Efficacy and Safety of Subcutaneous Administration of Fremanezumab (TEV-48125) for the Preventive Treatment of Migraine

NCT02638103 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: TV48125-CNS-300512015-004550-18
• Study Type: interventional
• Target: 1,890
• Locations: 9 countries
• Sites: 139

Brief Summary

A study to evaluate the long-term safety, tolerability, and efficacy of subcutaneous (SC) administration of TEV-48125 in adult participants with chronic migraine (CM) or episodic migraine (EM). Participants with CM or EM who complete the pivotal efficacy studies of TEV-48125 (TV48125-CNS-30049 \[NCT02621931\] and TV48125-CNS-30050 \[NCT02629861\]) and agree to participate in this study; and new participants meeting eligibility criteria (not rolling over from pivotal studies), will be enrolled in this study.

Conditions

Migraine

Outcome Measures

Primary Outcomes (9)

• Number of Participants With Adverse Events (AEs)

  An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severe AE was defined as inability to carry out usual activities. Treatment-related AEs were defined as AEs with possible, probable, definite, or missing relationship to study drug. Serious AEs were defined as death, a life-threatening AE, 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 participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

  Baseline (Day 0) up to follow-up visit (Day 533)

• Number of Participants With Potentially Clinically Significant Abnormal Serum Chemistry Results

  Potentially clinically significant abnormal serum chemistry findings included: Blood Urea Nitrogen (BUN): greater than or equal to (\>=) 10.71 millimoles/liter (mmol/L), creatinine: \>=177 micromoles/liter (µmol/L), bilirubin: \>=34.2 µmol/L, Alanine Aminotransferase (ALT) (units/liter \[U/L\]): \>=3\*upper limit of normal (ULN) Aspartate Aminotransferase (AST) (U/L): \>=3\*ULN, and Gamma Glutamyl Transferase (GGT) (U/L): \>=3\*ULN. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

  Baseline (Day 0) up to end of treatment (EOT) visit (Day 336)

• Number of Participants With Potentially Clinically Significant Abnormal Hematology Results

  Potentially clinically significant abnormal hematology findings included: hemoglobin: less than (\<) 115 grams/liter (g/L) (in males) or less than or equal to (\<=) 95 g/L (in females), hematocrit: \<0.37 L/L (in male) or \<0.32 L/L (in female), leukocytes: \>=20\*10\^9/L or \<=3\*10\^9/L, eosinophils/leukocytes: \>=10%, and platelets: \>=700\*10\^9/L or \<=75\*10\^9/L. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

  Baseline (Day 0) up to EOT visit (Day 336)

• Number of Participants With Potentially Clinically Significant Abnormal Urinalysis Laboratory Tests Results

  Potentially clinically significant abnormal urinalysis findings included: blood: \>=2 unit increase from baseline, urine glucose (milligrams/decilitre \[mg/dL\]): \>=2 unit increase from baseline, ketones (mg/dL): \>=2 unit increase from baseline, urine protein (mg/dL): \>=2 unit increase from baseline. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

  Baseline (Day 0) up to EOT visit (Day 336)

• Number of Participants With Potentially Clinically Significant Abnormal Vital Signs Values

  Potentially clinically significant abnormal vital signs findings included: pulse rate: \<=50 beats/minute (bpm) and decrease of \>=15 bpm, or \>=120 bpm and increase of \>=15 bpm; systolic blood pressure: \<=90 millimeters of mercury (mmHg) and decrease of \>=20 mmHg, or \>=180 mmHg and increase of \>=20 mmHg; diastolic blood pressure: \<=50 mmHg and decrease of \>=15 mmHg or \>=105 mmHg and increase of \>=15 mmHg; respiratory rate: \<10 breaths/minute; and body temperature \>=38.3 degrees centigrade and change of \>=1.1 degrees centigrade. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

  Baseline (Day 0) up to EOT visit (Day 336)

• Number of Participants With Shift From Baseline to Endpoint in Electrocardiogram (ECG) Parameters

  ECG parameters included: heart rate, PR interval, QRS interval, QT interval corrected using the Fridericia formula (QTcF), QT interval corrected using the Bazett's formula (QTcB) and RR interval. Shifts represented as Baseline - endpoint value (last observed post-baseline value). Abnormal NCS indicated an abnormal but not clinically significant finding. Abnormal CS indicated an abnormal and clinically significant finding. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

  Baseline (Day 0), endpoint (Day 336)

• Number of Participants With Shift From Baseline to Endpoint in Coagulation Laboratory Test Results

  Coagulation parameters included: prothrombin time (PT) (seconds), prothrombin international normalized ratio (INR), activated partial thromboplastin time (aPTT) (seconds). Shifts represented as Baseline - endpoint value (last observed post-baseline value). Shifts from baseline to endpoint were summarized using participant 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). A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

  Baseline (Day 0), endpoint (Day 336)

• Number of Participants With Injection Site Reactions

  Number of participants who reported treatment-emergent injection site reactions are summarized. Preferred terms from MedDRA version 18.1 were offered without a threshold applied. Injection site reactions included injection site induration, pain, erythema, haemorrhage, pruritus, swelling, bruising, rash, urticaria, warmth, dermatitis, haematoma, inflammation, discolouration, discomfort, hypersensitivity, hypoaesthesia, irritation, oedema, papule, paraesthesia, vesicles and pallor. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

  Baseline (Day -28 to Day -1), Month 12

• Number of Participants With Suicidal Ideation and Suicidal Behavior as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS)

  eC-SSRS is a questionnaire to assess suicidal ideation and suicidal behavior. Suicidal behavior was 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 was defined as a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent, any self-injurious behavior with no suicidal intent.

  Baseline (Day -28 to Day -1), Month 12

Other Outcomes (4)

• Change From Baseline in Monthly Average Number of Migraine Days During the 4-Week Period at Month 12

  Baseline (Day -28 to Day -1), Month 12

• Change From Baseline in Monthly Average Number of Headache Days of Any Severity During the 4-Week Period at Month 12

  Baseline (Day -28 to Day -1), Month 12

• Percentage of Participants With At Least 50% Reduction From Baseline in Monthly Average Number of Migraine Days During the 4-Week Period at Month 12

  Baseline (Day -28 to Day -1), Month 12

Study Arms (4)

TEV-48125 225 mg Monthly: New/Placebo Rollover Participants

EXPERIMENTAL

Participants with CM who were randomized to the placebo treatment group or participants who do not rollover from the pivotal efficacy study, will receive fremanezumab 675 milligrams (mg) SC as loading dose (3 injections of fremanezumab 225 mg/1.5 milliliters \[mL\] on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the placebo treatment group or participants who do not rollover from the pivotal efficacy study, will receive 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).

Drug: Fremanezumab; Drug: Placebo

TEV-48125 225 mg Monthly: Active Rollover Participants

EXPERIMENTAL

Participants with CM who were randomized to the active treatment group (Fremanezumab 675/225 mg) in the pivotal efficacy study, will receive fremanezumab 675 mg SC as loading dose (3 injections of fremanezumab 225 mg/1.5 mL on Day 0) followed by 11 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5mL and 2 injections of placebo 1.5 mL on Days 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5mL on Days 28, 56, 112, 140, 196, 224, 280, and 308). Participants with EM who were randomized to the active treatment group (Fremanezumab 225 mg) in the pivotal efficacy study, will receive 12 monthly SC doses of fremanezumab at 225 mg (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL on Days 0, 84, 168, and 252; and 1 injection of fremanezumab 225 mg/1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).

Drug: Fremanezumab; Drug: Placebo

TEV-48125 675 mg Quarterly: New/Placebo Rollover Participants

EXPERIMENTAL

Participants with CM or EM who were randomized to the placebo treatment group or participants who do not rollover from the pivotal efficacy study, will receive fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).

Drug: Fremanezumab; Drug: Placebo

TEV-48125 675 mg Quarterly: Active Rollover Participants

EXPERIMENTAL

Participants with CM or EM who were randomized to the active treatment group (Fremanezumab 675 mg) in the pivotal efficacy study, will receive fremanezumab 675 mg SC once every 3 months for 12 months for a total of 4 doses (3 injections of fremanezumab 225 mg/1.5 mL on Days 0, 84, 168, and 252; and 1 injection of placebo 1.5 mL on Days 28, 56, 112, 140, 196, 224, 280, and 308).

Drug: Fremanezumab; Drug: Placebo

Interventions

Fremanezumab DRUG

Fremanezumab will be administered as per the dose and schedule specified in the respective arms.

Also known as: TEV-48125

TEV-48125 225 mg Monthly: Active Rollover Participants; TEV-48125 225 mg Monthly: New/Placebo Rollover Participants; TEV-48125 675 mg Quarterly: Active Rollover Participants; TEV-48125 675 mg Quarterly: New/Placebo Rollover Participants

Placebo DRUG

Placebo matching to fremanezumab will be administered as per schedule specified in the respective arms.

TEV-48125 225 mg Monthly: Active Rollover Participants; TEV-48125 225 mg Monthly: New/Placebo Rollover Participants; TEV-48125 675 mg Quarterly: Active Rollover Participants; TEV-48125 675 mg Quarterly: New/Placebo Rollover Participants

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants Rolling Over from the Pivotal Efficacy Studies:
• Participant must have signed and dated the informed consent document.
• Participant must have completed the pivotal efficacy study without major protocol violations.
• Additional criteria apply, please contact the investigator for more information.
• Participants Not Rolling Over from the Pivotal Efficacy Studies:
• Males or females aged 18 to 70 years, inclusive, with migraine onset at less than or equal to (≤) 50 years of age.
• Participant signed and dated the informed consent document.
• Participant has a history of migraine or clinical judgment suggests a migraine diagnosis.
• Participant fulfills the criteria for EM or CM with prospectively collected baseline information during the 28-day run-in period.
• Body mass index (BMI) of 17.5 to 37.5 kilograms/square meter (kg/m\^2) and a total body weight between 45 and 120 kg, inclusive.
• All participants must be of non-childbearing potential.
• Participants must simultaneously use 2 forms of highly effective contraception methods.
• Participants will remain abstinent throughout the study.
• Female participants of childbearing potential must have a negative serum beta-human chorionic gonadotropin (β-HCG) pregnancy test prior at screening (confirmed by urine dipstick β-HCG pregnancy test at baseline).
• The participant must be willing and able to comply with study restrictions, to remain at the clinic for the required duration during the study period, and to return to the clinic for the follow-up evaluation.

You may not qualify if:

• Participants Rolling Over from the Pivotal Efficacy Studies:
• Pregnant or nursing females
• Compliance with daily diary entry lower than 75 percent (%) at the last month of the double-blind treatment period of the pivotal efficacy study.
• Additional criteria apply, please contact the investigator for more information.
• Participants Not Rolling Over from the Pivotal Efficacy Studies:
• Clinically significant findings 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 \[for example; cerebral ischemia\], 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 past 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 before study drug administration or 5 half-lives, whichever is longer.
• History of alcohol or drug abuse during the past 2 years, or alcohol or drug dependence during the past 5 years.
• The participant cannot participate or successfully complete the study, in the opinion of their healthcare provider or the investigator, for any of the following reasons:
• mentally or legally incapacitated or unable to give consent for any reason.

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

Study Sites (139)

Teva Investigational Site 13628

Birmingham, Alabama, 35211, United States

Location

Teva Investigational Site 13577

Birmingham, Alabama, 35216, United States

Location

Teva Investigational Site 13606

Phoenix, Arizona, 85018, United States

Location

Teva Investigational Site 13579

Phoenix, Arizona, 85023, United States

Location

Teva Investigational Site 13602

Little Rock, Arkansas, 72205, United States

Location

Teva Investigational Site 13568

Encino, California, 91316, United States

Location

Teva Investigational Site 13546

Fullerton, California, 92835, United States

Location

Teva Investigational Site 13540

Long Beach, California, 90806, United States

Location

Teva Investigational Site 13632

Redlands, California, 92374, United States

Location

Teva Investigational Site 13571

Redondo Beach, California, 90277, United States

Location

Teva Investigational Site 13573

San Diego, California, 92103, United States

Location

Teva Investigational Site 13538

Santa Monica, California, 90404, United States

Location

Teva Investigational Site 13594

Santa Rosa, California, 95405, United States

Location

Teva Investigational Site 13595

Walnut Creek, California, 94598, United States

Location

Teva Investigational Site 13629

Aurora, Colorado, 80014, United States

Location

Teva Investigational Site 13557

Boulder, Colorado, 80301, United States

Location

Teva Investigational Site 13593

Colorado Springs, Colorado, 80918, United States

Location

Teva Investigational Site 13633

Denver, Colorado, 80210, United States

Location

Teva Investigational Site 13612

Denver, Colorado, 80239, United States

Location

Teva Investigational Site 13631

Englewood, Colorado, 80113, United States

Location

Teva Investigational Site 13563

East Hartford, Connecticut, 06118, United States

Location

Teva Investigational Site 13550

Stamford, Connecticut, 06905, United States

Location

Teva Investigational Site 13635

Bradenton, Florida, 34201, United States

Location

Teva Investigational Site 13597

Gainesville, Florida, 32607, United States

Location

Teva Investigational Site 13607

Hialeah, Florida, 33012, United States

Location

Teva Investigational Site 13559

Jacksonville, Florida, 32205, United States

Location

Teva Investigational Site 13584

Ocala, Florida, 34471, United States

Location

Teva Investigational Site 13587

Orlando, Florida, 32806, United States

Location

Teva Investigational Site 13567

Palm Beach Gardens, Florida, 33410, United States

Location

Teva Investigational Site 13553

Pembroke Pines, Florida, 33026, United States

Location

Teva Investigational Site 13616

Pinellas Park, Florida, 33781, United States

Location

Teva Investigational Site 13620

Atlanta, Georgia, 30312, United States

Location

Teva Investigational Site 13537

Atlanta, Georgia, 30342, United States

Location

Teva Investigational Site 13604

Boise, Idaho, 83642, United States

Location

Teva Investigational Site 13585

Chicago, Illinois, 60607, United States

Location

Teva Investigational Site 13621

Chicago, Illinois, 60654, United States

Location

Teva Investigational Site 13627

Evanston, Illinois, 60201, United States

Location

Teva Investigational Site 13596

Indianapolis, Indiana, 46254, United States

Location

Teva Investigational Site 13617

Wichita, Kansas, 67207, United States

Location

Teva Investigational Site 13598

Wichita, Kansas, 67211, United States

Location

Teva Investigational Site 13566

Louisville, Kentucky, 40207, United States

Location

Teva Investigational Site 13603

Metairie, Louisiana, 70006, United States

Location

Teva Investigational Site 13582

Pikesville, Maryland, 21208, United States

Location

Teva Investigational Site 13590

Boston, Massachusetts, 02131, United States

Location

Teva Investigational Site 13589

New Bedford, Massachusetts, 02301, United States

Location

Teva Investigational Site 13543

Watertown, Massachusetts, 02472, United States

Location

Teva Investigational Site 13539

Ann Arbor, Michigan, 48104, United States

Location

Teva Investigational Site 13542

Golden Valley, Minnesota, 55422, United States

Location

Teva Investigational Site 13534

Kansas City, Missouri, 64114, United States

Location

Teva Investigational Site 13536

Springfield, Missouri, 65807, United States

Location

Teva Investigational Site 13619

St Louis, Missouri, 63141, United States

Location

Teva Investigational Site 13618

Fremont, Nebraska, 68025, United States

Location

Teva Investigational Site 13605

Las Vegas, Nevada, 89106, United States

Location

Teva Investigational Site 13578

Lebanon, New Hampshire, 03756, United States

Location

Teva Investigational Site 13575

Martinsville, New Jersey, 08836, United States

Location

Teva Investigational Site 13622

Princeton, New Jersey, 08540, United States

Location

Teva Investigational Site 13588

Albuquerque, New Mexico, 87102, United States

Location

Teva Investigational Site 13576

Amherst, New York, 14226, United States

Location

Teva Investigational Site 13565

Plainview, New York, 11803, United States

Location

Teva Investigational Site 13544

Greensboro, North Carolina, 27405, United States

Location

Teva Investigational Site 13574

Greensboro, North Carolina, 27408, United States

Location

Teva Investigational Site 13545

Raleigh, North Carolina, 27612, United States

Location

Teva Investigational Site 13609

Akron, Ohio, 44311, United States

Location

Teva Investigational Site 13625

Akron, Ohio, 44311, United States

Location

Teva Investigational Site 13634

Akron, Ohio, 44311, United States

Location

Teva Investigational Site 13533

Cincinnati, Ohio, 45227, United States

Location

Teva Investigational Site 13624

Cincinnati, Ohio, 45249, United States

Location

Teva Investigational Site 13569

Cleveland, Ohio, 44195, United States

Location

Teva Investigational Site 13626

Columbus, Ohio, 43212, United States

Location

Teva Investigational Site 13561

Oklahoma City, Oklahoma, 73112, United States

Location

Teva Investigational Site 13601

Eugene, Oregon, 97401, United States

Location

Teva Investigational Site 13591

Jenkintown, Pennsylvania, 19046, United States

Location

Teva Investigational Site 13554

Philadelphia, Pennsylvania, 19107, United States

Location

Teva Investigational Site 13608

Uniontown, Pennsylvania, 15401, United States

Location

Teva Investigational Site 13615

Greer, South Carolina, 29650, United States

Location

Teva Investigational Site 13556

Mt. Pleasant, South Carolina, 29464, United States

Location

Teva Investigational Site 13560

Bristol, Tennessee, 37620, United States

Location

Teva Investigational Site 13551

Memphis, Tennessee, 38119, United States

Location

Teva Investigational Site 13532

Nashville, Tennessee, 37203, United States

Location

Teva Investigational Site 13552

Nashville, Tennessee, 37203, United States

Location

Teva Investigational Site 13541

Austin, Texas, 78731, United States

Location

Teva Investigational Site 13623

Dallas, Texas, 75214, United States

Location

Teva Investigational Site 13611

Plano, Texas, 75024, United States

Location

Teva Investigational Site 13572

San Antonio, Texas, 78229, United States

Location

Teva Investigational Site 13614

Murray, Utah, 84107, United States

Location

Teva Investigational Site 13581

West Jordan, Utah, 84088, United States

Location

Teva Investigational Site 13630

Virginia Beach, Virginia, 23454, United States

Location

Teva Investigational Site 13564

Seattle, Washington, 98105, United States

Location

Teva Investigational Site 13586

Seattle, Washington, 98105, United States

Location

Teva Investigational Site 13600

Morgantown, West Virginia, 26506, United States

Location

Teva Investigational Site 11124

Hamilton, Ontario, L8N 1Y2, Canada

Location

Teva Investigational Site 11122

Newmarket, Ontario, L3Y5G8, Canada

Location

Teva Investigational Site 11120

Calgary, T3M 1M4, Canada

Location

Teva Investigational Site 11121

Montreal, H2W 1V1, Canada

Location

Teva Investigational Site 11123

Sarnia, N7T 4X3, Canada

Location

Teva Investigational Site 54144

Brno, 602 00, Czechia

Location

Teva Investigational Site 54141

Kunratice, 14800, Czechia

Location

Teva Investigational Site 54145

Pardubice, 53002, Czechia

Location

Teva Investigational Site 54143

Prague, 100 00, Czechia

Location

Teva Investigational Site 54146

Prague, 130 00, Czechia

Location

Teva Investigational Site 54142

Prague, 140 59, Czechia

Location

Teva Investigational Site 40018

Helsinki, 00180, Finland

Location

Teva Investigational Site 40017

Helsinki, 00930, Finland

Location

Teva Investigational Site 40016

Turku, 20100, Finland

Location

Teva Investigational Site 80096

Holon, 58100, Israel

Location

Teva Investigational Site 80099

Jerusalem, 9112001, Israel

Location

Teva Investigational Site 80098

Nahariya, 221001, Israel

Location

Teva Investigational Site 80097

Netanya, 4244916, Israel

Location

Teva Investigational Site 80100

Ramat Gan, 5265601, Israel

Location

Teva Investigational Site 80095

Tel Aviv, 6423906, Israel

Location

Teva Investigational Site 84072

Chofu-shi, 182-0006, Japan

Location

Teva Investigational Site 84066

Kagoshima, 892-0844, Japan

Location

Teva Investigational Site 84069

Kai, 400-0124, Japan

Location

Teva Investigational Site 84073

Kawasaki, 211-8588, Japan

Location

Teva Investigational Site 84067

Kyoto, 600-8811, Japan

Location

Teva Investigational Site 84062

Osaka, 556-0015, Japan

Location

Teva Investigational Site 84070

Saitama, 338-8577, Japan

Location

Teva Investigational Site 84061

Sendai, 982-0014, Japan

Location

Teva Investigational Site 84063

Shinjuku-ku, 160-8582, Japan

Location

Teva Investigational Site 84068

Shizuoka, 4200-853, Japan

Location

Teva Investigational Site 84065

Tochigi, 321-0293, Japan

Location

Teva Investigational Site 84064

Tokyo, 182-0006, Japan

Location

Teva Investigational Site 84071

Toyonaka, Japan

Location

Teva Investigational Site 53364

Krakow, 31-523, Poland

Location

Teva Investigational Site 53363

Krakow, 33-332, Poland

Location

Teva Investigational Site 53366

Lublin, 20-022, Poland

Location

Teva Investigational Site 53365

Poznan, 60-529, Poland

Location

Teva Investigational Site 53367

Warsaw, 04-730, Poland

Location

Teva Investigational Site 50399

Kazan', 420012, Russia

Location

Teva Investigational Site 50395

Kazan', 420021, Russia

Location

Teva Investigational Site 50394

Moscow, 121467, Russia

Location

Teva Investigational Site 50400

Moscow, 129128, Russia

Location

Teva Investigational Site 50398

Nizhny Novgorod, 603126, Russia

Location

Teva Investigational Site 50396

Nizhny Novgorod, 603137, Russia

Location

Teva Investigational Site 50397

Ufa, 450007, Russia

Location

Teva Investigational Site 31207

Madrid, 28046, Spain

Location

Teva Investigational Site 31208

Pamplona, 31008, Spain

Location

Teva Investigational Site 31205

Valladolid, 47003, Spain

Location

Teva Investigational Site 31206

Zaragoza, 50009, Spain

Location

Related Publications (2)

• Goadsby PJ, Silberstein SD, Yeung PP, Cohen JM, Ning X, Yang R, Dodick DW. Long-term safety, tolerability, and efficacy of fremanezumab in migraine: A randomized study. Neurology. 2020 Nov 3;95(18):e2487-e2499. doi: 10.1212/WNL.0000000000010600. Epub 2020 Sep 10.

  PMID: 32913018 DERIVED

• Buse DC, Gandhi SK, Cohen JM, Ramirez-Campos V, Cloud B, Yang R, Cowan RP. Improvements across a range of patient-reported domains with fremanezumab treatment: results from a patient survey study. J Headache Pain. 2020 Sep 4;21(1):109. doi: 10.1186/s10194-020-01177-4.

  PMID: 32887548 DERIVED

MeSH Terms

Conditions

Migraine Disorders

Interventions

fremanezumab

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Director, Clinical Research
• Organization: Teva Branded Pharmaceutical Products, R&D Inc.

USMedInfo@tevapharm.com

1-888-483-8279

Study Officials

• Teva Medical Expert, MD

  Teva Branded Pharmaceutical Products R&D, Inc.

  STUDY DIRECTOR

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
• Expanded Access: Yes

Study Record Dates

• First Submitted: December 18, 2015
• First Posted: December 22, 2015
• Study Start: February 26, 2016
• Primary Completion: June 6, 2018
• Study Completion: December 8, 2018
• Last Updated: November 9, 2021
• Results First Posted: August 28, 2019

Record last verified: 2021-11

Locations

RU (7); CA (5); JP (13); ES (4); US (90); CZ (6); PL (5); FI (3); IL (6)