Investigational Site 13630
Virginia Beach, Virginia, 23454, United States
Teva Investigational Site 13630
Virginia Beach, Virginia, United States
Teva Investigational Site 13564
Seattle, Washington, 98105, United States
Teva Investigational Site 13586
Seattle, Washington, 98105, United States
Teva Investigational Site 13564
Seattle, Washington, United States
Teva Investigational Site 13586
Seattle, Washington, United States
Teva Investigational Site 13600
Morgantown, West Virginia, 26506, United States
Teva Investigational Site 13600
Morgantown, West Virginia, United States
Teva Investigational Site 11124
Hamilton, Ontario, L8N 1Y2, Canada
Teva Investigational Site 11124
Hamilton, Ontario, Canada
Teva Investigational Site 11120
Calgary, T3M 1M4, Canada
Teva Investigational Site 11120
Calgary, Canada
Teva Investigational Site 11121
Montreal, H2W 1V1, Canada
Teva Investigational Site 11121
Montreal, Canada
Teva Investigational Site 11122
Newmarket, L3Y5G8, Canada
Teva Investigational Site 11122
Newmarket, Canada
Teva Investigational Site 11123
Sarnia, N7T 4X3, Canada
Teva Investigational Site 11123
Sarnia, Canada
Teva Investigational Site 54144
Brno, 602 00, Czechia
Teva Investigational Site 54144
Brno, Czechia
Teva Investigational Site 54141
Kunratice, 14800, Czechia
Teva Investigational Site 54141
Kunratice, Czechia
Teva Investigational Site 54145
Pardubice, 53002, Czechia
Teva Investigational Site 54145
Pardubice, Czechia
Teva Investigational Site 54143
Prague, 100 00, Czechia
Teva Investigational Site 54146
Prague, 130 00, Czechia
Teva Investigational Site 54142
Prague, 140 59, Czechia
Teva Investigational Site 54142
Prague, Czechia
Teva Investigational Site 54143
Prague, Czechia
Teva Investigational Site 54146
Prague, Czechia
Teva Investigational Site 40018
Helsinki, 00100, Finland
Teva Investigational Site 40017
Helsinki, 00930, Finland
Teva Investigational Site 40017
Helsinki, Finland
Teva Investigational Site 40018
Helsinki, Finland
Teva Investigational Site 40016
Turku, 20100, Finland
Teva Investigational Site 40016
Turku, Finland
Teva Investigational Site 80096
Holon, 58100, Israel
Teva Investigational Site 80096
Holon, Israel
Teva Investigational Site 80099
Jerusalem, 9112001, Israel
Teva Investigational Site 80099
Jerusalem, Israel
Teva Investigational Site 80098
Nahariya, 221001, Israel
Teva Investigational Site 80097
Netanya, 4244916, Israel
Teva Investigational Site 80097
Netanya, Israel
Teva Investigational Site 80100
Ramat Gan, 5262160, Israel
Teva Investigational Site 80100
Ramat Gan, Israel
Teva Investigational Site 80095
Tel Aviv, 64239, Israel
Teva Investigational Site 84072
Chofu-shi, 182-0006, Japan
Teva Investigational Site 84064
Chofu-shi, Japan
Teva Investigational Site 84072
Chofu-shi, Japan
Teva Investigational Site 84066
Kagoshima, 892-0844, Japan
Teva Investigational Site 84066
Kagoshima, Japan
Teva Investigational Site 84069
Kai, 400-0124, Japan
Teva Investigational Site 84069
Kaisho, Japan
Teva Investigational Site 84073
Kawasaki, 211-8588, Japan
Teva Investigational Site 84073
Kawasaki-shi, Japan
Teva Investigational Site 84067
Kyoto, 600-8811, Japan
Teva Investigational Site 84067
Kyoto, Japan
Teva Investigational Site 84062
Osaka, 556-0015, Japan
Teva Investigational Site 84062
Osaka, Japan
Teva Investigational Site 84070
Saitama, 338-8577, Japan
Teva Investigational Site 84070
Saitama-shi, Japan
Teva Investigational Site 84061
Sendai, 982-0014, Japan
Teva Investigational Site 84061
Sendai, Japan
Teva Investigational Site 84065
Shimotsuma, Japan
Teva Investigational Site 84068
Shizuoka, 4200-853, Japan
Teva Investigational Site 84068
Shizuoka, Japan
Teva Investigational Site 84065
Tochigi, 321-0293, Japan
Teva Investigational Site 84064
Tokyo, 182-0006, Japan
Teva Investigational Site 84071
Toyonaka, Japan
Teva Investigational Site 84071
Toyonaka-shi, Japan
Teva Investigational Site 53364
Krakow, 31-523, Poland
Teva Investigational Site 53363
Krakow, 33-332, Poland
Teva Investigational Site 53363
Krakow, Poland
Teva Investigational Site 53364
Krakow, Poland
Teva Investigational Site 53366
Lublin, 20-022, Poland
Teva Investigational Site 53366
Lublin, Poland
Teva Investigational Site 53365
Poznan, 60-529, Poland
Teva Investigational Site 53365
Poznan, Poland
Teva Investigational Site 53367
Warsaw, 04-730, Poland
Teva Investigational Site 53367
Warsaw, Poland
Teva Investigational Site 50399
Kazan', 420012, Russia
Teva Investigational Site 50395
Kazan', 420021, Russia
Teva Investigational Site 50395
Kazan', Russia
Teva Investigational Site 50399
Kazan', Russia
Teva Investigational Site 50394
Moscow, 121467, Russia
Teva Investigational Site 50400
Moscow, 129128, Russia
Teva Investigational Site 50394
Moscow, Russia
Teva Investigational Site 50400
Moscow, Russia
Teva Investigational Site 50398
Nizhny Novgorod, 603126, Russia
Teva Investigational Site 50396
Nizhny Novgorod, 603137, Russia
Teva Investigational Site 50396
Nizhny Novgorod, Russia
Teva Investigational Site 50398
Nizhny Novgorod, Russia
Teva Investigational Site 50397
Ufa, 450007, Russia
Teva Investigational Site 50397
Ufa, Russia
Teva Investigational Site 31207
Madrid, 28046, Spain
Teva Investigational Site 31207
Madrid, Spain
Teva Investigational Site 31208
Pamplona, 31008, Spain
Teva Investigational Site 31208
Pamplona, Spain
Teva Investigational Site 31205
Valladolid, 47003, Spain
Teva Investigational Site 31205
Valladolid, Spain
Teva Investigational Site 31206
Zaragoza, 50009, Spain
Teva Investigational Site 31206
Zaragoza, Spain
Related Publications (8)
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.
PMID: 36038833DERIVEDDiener 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.
PMID: 35331009DERIVEDNahas 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.
PMID: 34819017DERIVEDSilberstein 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.
PMID: 33413075DERIVEDSilberstein SD, Cohen JM, Seminerio MJ, Yang R, Ashina S, Katsarava Z. The impact of fremanezumab on medication overuse in patients with chronic migraine: subgroup analysis of the HALO CM study. J Headache Pain. 2020 Sep 21;21(1):114. doi: 10.1186/s10194-020-01173-8.
PMID: 32958075DERIVEDLipton RB, Cohen JM, Gandhi SK, Yang R, Yeung PP, Buse DC. Effect of fremanezumab on quality of life and productivity in patients with chronic migraine. Neurology. 2020 Aug 18;95(7):e878-e888. doi: 10.1212/WNL.0000000000010000. Epub 2020 Aug 3.
PMID: 32747522DERIVEDWinner PK, Spierings ELH, Yeung PP, Aycardi E, Blankenbiller T, Grozinski-Wolff M, Yang R, Ma Y. Early Onset of Efficacy With Fremanezumab for the Preventive Treatment of Chronic Migraine. Headache. 2019 Nov;59(10):1743-1752. doi: 10.1111/head.13654. Epub 2019 Nov 1.
PMID: 31675102DERIVEDSilberstein SD, Dodick DW, Bigal ME, Yeung PP, Goadsby PJ, Blankenbiller T, Grozinski-Wolff M, Yang R, Ma Y, Aycardi E. Fremanezumab for the Preventive Treatment of Chronic Migraine. N Engl J Med. 2017 Nov 30;377(22):2113-2122. doi: 10.1056/NEJMoa1709038.
PMID: 29171818DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director, Clinical Research
- Organization
- Teva Branded Pharmaceutical Products, R&D Inc
Study Officials
- STUDY DIRECTOR
Teva Medical Expert, MD
Teva Branded Pharmaceutical Products R&D, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2015
First Posted
December 4, 2015
Study Start
March 22, 2016
Primary Completion
April 11, 2017
Study Completion
April 11, 2017
Last Updated
November 9, 2021
Results First Posted
December 6, 2018
Record last verified: 2021-11