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

Primary Purpose

Migraine

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Fremanezumab

Placebo

About this trial

This is an interventional treatment trial for Migraine

Eligibility Criteria

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

Inclusion Criteria:

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.
1. Participants must simultaneously use 2 forms of highly effective contraception methods.
2. 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.
- Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

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:
1. mentally or legally incapacitated or unable to give consent for any reason.
2. in custody due to an administrative or a legal decision, under guardianship, or institutionalized.
3. unable to be contacted in case of emergency.
4. has any other condition, which, in the opinion of the investigator, makes the participant inappropriate for inclusion in the study.
Participant is a study center or sponsor employee who is directly involved in the study or the relative of such an employee.
- Additional criteria apply, please contact the investigator for more information.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

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

TEV-48125 225 mg Monthly: Active Rollover Participants

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

TEV-48125 675 mg Quarterly: Active Rollover Participants

Arm Description

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).

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).

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).

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).

Outcomes

Primary Outcome Measures

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.

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.

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.

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.

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.

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.

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.

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02638103

First Posted

December 18, 2015

Last Updated

November 6, 2021

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02638103

Brief Title

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

Acronym

HALO

Official Title

A Multicenter, Randomized, Double-Blind, Parallel-Group Study Evaluating the Long-Term Safety, Tolerability, and Efficacy of Subcutaneous Administration of Fremanezumab (TEV-48125) for the Preventive Treatment of Migraine

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

February 26, 2016 (Actual)

Primary Completion Date

June 6, 2018 (Actual)

Study Completion Date

December 8, 2018 (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

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.

6. Conditions and Keywords

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

Migraine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1890 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

Arm Title

TEV-48125 225 mg Monthly: Active Rollover Participants

Arm Type

Experimental

Arm Description

Arm Title

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

Arm Type

Experimental

Arm Description

Arm Title

TEV-48125 675 mg Quarterly: Active Rollover Participants

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Fremanezumab

Other Intervention Name(s)

TEV-48125

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of Participants With Adverse Events (AEs)

Description

Time Frame

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

Title

Number of Participants With Potentially Clinically Significant Abnormal Serum Chemistry Results

Description

Time Frame

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

Title

Number of Participants With Potentially Clinically Significant Abnormal Hematology Results

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

Number of Participants With Potentially Clinically Significant Abnormal Vital Signs Values

Description

Time Frame

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

Title

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

Description

Time Frame

Baseline (Day 0), endpoint (Day 336)

Title

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

Description

Time Frame

Baseline (Day 0), endpoint (Day 336)

Title

Number of Participants With Injection Site Reactions

Description

Time Frame

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

Title

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

Description

Time Frame

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

Other Pre-specified Outcome Measures:

Title

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

Description

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 (for CM participants) or at least 2 consecutive hours (for EM participants) 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 (for CM participants) or at least 2 consecutive hours (for EM participants) 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.

Time Frame

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

Title

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

Description

Headaches were subjectively rated by participants as mild, moderate or severe. A headache day of any severity for both CM and EM participants was defined as a calendar day (00:00 to 23:59) where the participant (using the electronic headache diary device) reports: a day with headache pain that lasts at least 4 hours with a peak severity of any severity or; a day when the participant used acute migraine-specific medication (triptans or ergots) to treat a headache of any severity or duration. 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.

Time Frame

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

Title

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

Description

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 (for CM participants) or at least 2 consecutive hours (for EM participants) 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 (for CM participants) or at least 2 consecutive hours (for EM participants) 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.

Time Frame

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

Title

Percentage of Participants With At Least 50% Reduction From Baseline in Monthly Average Number of Headache Days of at Least Moderate Severity During the 4-Week Period

Description

Headaches were subjectively rated by participants as mild, moderate or severe. A headache day of at least moderate severity for both CM and EM participants was defined as a calendar day (00:00 to 23:59) where the participant (using the electronic headache diary device) reports: a day with headache pain that lasts at least 4 hours with a peak severity of at least moderate severity or; a day when the participant used acute migraine-specific medication (triptans or ergots) to treat a headache of any severity or duration. 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.

Time Frame

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

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: 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. Additional criteria apply, please contact the investigator for more information Exclusion Criteria: 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. in custody due to an administrative or a legal decision, under guardianship, or institutionalized. unable to be contacted in case of emergency. has any other condition, which, in the opinion of the investigator, makes the participant inappropriate for inclusion in the study. Participant is a study center or sponsor employee who is directly involved in the study or the relative of such an employee. 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 13628

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35211

Country

United States

Facility Name

Teva Investigational Site 13577

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35216

Country

United States

Facility Name

Teva Investigational Site 13606

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85018

Country

United States

Facility Name

Teva Investigational Site 13579

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85023

Country

United States

Facility Name

Teva Investigational Site 13602

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

Teva Investigational Site 13568

City

Encino

State/Province

California

ZIP/Postal Code

91316

Country

United States

Facility Name

Teva Investigational Site 13546

City

Fullerton

State/Province

California

ZIP/Postal Code

92835

Country

United States

Facility Name

Teva Investigational Site 13540

City

Long Beach

State/Province

California

ZIP/Postal Code

90806

Country

United States

Facility Name

Teva Investigational Site 13632

City

Redlands

State/Province

California

ZIP/Postal Code

92374

Country

United States

Facility Name

Teva Investigational Site 13571

City

Redondo Beach

State/Province

California

ZIP/Postal Code

90277

Country

United States

Facility Name

Teva Investigational Site 13573

City

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

Facility Name

Teva Investigational Site 13538

City

Santa Monica

State/Province

California

ZIP/Postal Code

90404

Country

United States

Facility Name

Teva Investigational Site 13594

City

Santa Rosa

State/Province

California

ZIP/Postal Code

95405

Country

United States

Facility Name

Teva Investigational Site 13595

City

Walnut Creek

State/Province

California

ZIP/Postal Code

94598

Country

United States

Facility Name

Teva Investigational Site 13629

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80014

Country

United States

Facility Name

Teva Investigational Site 13557

City

Boulder

State/Province

Colorado

ZIP/Postal Code

80301

Country

United States

Facility Name

Teva Investigational Site 13593

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80918

Country

United States

Facility Name

Teva Investigational Site 13633

City

Denver

State/Province

Colorado

ZIP/Postal Code

80210

Country

United States

Facility Name

Teva Investigational Site 13612

City

Denver

State/Province

Colorado

ZIP/Postal Code

80239

Country

United States

Facility Name

Teva Investigational Site 13631

City

Englewood

State/Province

Colorado

ZIP/Postal Code

80113

Country

United States

Facility Name

Teva Investigational Site 13563

City

East Hartford

State/Province

Connecticut

ZIP/Postal Code

06118

Country

United States

Facility Name

Teva Investigational Site 13550

City

Stamford

State/Province

Connecticut

ZIP/Postal Code

06905

Country

United States

Facility Name

Teva Investigational Site 13635

City

Bradenton

State/Province

Florida

ZIP/Postal Code

34201

Country

United States

Facility Name

Teva Investigational Site 13597

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32607

Country

United States

Facility Name

Teva Investigational Site 13607

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33012

Country

United States

Facility Name

Teva Investigational Site 13559

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32205

Country

United States

Facility Name

Teva Investigational Site 13584

City

Ocala

State/Province

Florida

ZIP/Postal Code

34471

Country

United States

Facility Name

Teva Investigational Site 13587

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Teva Investigational Site 13567

City

Palm Beach Gardens

State/Province

Florida

ZIP/Postal Code

33410

Country

United States

Facility Name

Teva Investigational Site 13553

City

Pembroke Pines

State/Province

Florida

ZIP/Postal Code

33026

Country

United States

Facility Name

Teva Investigational Site 13616

City

Pinellas Park

State/Province

Florida

ZIP/Postal Code

33781

Country

United States

Facility Name

Teva Investigational Site 13620

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30312

Country

United States

Facility Name

Teva Investigational Site 13537

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

Teva Investigational Site 13604

City

Boise

State/Province

Idaho

ZIP/Postal Code

83642

Country

United States

Facility Name

Teva Investigational Site 13585

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60607

Country

United States

Facility Name

Teva Investigational Site 13621

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60654

Country

United States

Facility Name

Teva Investigational Site 13627

City

Evanston

State/Province

Illinois

ZIP/Postal Code

60201

Country

United States

Facility Name

Teva Investigational Site 13596

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46254

Country

United States

Facility Name

Teva Investigational Site 13617

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67207

Country

United States

Facility Name

Teva Investigational Site 13598

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67211

Country

United States

Facility Name

Teva Investigational Site 13566

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40207

Country

United States

Facility Name

Teva Investigational Site 13603

City

Metairie

State/Province

Louisiana

ZIP/Postal Code

70006

Country

United States

Facility Name

Teva Investigational Site 13582

City

Pikesville

State/Province

Maryland

ZIP/Postal Code

21208

Country

United States

Facility Name

Teva Investigational Site 13590

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02131

Country

United States

Facility Name

Teva Investigational Site 13589

City

New Bedford

State/Province

Massachusetts

ZIP/Postal Code

02301

Country

United States

Facility Name

Teva Investigational Site 13543

City

Watertown

State/Province

Massachusetts

ZIP/Postal Code

02472

Country

United States

Facility Name

Teva Investigational Site 13539

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48104

Country

United States

Facility Name

Teva Investigational Site 13542

City

Golden Valley

State/Province

Minnesota

ZIP/Postal Code

55422

Country

United States

Facility Name

Teva Investigational Site 13534

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64114

Country

United States

Facility Name

Teva Investigational Site 13619

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Teva Investigational Site 13536

City

Springfield

State/Province

Missouri

ZIP/Postal Code

65807

Country

United States

Facility Name

Teva Investigational Site 13618

City

Fremont

State/Province

Nebraska

ZIP/Postal Code

68025

Country

United States

Facility Name

Teva Investigational Site 13605

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89106

Country

United States

Facility Name

Teva Investigational Site 13578

City

Lebanon

State/Province

New Hampshire

ZIP/Postal Code

03756

Country

United States

Facility Name

Teva Investigational Site 13575

City

Martinsville

State/Province

New Jersey

ZIP/Postal Code

08836

Country

United States

Facility Name

Teva Investigational Site 13622

City

Princeton

State/Province

New Jersey

ZIP/Postal Code

08540

Country

United States

Facility Name

Teva Investigational Site 13588

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87102

Country

United States

Facility Name

Teva Investigational Site 13576

City

Amherst

State/Province

New York

ZIP/Postal Code

14226

Country

United States

Facility Name

Teva Investigational Site 13565

City

Plainview

State/Province

New York

ZIP/Postal Code

11803

Country

United States

Facility Name

Teva Investigational Site 13544

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27405

Country

United States

Facility Name

Teva Investigational Site 13574

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27408

Country

United States

Facility Name

Teva Investigational Site 13545

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27612

Country

United States

Facility Name

Teva Investigational Site 13609

City

Akron

State/Province

Ohio

ZIP/Postal Code

44311

Country

United States

Facility Name

Teva Investigational Site 13625

City

Akron

State/Province

Ohio

ZIP/Postal Code

44311

Country

United States

Facility Name

Teva Investigational Site 13634

City

Akron

State/Province

Ohio

ZIP/Postal Code

44311

Country

United States

Facility Name

Teva Investigational Site 13533

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45227

Country

United States

Facility Name

Teva Investigational Site 13624

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45249

Country

United States

Facility Name

Teva Investigational Site 13569

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Facility Name

Teva Investigational Site 13626

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43212

Country

United States

Facility Name

Teva Investigational Site 13561

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73112

Country

United States

Facility Name

Teva Investigational Site 13601

City

Eugene

State/Province

Oregon

ZIP/Postal Code

97401

Country

United States

Facility Name

Teva Investigational Site 13591

City

Jenkintown

State/Province

Pennsylvania

ZIP/Postal Code

19046

Country

United States

Facility Name

Teva Investigational Site 13554

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Facility Name

Teva Investigational Site 13608

City

Uniontown

State/Province

Pennsylvania

ZIP/Postal Code

15401

Country

United States

Facility Name

Teva Investigational Site 13615

City

Greer

State/Province

South Carolina

ZIP/Postal Code

29650

Country

United States

Facility Name

Teva Investigational Site 13556

City

Mount Pleasant

State/Province

South Carolina

ZIP/Postal Code

29464

Country

United States

Facility Name

Teva Investigational Site 13560

City

Bristol

State/Province

Tennessee

ZIP/Postal Code

37620

Country

United States

Facility Name

Teva Investigational Site 13551

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38119

Country

United States

Facility Name

Teva Investigational Site 13532

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

Teva Investigational Site 13552

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

Teva Investigational Site 13541

City

Austin

State/Province

Texas

ZIP/Postal Code

78731

Country

United States

Facility Name

Teva Investigational Site 13623

City

Dallas

State/Province

Texas

ZIP/Postal Code

75214

Country

United States

Facility Name

Teva Investigational Site 13611

City

Plano

State/Province

Texas

ZIP/Postal Code

75024

Country

United States

Facility Name

Teva Investigational Site 13572

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Teva Investigational Site 13614

City

Murray

State/Province

Utah

ZIP/Postal Code

84107

Country

United States

Facility Name

Teva Investigational Site 13581

City

West Jordan

State/Province

Utah

ZIP/Postal Code

84088

Country

United States

Facility Name

Teva Investigational Site 13630

City

Virginia Beach

State/Province

Virginia

ZIP/Postal Code

23454

Country

United States

Facility Name

Teva Investigational Site 13564

City

Seattle

State/Province

Washington

ZIP/Postal Code

98105

Country

United States

Facility Name

Teva Investigational Site 13586

City

Seattle

State/Province

Washington

ZIP/Postal Code

98105

Country

United States

Facility Name

Teva Investigational Site 13600

City

Morgantown

State/Province

West Virginia

ZIP/Postal Code

26506

Country

United States

Facility Name

Teva Investigational Site 11124

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 1Y2

Country

Canada

Facility Name

Teva Investigational Site 11122

City

Newmarket

State/Province

Ontario

ZIP/Postal Code

L3Y5G8

Country

Canada

Facility Name

Teva Investigational Site 11120

City

Calgary

ZIP/Postal Code

T3M 1M4

Country

Canada

Facility Name

Teva Investigational Site 11121

City

Montreal

ZIP/Postal Code

H2W 1V1

Country

Canada

Facility Name

Teva Investigational Site 11123

City

Sarnia

ZIP/Postal Code

N7T 4X3

Country

Canada

Facility Name

Teva Investigational Site 54144

City

Brno

ZIP/Postal Code

602 00

Country

Czechia

Facility Name

Teva Investigational Site 54141

City

Kunratice

ZIP/Postal Code

14800

Country

Czechia

Facility Name

Teva Investigational Site 54145

City

Pardubice

ZIP/Postal Code

53002

Country

Czechia

Facility Name

Teva Investigational Site 54142

City

Prague 4

ZIP/Postal Code

140 59

Country

Czechia

Facility Name

Teva Investigational Site 54146

City

Praha 3

ZIP/Postal Code

130 00

Country

Czechia

Facility Name

Teva Investigational Site 54143

City

Praha

ZIP/Postal Code

100 00

Country

Czechia

Facility Name

Teva Investigational Site 40018

City

Helsinki

ZIP/Postal Code

00180

Country

Finland

Facility Name

Teva Investigational Site 40017

City

Helsinki

ZIP/Postal Code

00930

Country

Finland

Facility Name

Teva Investigational Site 40016

City

Turku

ZIP/Postal Code

20100

Country

Finland

Facility Name

Teva Investigational Site 80096

City

Holon

ZIP/Postal Code

58100

Country

Israel

Facility Name

Teva Investigational Site 80099

City

Jerusalem

ZIP/Postal Code

9112001

Country

Israel

Facility Name

Teva Investigational Site 80098

City

Nahariya

ZIP/Postal Code

221001

Country

Israel

Facility Name

Teva Investigational Site 80097

City

Netanya

ZIP/Postal Code

4244916

Country

Israel

Facility Name

Teva Investigational Site 80100

City

Ramat Gan

ZIP/Postal Code

5265601

Country

Israel

Facility Name

Teva Investigational Site 80095

City

Tel Aviv

ZIP/Postal Code

6423906

Country

Israel

Facility Name

Teva Investigational Site 84072

City

Chofu-shi

ZIP/Postal Code

182-0006

Country

Japan

Facility Name

Teva Investigational Site 84066

City

Kagoshima-shi

ZIP/Postal Code

892-0844

Country

Japan

Facility Name

Teva Investigational Site 84069

City

Kai

ZIP/Postal Code

400-0124

Country

Japan

Facility Name

Teva Investigational Site 84073

City

Kawasaki

ZIP/Postal Code

211-8588

Country

Japan

Facility Name

Teva Investigational Site 84067

City

Kyoto

ZIP/Postal Code

600-8811

Country

Japan

Facility Name

Teva Investigational Site 84062

City

Osaka-shi

ZIP/Postal Code

556-0015

Country

Japan

Facility Name

Teva Investigational Site 84070

City

Saitama

ZIP/Postal Code

338-8577

Country

Japan

Facility Name

Teva Investigational Site 84061

City

Sendai-shi

ZIP/Postal Code

982-0014

Country

Japan

Facility Name

Teva Investigational Site 84063

City

Shinjuku-ku

ZIP/Postal Code

160-8582

Country

Japan

Facility Name

Teva Investigational Site 84068

City

Shizuoka

ZIP/Postal Code

4200-853

Country

Japan

Facility Name

Teva Investigational Site 84065

City

Tochigi

ZIP/Postal Code

321-0293

Country

Japan

Facility Name

Teva Investigational Site 84064

City

Tokyo

ZIP/Postal Code

182-0006

Country

Japan

Facility Name

Teva Investigational Site 84071

City

Toyonaka

Country

Japan

Facility Name

Teva Investigational Site 53364

City

Krakow

ZIP/Postal Code

31-523

Country

Poland

Facility Name

Teva Investigational Site 53363

City

Krakow

ZIP/Postal Code

33-332

Country

Poland

Facility Name

Teva Investigational Site 53366

City

Lublin

ZIP/Postal Code

20-022

Country

Poland

Facility Name

Teva Investigational Site 53365

City

Poznan

ZIP/Postal Code

60-529

Country

Poland

Facility Name

Teva Investigational Site 53367

City

Warsaw

ZIP/Postal Code

04-730

Country

Poland

Facility Name

Teva Investigational Site 50399

City

Kazan

ZIP/Postal Code

420012

Country

Russian Federation

Facility Name

Teva Investigational Site 50395

City

Kazan

ZIP/Postal Code

420021

Country

Russian Federation

Facility Name

Teva Investigational Site 50394

City

Moscow

ZIP/Postal Code

121467

Country

Russian Federation

Facility Name

Teva Investigational Site 50400

City

Moscow

ZIP/Postal Code

129128

Country

Russian Federation

Facility Name

Teva Investigational Site 50398

City

Nizhniy Novgorod

ZIP/Postal Code

603126

Country

Russian Federation

Facility Name

Teva Investigational Site 50396

City

Nizhniy Novgorod

ZIP/Postal Code

603137

Country

Russian Federation

Facility Name

Teva Investigational Site 50397

City

Ufa

ZIP/Postal Code

450007

Country

Russian Federation

Facility Name

Teva Investigational Site 31207

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Teva Investigational Site 31208

City

Pamplona

ZIP/Postal Code

31008

Country

Spain

Facility Name

Teva Investigational Site 31205

City

Valladolid

ZIP/Postal Code

47003

Country

Spain

Facility Name

Teva Investigational Site 31206

City

Zaragoza

ZIP/Postal Code

50009

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

32913018

Citation

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.

Results Reference

derived

PubMed Identifier

32887548

Citation

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.

Results Reference

derived

Learn more about this trial

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

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

Migraine

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

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