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An Efficacy and Safety Study of Fremanezumab in Adults With Migraine (FOCUS)

Primary Purpose

Migraine Prophylaxis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Fremanezumab

Placebo

About this trial

This is an interventional treatment trial for Migraine Prophylaxis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

The participant has a diagnosis of migraine with onset at ≤50 years of age.
Body weight ≥45 kilograms.
The participant has a history of migraine for ≥12 months prior to screening.
Women of childbearing potential (WOCBP) whose male partners are potentially fertile (that is; no vasectomy) must use highly effective birth control methods for the duration of the study and the follow-up period and for 6.0 months after discontinuation of investigational medicinal product (IMP)
Men must be sterile, or if they are potentially fertile/reproductively competent (not surgically [that is; vasectomy] or congenitally sterile) and their female partners are of childbearing potential, must use, together with their female partners, acceptable birth control methods for the duration of the study and for 6.0 months after discontinuation of the investigational medicinal product (IMP).
- Additional criteria apply, please contact the investigator for more information.

Exclusion Criteria:

At the time of screening visit, participant is receiving any preventive migraine medications, regardless of the medical indication for more than 5 days and expects to continue with these medications.
Participant has received onabotulinumtoxinA for migraine or for any medical or cosmetic reasons requiring injections in the head, face, or neck during the 3 months before screening visit.
The participant has used an intervention/device (for example; scheduled nerve blocks and transcranial magnetic stimulation) for migraine during the 2 months prior to screening.
The participant uses triptans/ergots as preventive therapies for migraine.
Participant uses non-steroidal anti-inflammatory drugs (NSAIDs) as preventive therapy for migraine on nearly daily basis for other indications. Note: Low dose aspirin (for example; 81 mg) used for cardiovascular disease prevention is allowed.
- Additional criteria apply, please contact the investigator for more information.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Fremanezumab Quarterly

Fremanezumab Monthly

Arm Description

Double-blind (DB) period: Participants with CM or EM will receive 3 injections of placebo 1.5 milliliters (mL) SC on Day 0 and single injection of placebo 1.5 mL SC on Days 28 and 56. Open-label (OL) period: Participants with CM or EM will receive fremanezumab (TEV-48125) 225 milligrams (mg) SC (1 injection of fremanezumab 225 mg/1.5 mL) at Days 84, 112, and 140.

DB period: Participants with CM or EM will receive fremanezumab 675 mg SC (3 injections of fremanezumab 225 mg/1.5 mL) on Day 0 followed by monthly SC administration of placebo 1.5 mL for 2 months (on Days 28 and 56). OL period: Participants with CM or EM will receive fremanezumab 225 mg SC (1 injection of fremanezumab 225 mg/1.5 mL) at Days 84, 112, and 140.

DB period: Participants with CM will receive fremanezumab 675 mg SC (3 injections of fremanezumab 225 mg/1.5 mL) on Day 0 followed by monthly SC administration of fremanezumab 225 mg (1 injection of fremanezumab 225 mg/1.5 mL) for 2 months (on Days 28 and 56). Participants with EM will receive fremanezumab 225 mg SC (1 injection of fremanezumab 225 mg/1.5 mL and 2 injections of placebo 1.5 mL) on Day 0 followed by monthly SC administration of fremanezumab 225 mg (1 injection of fremanezumab 225 mg/1.5 mL) for 2 months (on Days 28 and 56). OL period: Participants with CM or EM will receive fremanezumab 225 mg SC (1 injection of fremanezumab 225 mg/1.5 mL) at Days 84, 112, and 140.

Outcomes

Primary Outcome Measures

DB Period: Change From Baseline in Monthly Average Number of Migraine Days During the 12-Week Period After the First Dose of Fremanezumab

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 meeting criteria for migraine with or without aura; a calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours of a headache meeting criteria for probable migraine, a migraine subtype where only 1 migraine criterion was 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 were derived and normalized to 28 days equivalent by formula: (number of days of efficacy variable over relevant period/number of days with assessments recorded in e-diary over relevant period)*28. Change was calculated as post-baseline value - baseline value.

Secondary Outcome Measures

DB Period: Percentage of Participants Reaching at Least 50 Percent (%) Reduction From Baseline in Monthly Average Number of Migraine Days During the 12-Week Period After the First Dose of Fremanezumab

DB Period: Change From Baseline in Monthly Average Number of Headache Days of at Least Moderate Severity During the 12-Week Period After the First Dose of Fremanezumab

A headache day of at least moderate severity was defined as a calendar day (00:00 to 23:59) demonstrating at least 4 consecutive hours of headache of at least moderate severity or; a calendar day (0:00 to 23:59) demonstrating a headache of any duration that was treated with migraine-specific acute medications (triptans and ergot compounds). Monthly averages were derived and normalized to 28 days equivalent by the following formula: (number of days of efficacy variable over relevant period/number of days with assessments recorded in the e-diary over the relevant period) * 28. The change was calculated as post-baseline value - baseline value. LS mean calculated using ANCOVA model with treatment, gender, region, special group of treatment failure (yes/no), migraine classification (EM/CM), and treatment*migraine classification as fixed effects and baseline number of headache days of at least moderate severity and years since onset of migraine as covariates.

DB Period: Change From Baseline in Monthly Average Number of Migraine Days During the 4-Week Period After the First Dose of Fremanezumab

A migraine day was defined as when at least 1 of following occurred: A calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours of a headache meeting criteria for migraine with or without aura; a calendar day demonstrating at least 4 consecutive hours of a headache meeting criteria for probable migraine, a migraine subtype where only 1 migraine criterion was missing; a calendar day demonstrating a headache of any duration that was treated with migraine-specific medications. Monthly averages were derived and normalized to 28 days equivalent by formula: (number of days of efficacy variable over relevant period/number of days with assessments recorded in e-diary over relevant period)*28. LS mean calculated using ANCOVA model with treatment, gender, region, special group of treatment failure (yes/no), migraine classification (EM/CM), and treatment*migraine classification as fixed effects, and baseline number of migraine days and years since onset of migraines as covariates.

DB Period: Percentage of Participants Reaching at Least 50% Reduction From Baseline in Monthly Average Number of Migraine Days During the 4-Week Period After the First Dose of Fremanezumab

DB Period: Change From Baseline in Monthly Average Number of Days of Use of Any Acute Headache Medications During the 12-Week Period After the First Dose of Fremanezumab

Baseline data and the mean change from baseline in the monthly average number of days of use of any acute headache medications during the 12-week period after administration of the first dose of study drug (based on Week 0 to 12 data) is reported. Least Squares (LS) mean calculated using analysis of covariance (ANCOVA) model with treatment, gender, region, special group of treatment failure (yes/no), migraine classification (EM/CM), and treatment*migraine classification as fixed effects, and baseline number of migraine days and years since onset of migraines as covariates.

DB Period: Change From Baseline in Monthly Average Number of Headache Days of at Least Moderate Severity During the 4-Week Period After the First Dose of Fremanezumab

A headache day of at least moderate severity was defined as a calendar day (00:00 to 23:59) demonstrating at least 4 consecutive hours of headache of at least moderate severity or; a calendar day (0:00 to 23:59) demonstrating a headache of any duration that was treated with migraine-specific acute medications (triptans and ergot compounds). Monthly averages were derived and normalized to 28 days equivalent by the following formula: (number of days of efficacy variable over relevant period/number of days with assessments recorded in the e-diary over the relevant period) * 28. The change was calculated as post-baseline value - baseline value. LS mean calculated using ANCOVA model with treatment, gender, region, special group of treatment failure (yes/no), migraine classification (EM/CM), and treatment*migraine classification as fixed effects, and baseline number of headache days of at least moderate severity and years since onset of migraines as covariates.

DB Period: Number of Participants With Adverse Events (AEs) and Who Did Not Complete the Study Due to 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.

OL Period: Number of Participants With AEs and Who Did Not Complete the Study Due to AEs

DB Period: Number of Participants With Potentially Clinically Significant Abnormal Serum Chemistry Results

Criteria for potentially clinically significant abnormal serum chemistry values included: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), gamma glutamyl transferase (GGT), and lactate dehydrogenase (LDH) (units/liter [U/L]): greater than or equal to (≥) 3*upper limit of normal (ULN); Blood Urea Nitrogen (BUN): ≥10.71 millimoles/liter (mmol/L); creatinine: ≥177 micromoles/liter (µmol/L); bilirubin (total): ≥34.2 µmol/L; and uric acid: ≥625 µmol/L (men), and ≥506 µmol/L (women). A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

OL Period: Number of Participants With Potentially Clinically Significant Abnormal Serum Chemistry Results

Criteria for potentially clinically significant abnormal serum chemistry values included: ALT, AST, ALP, GGT, and LDH (U/L): ≥3*ULN; BUN: ≥10.71 mmol/L; creatinine: ≥177 µmol/L; bilirubin (total): ≥34.2 µmol/L; and uric acid: ≥625 µmol/L (men), and ≥506 µmol/L (women). A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

DB Period: Number of Participants With Potentially Clinically Significant Abnormal Hematology Results

Criteria for potentially clinically significant abnormal hematology values included: hemoglobin: less than (<) 115 grams/liter (g/L) (in men) or less than or equal to (≤) 95 g/L (in women), hematocrit: <0.37 L/L (in men) or <0.32 L/L (in women), leukocytes: ≥20*10^9/L or ≤3*10^9/L, eosinophils: >=10%, platelets: ≥700*10^9/L or ≤75*10^9/L, and absolute neutrophil count (ANC): ≤1*10^9/L. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

OL Period: Number of Participants With Potentially Clinically Significant Abnormal Hematology Results

Criteria for potentially clinically significant abnormal hematology values included: hemoglobin: <115 g/L (in men) or ≤95 g/L (in women), hematocrit: <0.37 L/L (in men) or <0.32 L/L (in women), leukocytes: ≥20*10^9/L or ≤3*10^9/L, eosinophils: >=10%, platelets: ≥700*10^9/L or ≤75*10^9/L, and ANC: ≤1*10^9/L. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

DB Period: Number of Participants With Potentially Clinically Significant Abnormal Coagulation Laboratory Test Results

Criteria for potentially clinically significant abnormal coagulation values included: prothrombin international normalized ratio (INR): greater than (>) 1.5. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

OL Period: Number of Participants With Potentially Clinically Significant Abnormal Coagulation Laboratory Test Results

Criteria for potentially clinically significant abnormal coagulation values included: prothrombin INR: >1.5. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

DB Period: Number of Participants With Potentially Clinically Significant Abnormal Urinalysis Laboratory Tests Results

Criteria for potentially clinically significant abnormal urinalysis values included: urine glucose (milligrams/deciliter [mg/dL]): ≥2 unit increase from baseline, ketones (mg/dL): ≥2 unit increase from baseline, urine total protein (mg/dL): ≥2 unit increase from baseline, and haemoglobin ≥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.

OL Period: Number of Participants With Potentially Clinically Significant Abnormal Urinalysis Laboratory Tests Results

Criteria for potentially clinically significant abnormal urinalysis values included: urine glucose (mg/dL): ≥2 unit increase from baseline, ketones (mg/dL): ≥2 unit increase from baseline, urine total protein (mg/dL): ≥2 unit increase from baseline, and haemoglobin ≥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.

DB Period: Number of Participants With Potentially Clinically Significant Abnormal Vital Signs Values

Criteria for potentially clinically significant abnormal vital signs values 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 celsius and change of ≥1.1 degrees celsius. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

OL Period: Number of Participants With Potentially Clinically Significant Abnormal Vital Signs Values

Criteria for potentially clinically significant abnormal vital signs values included: pulse rate: ≤50 bpm and decrease of ≥15 bpm, or ≥120 bpm and increase of ≥15 bpm; systolic blood pressure: ≤90 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 celsius and change of ≥1.1 degrees celsius. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

DB Period: Number of Participants With Shift From Baseline to Week 12 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 - Week 12 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.

OL Period: Number of Participants With Shift From Baseline to Week 24 in 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 - Week 24 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.

DB Period: Number of Participants Who Received Concomitant Medications for Adverse Events

Concomitant medications included: agents acting on the renin-angiotensin system, all other therapeutic products (for example: homeopathic preparation), allergens, analgesics, anesthetics, anti-parkinson drugs, antianemic preparations, antibacterials for systemic use, antibiotics and chemotherapeutics for dermatological use, antidiarrheals, intestinal antiinflammatory/antiinfective agents, antiemetic, antiepileptics, antifungals for dermatologiocal use, antigout preparations, antihemorrhagics, antihistamines for systemic use, antihypertensives, antiinflammatory and antirheumatic products, antimycotics for systemic use, antipruritics, antipsoriatics, antivirals for systemic use, beta blocking agents, blood substitutes and perfusion solutions, cardiac therapy, corticosteroids, cough and cold preparations, diagnostic radiopharmaceuticals, diuretics, thyroid therapy, urologicals, vaccines, psycoleptics, psycoanaleptics, ophthalmologicals, muscle relaxants, drugs used in diabetes etc.

OL Period: Number of Participants Who Received Concomitant Medications for Adverse Events

Full Information

NCT ID

NCT03308968

First Posted

October 3, 2017

Last Updated

November 5, 2021

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03308968

Brief Title

An Efficacy and Safety Study of Fremanezumab in Adults With Migraine

Acronym

FOCUS

Official Title

A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study With an Open-Label Period to Evaluate the Efficacy and Safety of Fremanezumab for the Prophylactic Treatment of Migraine in Patients With Inadequate Response to Prior Preventive Treatments

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

October 13, 2017 (Actual)

Primary Completion Date

October 2, 2018 (Actual)

Study Completion Date

May 29, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of monthly and quarterly subcutaneous (sc) injections of fremanezumab compared with sc injections of placebo in participants with chronic migraine (CM) or episodic migraine (EM) who have responded inadequately to 2 to 4 classes of prior preventive treatments. Approximately equal numbers of participants from each subgroup (CM and EM) are randomized in blinded-fashion 1:1:1 into one of 3 treatments for the subgroup - 2 active treatments and 1 placebo treatment- consisting of monthly injections for 3 months (up to Week 12). Then all participants continue into an open-label extension of 3 months (up to Week 24) during which everyone is administered sc injections of fremanezumab.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Migraine Prophylaxis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

838 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Arm Title

Fremanezumab Quarterly

Arm Type

Experimental

Arm Description

Arm Title

Fremanezumab Monthly

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Fremanezumab

Other Intervention Name(s)

TEV-48125

Intervention Description

Fremanezumab will be administered per dose and schedule specified in the arm.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo matching to fremanezumab will be administered per schedule specified in the arm.

Primary Outcome Measure Information:

Title

DB Period: Change From Baseline in Monthly Average Number of Migraine Days During the 12-Week Period After the First Dose of Fremanezumab

Description

Time Frame

Baseline (Day -28 to Day -1), up to Week 12

Secondary Outcome Measure Information:

Title

Description

Time Frame

Baseline (Day -28 to Day-1), up to Week 12

Title

DB Period: Change From Baseline in Monthly Average Number of Headache Days of at Least Moderate Severity During the 12-Week Period After the First Dose of Fremanezumab

Description

Time Frame

Baseline (Day -28 to Day -1), up to Week 12

Title

DB Period: Change From Baseline in Monthly Average Number of Migraine Days During the 4-Week Period After the First Dose of Fremanezumab

Description

Time Frame

Baseline (Day -28 to Day -1), up to Week 4

Title

DB Period: Percentage of Participants Reaching at Least 50% Reduction From Baseline in Monthly Average Number of Migraine Days During the 4-Week Period After the First Dose of Fremanezumab

Description

Time Frame

Baseline (Day -28 to Day-1), up to Week 4

Title

DB Period: Change From Baseline in Monthly Average Number of Days of Use of Any Acute Headache Medications During the 12-Week Period After the First Dose of Fremanezumab

Description

Time Frame

Baseline (Day -28 to Day -1), up to Week 12

Title

DB Period: Change From Baseline in Monthly Average Number of Headache Days of at Least Moderate Severity During the 4-Week Period After the First Dose of Fremanezumab

Description

A headache day of at least moderate severity was defined as a calendar day (00:00 to 23:59) demonstrating at least 4 consecutive hours of headache of at least moderate severity or; a calendar day (0:00 to 23:59) demonstrating a headache of any duration that was treated with migraine-specific acute medications (triptans and ergot compounds). Monthly averages were derived and normalized to 28 days equivalent by the following formula: (number of days of efficacy variable over relevant period/number of days with assessments recorded in the e-diary over the relevant period) * 28. The change was calculated as post-baseline value - baseline value. LS mean calculated using ANCOVA model with treatment, gender, region, special group of treatment failure (yes/no), migraine classification (EM/CM), and treatment*migraine classification as fixed effects, and baseline number of headache days of at least moderate severity and years since onset of migraines as covariates.

Time Frame

Baseline (Day -28 to Day -1), up to Week 4

Title

DB Period: Number of Participants With Adverse Events (AEs) and Who Did Not Complete the Study Due to AEs

Description

Time Frame

Baseline (Day 0) up to Week 12

Title

OL Period: Number of Participants With AEs and Who Did Not Complete the Study Due to AEs

Description

Time Frame

Week 12 up to Week 24

Title

DB Period: Number of Participants With Potentially Clinically Significant Abnormal Serum Chemistry Results

Description

Time Frame

Baseline up to Week 12

Title

OL Period: Number of Participants With Potentially Clinically Significant Abnormal Serum Chemistry Results

Description

Time Frame

Week 12 up to Week 24

Title

DB Period: Number of Participants With Potentially Clinically Significant Abnormal Hematology Results

Description

Time Frame

Baseline up to Week 12

Title

OL Period: Number of Participants With Potentially Clinically Significant Abnormal Hematology Results

Description

Time Frame

Week 12 up to Week 24

Title

DB Period: Number of Participants With Potentially Clinically Significant Abnormal Coagulation Laboratory Test Results

Description

Time Frame

Baseline up to Week 12

Title

OL Period: Number of Participants With Potentially Clinically Significant Abnormal Coagulation Laboratory Test Results

Description

Time Frame

Week 12 up to Week 24

Title

DB Period: Number of Participants With Potentially Clinically Significant Abnormal Urinalysis Laboratory Tests Results

Description

Time Frame

Baseline up to Week 12

Title

OL Period: Number of Participants With Potentially Clinically Significant Abnormal Urinalysis Laboratory Tests Results

Description

Time Frame

Week 12 up to Week 24

Title

DB Period: Number of Participants With Potentially Clinically Significant Abnormal Vital Signs Values

Description

Time Frame

Baseline up to Week 12

Title

OL Period: Number of Participants With Potentially Clinically Significant Abnormal Vital Signs Values

Description

Time Frame

Week 12 up to Week 24

Title

DB Period: Number of Participants With Shift From Baseline to Week 12 in Electrocardiogram (ECG) Parameters

Description

Time Frame

Baseline, Week 12

Title

OL Period: Number of Participants With Shift From Baseline to Week 24 in ECG Parameters

Description

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 - Week 24 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.

Time Frame

Baseline, Week 24

Title

DB Period: Number of Participants Who Received Concomitant Medications for Adverse Events

Description

Time Frame

Baseline up to Week 12

Title

OL Period: Number of Participants Who Received Concomitant Medications for Adverse Events

Description

Time Frame

Week 12 up to Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The participant has a diagnosis of migraine with onset at ≤50 years of age. Body weight ≥45 kilograms. The participant has a history of migraine for ≥12 months prior to screening. Women of childbearing potential (WOCBP) whose male partners are potentially fertile (that is; no vasectomy) must use highly effective birth control methods for the duration of the study and the follow-up period and for 6.0 months after discontinuation of investigational medicinal product (IMP) Men must be sterile, or if they are potentially fertile/reproductively competent (not surgically [that is; vasectomy] or congenitally sterile) and their female partners are of childbearing potential, must use, together with their female partners, acceptable birth control methods for the duration of the study and for 6.0 months after discontinuation of the investigational medicinal product (IMP). Additional criteria apply, please contact the investigator for more information. Exclusion Criteria: At the time of screening visit, participant is receiving any preventive migraine medications, regardless of the medical indication for more than 5 days and expects to continue with these medications. Participant has received onabotulinumtoxinA for migraine or for any medical or cosmetic reasons requiring injections in the head, face, or neck during the 3 months before screening visit. The participant has used an intervention/device (for example; scheduled nerve blocks and transcranial magnetic stimulation) for migraine during the 2 months prior to screening. The participant uses triptans/ergots as preventive therapies for migraine. Participant uses non-steroidal anti-inflammatory drugs (NSAIDs) as preventive therapy for migraine on nearly daily basis for other indications. Note: Low dose aspirin (for example; 81 mg) used for cardiovascular disease prevention is allowed. Additional criteria apply, please contact the investigator for more information.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Teva Medical Expert, MD

Organizational Affiliation

Teva Branded Pharmaceutical Products R&D, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Teva Investigational Site 14742

City

Huntsville

State/Province

Alabama

ZIP/Postal Code

35801

Country

United States

Facility Name

Teva Investigational Site 14729

City

Long Beach

State/Province

California

ZIP/Postal Code

90806

Country

United States

Facility Name

Teva Investigational Site 14739

City

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

Facility Name

Teva Investigational Site 14843

City

Santa Monica

State/Province

California

ZIP/Postal Code

90404

Country

United States

Facility Name

Teva Investigational Site 14749

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80918

Country

United States

Facility Name

Teva Investigational Site 14758

City

Maitland

State/Province

Florida

ZIP/Postal Code

32751

Country

United States

Facility Name

Teva Investigational Site 14738

City

Orlando

State/Province

Florida

ZIP/Postal Code

32819

Country

United States

Facility Name

Teva Investigational Site 14760

City

Decatur

State/Province

Georgia

ZIP/Postal Code

30030

Country

United States

Facility Name

Teva Investigational Site 14737

City

Meridian

State/Province

Idaho

ZIP/Postal Code

83642

Country

United States

Facility Name

Teva Investigational Site 14730

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60607

Country

United States

Facility Name

Teva Investigational Site 14740

City

Evanston

State/Province

Illinois

ZIP/Postal Code

60201

Country

United States

Facility Name

Teva Investigational Site 14735

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40223

Country

United States

Facility Name

Teva Investigational Site 14747

City

Pikesville

State/Province

Maryland

ZIP/Postal Code

21208

Country

United States

Facility Name

Teva Investigational Site 14750

City

Fall River

State/Province

Massachusetts

ZIP/Postal Code

02720

Country

United States

Facility Name

Teva Investigational Site 14734

City

Watertown

State/Province

Massachusetts

ZIP/Postal Code

02472

Country

United States

Facility Name

Teva Investigational Site 14731

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48104

Country

United States

Facility Name

Teva Investigational Site 14748

City

Plymouth

State/Province

Minnesota

ZIP/Postal Code

55441

Country

United States

Facility Name

Teva Investigational Site 14746

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68114

Country

United States

Facility Name

Teva Investigational Site 14754

City

Berlin

State/Province

New Jersey

ZIP/Postal Code

08009

Country

United States

Facility Name

Teva Investigational Site 14752

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87102

Country

United States

Facility Name

Teva Investigational Site 14753

City

Amherst

State/Province

New York

ZIP/Postal Code

14226

Country

United States

Facility Name

Teva Investigational Site 14736

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27405

Country

United States

Facility Name

Teva Investigational Site 14741

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27408

Country

United States

Facility Name

Teva Investigational Site 14732

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27607

Country

United States

Facility Name

Teva Investigational Site 14761

City

Lincoln

State/Province

Rhode Island

ZIP/Postal Code

02865

Country

United States

Facility Name

Teva Investigational Site 14756

City

Warwick

State/Province

Rhode Island

ZIP/Postal Code

02886

Country

United States

Facility Name

Teva Investigational Site 14745

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38119

Country

United States

Facility Name

Teva Investigational Site 14743

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

Teva Investigational Site 14733

City

Austin

State/Province

Texas

ZIP/Postal Code

78731

Country

United States

Facility Name

Teva Investigational Site 14751

City

West Jordan

State/Province

Utah

ZIP/Postal Code

84088

Country

United States

Facility Name

Teva Investigational Site 37092

City

Brugge

ZIP/Postal Code

8000

Country

Belgium

Facility Name

Teva Investigational Site 37089

City

Brussels

ZIP/Postal Code

1090

Country

Belgium

Facility Name

Teva Investigational Site 37091

City

Hasselt

ZIP/Postal Code

3500

Country

Belgium

Facility Name

Teva Investigational Site 37090

City

Liege

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Teva Investigational Site 54162

City

Brno

ZIP/Postal Code

602 00

Country

Czechia

Facility Name

Teva Investigational Site 54165

City

Ostrava-Moravska

ZIP/Postal Code

702 00

Country

Czechia

Facility Name

Teva Investigational Site 54159

City

Ostrava

ZIP/Postal Code

70200

Country

Czechia

Facility Name

Teva Investigational Site 54158

City

Pardubice

ZIP/Postal Code

53002

Country

Czechia

Facility Name

Teva Investigational Site 54164

City

Prague 4

ZIP/Postal Code

140 59

Country

Czechia

Facility Name

Teva Investigational Site 54163

City

Prague

ZIP/Postal Code

100 00

Country

Czechia

Facility Name

Teva Investigational Site 54160

City

Praha 10

ZIP/Postal Code

160 00

Country

Czechia

Facility Name

Teva Investigational Site 54161

City

Praha 3

ZIP/Postal Code

130 00

Country

Czechia

Facility Name

Teva Investigational Site 54166

City

Praha 8

ZIP/Postal Code

186 00

Country

Czechia

Facility Name

Teva Investigational Site 54157

City

Rychnov nad Kneznou

ZIP/Postal Code

51601

Country

Czechia

Facility Name

Teva Investigational Site 39051

City

Aalborg

ZIP/Postal Code

9000

Country

Denmark

Facility Name

Teva Investigational Site 39049

City

Arhus

ZIP/Postal Code

8000

Country

Denmark

Facility Name

Teva Investigational Site 39052

City

Ballerup

ZIP/Postal Code

2750

Country

Denmark

Facility Name

Teva Investigational Site 39048

City

Glostrup

ZIP/Postal Code

2600

Country

Denmark

Facility Name

Teva Investigational Site 39050

City

Vejle

ZIP/Postal Code

7100

Country

Denmark

Facility Name

Teva Investigational Site 40034

City

Helsinki

ZIP/Postal Code

00180

Country

Finland

Facility Name

Teva Investigational Site 40035

City

Helsinki

ZIP/Postal Code

00930

Country

Finland

Facility Name

Teva Investigational Site 40036

City

Oulu

ZIP/Postal Code

90100

Country

Finland

Facility Name

Teva Investigational Site 40033

City

Tampere

ZIP/Postal Code

FI-33100

Country

Finland

Facility Name

Teva Investigational Site 40032

City

Turku

ZIP/Postal Code

20100

Country

Finland

Facility Name

Teva Investigational Site 40037

City

Turku

ZIP/Postal Code

20520

Country

Finland

Facility Name

Teva Investigational Site 35237

City

Bron Cedex

ZIP/Postal Code

69677

Country

France

Facility Name

Teva Investigational Site 35238

City

Lille

ZIP/Postal Code

59037

Country

France

Facility Name

Teva Investigational Site 35235

City

Marseille

ZIP/Postal Code

13005

Country

France

Facility Name

Teva Investigational Site 35240

City

Nice

ZIP/Postal Code

06000

Country

France

Facility Name

Teva Investigational Site 35239

City

Strasbourg

ZIP/Postal Code

67098

Country

France

Facility Name

Teva Investigational Site 35236

City

Voiron

ZIP/Postal Code

38500

Country

France

Facility Name

Teva Investigational Site 32697

City

Berlin

ZIP/Postal Code

10177

Country

Germany

Facility Name

Teva Investigational Site 32690

City

Berlin

ZIP/Postal Code

D-10435

Country

Germany

Facility Name

Teva Investigational Site 32694

City

Bochum

ZIP/Postal Code

44787

Country

Germany

Facility Name

Teva Investigational Site 32699

City

Essen

ZIP/Postal Code

45147

Country

Germany

Facility Name

Teva Investigational Site 32692

City

Goppingen

ZIP/Postal Code

73033

Country

Germany

Facility Name

Teva Investigational Site 32691

City

Halle

ZIP/Postal Code

06120

Country

Germany

Facility Name

Teva Investigational Site 32698

City

Hamburg

ZIP/Postal Code

20251

Country

Germany

Facility Name

Teva Investigational Site 32700

City

Kiel

ZIP/Postal Code

24149

Country

Germany

Facility Name

Teva Investigational Site 32695

City

Konigstein im Taunus

ZIP/Postal Code

61462

Country

Germany

Facility Name

Teva Investigational Site 32689

City

Muenchen

ZIP/Postal Code

81377

Country

Germany

Facility Name

Teva Investigational Site 32701

City

Rostock

ZIP/Postal Code

18147

Country

Germany

Facility Name

Teva Investigational Site 32693

City

Ulm

ZIP/Postal Code

89073

Country

Germany

Facility Name

Teva Investigational Site 30199

City

Firenze

ZIP/Postal Code

50134

Country

Italy

Facility Name

Teva Investigational Site 30204

City

Roma

ZIP/Postal Code

00128

Country

Italy

Facility Name

Teva Investigational Site 38126

City

Amsterdam

ZIP/Postal Code

1078VV

Country

Netherlands

Facility Name

Teva Investigational Site 38127

City

Blaricum

ZIP/Postal Code

1261 AN

Country

Netherlands

Facility Name

Teva Investigational Site 38124

City

Leiden

ZIP/Postal Code

2333 ZA

Country

Netherlands

Facility Name

Teva Investigational Site 38125

City

Tilburg

ZIP/Postal Code

5042 AD

Country

Netherlands

Facility Name

Teva Investigational Site 53420

City

Krakow

ZIP/Postal Code

31-209

Country

Poland

Facility Name

Teva Investigational Site 53425

City

Krakow

ZIP/Postal Code

33-332

Country

Poland

Facility Name

Teva Investigational Site 53422

City

Lodz

ZIP/Postal Code

90-338

Country

Poland

Facility Name

Teva Investigational Site 53424

City

Lodz

ZIP/Postal Code

90-368

Country

Poland

Facility Name

Teva Investigational Site 53418

City

Lublin

ZIP/Postal Code

20-022

Country

Poland

Facility Name

Teva Investigational Site 53416

City

Poznan

ZIP/Postal Code

60-529

Country

Poland

Facility Name

Teva Investigational Site 53419

City

Szczecin

ZIP/Postal Code

70-111

Country

Poland

Facility Name

Teva Investigational Site 53417

City

Warszawa

ZIP/Postal Code

00-909

Country

Poland

Facility Name

Teva Investigational Site 53423

City

Warszawa

ZIP/Postal Code

04-730

Country

Poland

Facility Name

Teva Investigational Site 31231

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Teva Investigational Site 31235

City

Madrid

ZIP/Postal Code

28223

Country

Spain

Facility Name

Teva Investigational Site 31236

City

Madrid

ZIP/Postal Code

28942

Country

Spain

Facility Name

Teva Investigational Site 31226

City

Pamplona

ZIP/Postal Code

31008

Country

Spain

Facility Name

Teva Investigational Site 31229

City

Santander

ZIP/Postal Code

39008

Country

Spain

Facility Name

Teva Investigational Site 31230

City

Santiago de Compostela

ZIP/Postal Code

15706

Country

Spain

Facility Name

Teva Investigational Site 31234

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

Teva Investigational Site 31233

City

Valencia

ZIP/Postal Code

46010

Country

Spain

Facility Name

Teva Investigational Site 31227

City

Valencia

ZIP/Postal Code

46026

Country

Spain

Facility Name

Teva Investigational Site 31225

City

Valladolid

ZIP/Postal Code

47003

Country

Spain

Facility Name

Teva Investigational Site 31228

City

Zaragoza

ZIP/Postal Code

50009

Country

Spain

Facility Name

Teva Investigational Site 42050

City

Helsingborg

ZIP/Postal Code

252 20

Country

Sweden

Facility Name

Teva Investigational Site 42049

City

Huddinge

ZIP/Postal Code

141 86

Country

Sweden

Facility Name

Teva Investigational Site 42051

City

Lund

ZIP/Postal Code

260 83

Country

Sweden

Facility Name

Teva Investigational Site 42052

City

Stockholm

ZIP/Postal Code

112 81

Country

Sweden

Facility Name

Teva Investigational Site 42054

City

Stockholm

ZIP/Postal Code

114 33

Country

Sweden

Facility Name

Teva Investigational Site 45018

City

Bad Zurzach

ZIP/Postal Code

5330

Country

Switzerland

Facility Name

Teva Investigational Site 45016

City

Bern

ZIP/Postal Code

3010

Country

Switzerland

Facility Name

Teva Investigational Site 45017

City

Lugano

ZIP/Postal Code

6900

Country

Switzerland

Facility Name

Teva Investigational Site 34231

City

Glasgow

ZIP/Postal Code

G51 4TF

Country

United Kingdom

Facility Name

Teva Investigational Site 34232

City

Hull

ZIP/Postal Code

HU3 2JZ

Country

United Kingdom

Facility Name

Teva Investigational Site 34233

City

London

ZIP/Postal Code

SE5 9NT

Country

United Kingdom

Facility Name

Teva Investigational Site 34230

City

Oxford

ZIP/Postal Code

OX3 9DU

Country

United Kingdom

Facility Name

Teva Investigational Site 34235

City

Salford

ZIP/Postal Code

M6 8HD

Country

United Kingdom

Facility Name

Teva Investigational Site 34236

City

Stoke-on-Trent

ZIP/Postal Code

ST4 6QG

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

36038833

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.

Results Reference

derived

PubMed Identifier

35331009

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.

Results Reference

derived

PubMed Identifier

35302681

Citation

Lampl C, Rapoport AM, Cohen JM, Barash S, Ramirez Campos V, Seminerio MJ, Ning X, Silberstein SD. Efficacy and quality-of-life improvements with fremanezumab treatment in patients with difficult-to-treat migraine with associated neurological dysfunction. Eur J Neurol. 2022 Jul;29(7):2129-2137. doi: 10.1111/ene.15328. Epub 2022 Mar 29.

Results Reference

derived

PubMed Identifier

34922436

Citation

MaassenVanDenBrink A, Terwindt GM, Cohen JM, Barash S, Campos VR, Galic M, Ning X, Karppa M. Impact of age and sex on the efficacy of fremanezumab in patients with difficult-to-treat migraine: results of the randomized, placebo-controlled, phase 3b FOCUS study. J Headache Pain. 2021 Dec 18;22(1):152. doi: 10.1186/s10194-021-01336-1.

Results Reference

derived

PubMed Identifier

34819017

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. Erratum In: J Headache Pain. 2022 May 17;23(1):57.

Results Reference

derived

PubMed Identifier

34246226

Citation

Ashina M, Cohen JM, Galic M, Campos VR, Barash S, Ning X, Kessler Y, Janka L, Diener HC. Efficacy and safety of fremanezumab in patients with episodic and chronic migraine with documented inadequate response to 2 to 4 classes of migraine preventive medications over 6 months of treatment in the phase 3b FOCUS study. J Headache Pain. 2021 Jul 10;22(1):68. doi: 10.1186/s10194-021-01279-7.

Results Reference

derived

PubMed Identifier

33990144

Citation

Pazdera L, Cohen JM, Ning X, Campos VR, Yang R, Pozo-Rosich P. Fremanezumab for the Preventive Treatment of Migraine: Subgroup Analysis by Number of Prior Preventive Treatments with Inadequate Response. Cephalalgia. 2021 Sep;41(10):1075-1088. doi: 10.1177/03331024211008401. Epub 2021 May 14.

Results Reference

derived

PubMed Identifier

33863272

Citation

Spierings ELH, Karppa M, Ning X, Cohen JM, Campos VR, Yang R, Reuter U. Efficacy and safety of fremanezumab in patients with migraine and inadequate response to prior preventive treatment: subgroup analyses by country of a randomized, placebo-controlled trial. J Headache Pain. 2021 Apr 16;22(1):26. doi: 10.1186/s10194-021-01232-8.

Results Reference

derived

PubMed Identifier

31427046

Citation

Ferrari MD, Diener HC, Ning X, Galic M, Cohen JM, Yang R, Mueller M, Ahn AH, Schwartz YC, Grozinski-Wolff M, Janka L, Ashina M. Fremanezumab versus placebo for migraine prevention in patients with documented failure to up to four migraine preventive medication classes (FOCUS): a randomised, double-blind, placebo-controlled, phase 3b trial. Lancet. 2019 Sep 21;394(10203):1030-1040. doi: 10.1016/S0140-6736(19)31946-4. Epub 2019 Aug 16. Erratum In: Lancet. 2019 Oct 29;:

Results Reference

derived

Learn more about this trial

An Efficacy and Safety Study of Fremanezumab in Adults With Migraine

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An Efficacy and Safety Study of Fremanezumab in Adults With Migraine (FOCUS)

Migraine Prophylaxis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial