Comparing Efficacy and Safety of 2 Dose Regimens of Subcutaneous Administration of TEV-48125 Versus Placebo for the Preventive Treatment of Chronic Migraine

Migraine Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy and Safety of 2 Dose Regimens of Subcutaneous Administration of Fremanezumab (TEV-48125) Versus Placebo for the Preventive Treatment of Chronic Migraine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02621931
• Other study ID #: TV48125-CNS-30049
• Secondary ID: 2015-004549-23
• Status: Completed
• Phase: Phase 3
• Start date: March 22, 2016
• Est. completion date: April 11, 2017

Study information

• Verified date: November 2021
• Source: Teva Branded Pharmaceutical Products R&D, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is being conducted to evaluate two doses of TEV-48125 in adult patients with chronic migraine

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1130
• Est. completion date: April 11, 2017
• Est. primary completion date: April 11, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Males or females aged 18 to 70 years, inclusive, with migraine onset at =50 years of age

• Patient signs and dates the informed consent document

• Patient has history of migraine according to International Classification of Headache Disorders, or clinical judgment suggests a migraine diagnosis

• 85% e-diary compliance

• Total body weight between 99 and 250 lbs, inclusive

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

Exclusion Criteria:

• Clinically significant hematological, cardiac, renal, endocrine, pulmonary, gastrointestinal, genitourinary, neurologic, hepatic, or ocular disease, at the discretion of the investigator

• Evidence or medical history of clinically significant psychiatric issues, including any suicide attempt in the past, or suicidal ideation with a specific plan in the past 2 years

• History of clinically significant cardiovascular disease or vascular ischemia (such as myocardial, neurological [eg, cerebral ischemia], peripheral extremity ischemia, or other ischemic event) or thromboembolic events (arterial or venous thrombotic or embolic events), such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism

• Known infection or history of human immunodeficiency virus, tuberculosis, or chronic hepatitis B or C infection

• Past or current history of cancer in the last 5 years, except for appropriately treated nonmelanoma skin carcinoma

• Pregnant or nursing females

• History of hypersensitivity reactions to injected proteins, including monoclonal antibodies

• Participation in a clinical study of a new chemical entity or a prescription medicine within 2 months prior to study drug administration or 5 half-lives, whichever is longer

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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• Fremanezumab
Fremanezumab was provided as a sterile, unpreserved, aqueous solution for injection, 225 mg/1.5 mL pre-filled syringe for single-use administration. The 675 mg dose was given as 3 injections; doses of 225 mg were given as a single injection. Study drug was administered at the clinical site.
• Placebo
Placebo 1.5 mL pre-filled syringes identical in appearance to active intervention. Study drug was administered at the clinical site.

Locations

Country	Name	City	State
Canada	Teva Investigational Site 11120	Calgary
Canada	Teva Investigational Site 11120	Calgary
Canada	Teva Investigational Site 11124	Hamilton	Ontario
Canada	Teva Investigational Site 11124	Hamilton	Ontario
Canada	Teva Investigational Site 11121	Montreal
Canada	Teva Investigational Site 11121	Montreal
Canada	Teva Investigational Site 11122	Newmarket
Canada	Teva Investigational Site 11122	Newmarket
Canada	Teva Investigational Site 11123	Sarnia
Canada	Teva Investigational Site 11123	Sarnia
Czechia	Teva Investigational Site 54144	Brno
Czechia	Teva Investigational Site 54144	Brno
Czechia	Teva Investigational Site 54141	Kunratice
Czechia	Teva Investigational Site 54141	Kunratice
Czechia	Teva Investigational Site 54145	Pardubice
Czechia	Teva Investigational Site 54145	Pardubice
Czechia	Teva Investigational Site 54142	Prague 4
Czechia	Teva Investigational Site 54142	Prague 4
Czechia	Teva Investigational Site 54143	Praha
Czechia	Teva Investigational Site 54143	Praha
Czechia	Teva Investigational Site 54146	Praha 3
Czechia	Teva Investigational Site 54146	Praha 3
Finland	Teva Investigational Site 40017	Helsinki
Finland	Teva Investigational Site 40017	Helsinki
Finland	Teva Investigational Site 40018	Helsinki
Finland	Teva Investigational Site 40018	Helsinki
Finland	Teva Investigational Site 40016	Turku
Finland	Teva Investigational Site 40016	Turku
Israel	Teva Investigational Site 80096	Holon
Israel	Teva Investigational Site 80096	Holon
Israel	Teva Investigational Site 80099	Jerusalem
Israel	Teva Investigational Site 80099	Jerusalem
Israel	Teva Investigational Site 80098	Nahariya
Israel	Teva Investigational Site 80097	Netanya
Israel	Teva Investigational Site 80097	Netanya
Israel	Teva Investigational Site 80100	Ramat Gan
Israel	Teva Investigational Site 80100	Ramat Gan
Israel	Teva Investigational Site 80095	Tel Aviv
Japan	Teva Investigational Site 84064	Chofu-shi
Japan	Teva Investigational Site 84072	Chofu-shi
Japan	Teva Investigational Site 84072	Chofu-shi
Japan	Teva Investigational Site 84066	Kagoshima
Japan	Teva Investigational Site 84066	Kagoshima-shi
Japan	Teva Investigational Site 84069	Kai
Japan	Teva Investigational Site 84069	Kai-shi
Japan	Teva Investigational Site 84073	Kawasaki
Japan	Teva Investigational Site 84073	Kawasaki-shi
Japan	Teva Investigational Site 84067	Kyoto
Japan	Teva Investigational Site 84067	Kyoto
Japan	Teva Investigational Site 84062	Osaka-shi
Japan	Teva Investigational Site 84062	Osaka-shi
Japan	Teva Investigational Site 84070	Saitama
Japan	Teva Investigational Site 84070	Saitama-shi
Japan	Teva Investigational Site 84061	Sendai-shi
Japan	Teva Investigational Site 84061	Sendai-shi
Japan	Teva Investigational Site 84065	Shimotsuma
Japan	Teva Investigational Site 84068	Shizuoka
Japan	Teva Investigational Site 84068	Shizuoka-shi
Japan	Teva Investigational Site 84065	Tochigi
Japan	Teva Investigational Site 84064	Tokyo
Japan	Teva Investigational Site 84071	Toyonaka
Japan	Teva Investigational Site 84071	Toyonaka-shi
Poland	Teva Investigational Site 53363	Krakow
Poland	Teva Investigational Site 53363	Krakow
Poland	Teva Investigational Site 53364	Krakow
Poland	Teva Investigational Site 53364	Krakow
Poland	Teva Investigational Site 53366	Lublin
Poland	Teva Investigational Site 53366	Lublin
Poland	Teva Investigational Site 53365	Poznan
Poland	Teva Investigational Site 53365	Poznan
Poland	Teva Investigational Site 53367	Warsaw
Poland	Teva Investigational Site 53367	Warsaw
Russian Federation	Teva Investigational Site 50395	Kazan
Russian Federation	Teva Investigational Site 50395	Kazan
Russian Federation	Teva Investigational Site 50399	Kazan
Russian Federation	Teva Investigational Site 50399	Kazan
Russian Federation	Teva Investigational Site 50394	Moscow
Russian Federation	Teva Investigational Site 50394	Moscow
Russian Federation	Teva Investigational Site 50400	Moscow
Russian Federation	Teva Investigational Site 50400	Moscow
Russian Federation	Teva Investigational Site 50396	Nizhniy Novgorod
Russian Federation	Teva Investigational Site 50396	Nizhniy Novgorod
Russian Federation	Teva Investigational Site 50398	Nizhniy Novgorod
Russian Federation	Teva Investigational Site 50398	Nizhniy Novgorod
Russian Federation	Teva Investigational Site 50397	Ufa
Russian Federation	Teva Investigational Site 50397	Ufa
Spain	Teva Investigational Site 31207	Madrid
Spain	Teva Investigational Site 31207	Madrid
Spain	Teva Investigational Site 31208	Pamplona
Spain	Teva Investigational Site 31208	Pamplona
Spain	Teva Investigational Site 31205	Valladolid
Spain	Teva Investigational Site 31205	Valladolid
Spain	Teva Investigational Site 31206	Zaragoza
Spain	Teva Investigational Site 31206	Zaragoza
United States	Teva Investigational Site 13609	Akron	Ohio
United States	Teva Investigational Site 13609	Akron	Ohio
United States	Teva Investigational Site 13634	Akron	Ohio
United States	Teva Investigational Site 13634	Akron	Ohio
United States	Teva Investigational Site 13588	Albuquerque	New Mexico
United States	Teva Investigational Site 13588	Albuquerque	New Mexico
United States	Teva Investigational Site 13576	Amherst	New York
United States	Teva Investigational Site 13576	Amherst	New York
United States	Teva Investigational Site 13539	Ann Arbor	Michigan
United States	Teva Investigational Site 13539	Ann Arbor	Michigan
United States	Teva Investigational Site 13537	Atlanta	Georgia
United States	Teva Investigational Site 13537	Atlanta	Georgia
United States	Teva Investigational Site 13620	Atlanta	Georgia
United States	Teva Investigational Site 13620	Atlanta	Georgia
United States	Teva Investigational Site 13629	Aurora	Colorado
United States	Teva Investigational Site 13629	Aurora	Colorado
United States	Teva Investigational Site 13541	Austin	Texas
United States	Teva Investigational Site 13541	Austin	Texas
United States	Teva Investigational Site 13582	Baltimore	Maryland
United States	Teva Investigational Site 13577	Birmingham	Alabama
United States	Teva Investigational Site 13577	Birmingham	Alabama
United States	Teva Investigational Site 13628	Birmingham	Alabama
United States	Teva Investigational Site 13628	Birmingham	Alabama
United States	Teva Investigational Site 13604	Boise	Idaho
United States	Teva Investigational Site 13590	Boston	Massachusetts
United States	Teva Investigational Site 13590	Boston	Massachusetts
United States	Teva Investigational Site 13557	Boulder	Colorado
United States	Teva Investigational Site 13557	Boulder	Colorado
United States	Teva Investigational Site 13635	Bradenton	Florida
United States	Teva Investigational Site 13635	Bradenton	Florida
United States	Teva Investigational Site 13560	Bristol	Tennessee
United States	Teva Investigational Site 13560	Bristol	Tennessee
United States	Teva Investigational Site 13585	Chicago	Illinois
United States	Teva Investigational Site 13585	Chicago	Illinois
United States	Teva Investigational Site 13621	Chicago	Illinois
United States	Teva Investigational Site 13621	Chicago	Illinois
United States	Teva Investigational Site 13533	Cincinnati	Ohio
United States	Teva Investigational Site 13533	Cincinnati	Ohio
United States	Teva Investigational Site 13624	Cincinnati	Ohio
United States	Teva Investigational Site 13624	Cincinnati	Ohio
United States	Teva Investigational Site 13569	Cleveland	Ohio
United States	Teva Investigational Site 13569	Cleveland	Ohio
United States	Teva Investigational Site 13593	Colorado Springs	Colorado
United States	Teva Investigational Site 13593	Colorado Springs	Colorado
United States	Teva Investigational Site 13626	Columbus	Ohio
United States	Teva Investigational Site 13626	Columbus	Ohio
United States	Teva Investigational Site 13623	Dallas	Texas
United States	Teva Investigational Site 13623	Dallas	Texas
United States	Teva Investigational Site 13612	Denver	Colorado
United States	Teva Investigational Site 13612	Denver	Colorado
United States	Teva Investigational Site 13633	Denver	Colorado
United States	Teva Investigational Site 13633	Denver	Colorado
United States	Teva Investigational Site 13563	East Hartford	Connecticut
United States	Teva Investigational Site 13563	East Hartford	Connecticut
United States	Teva Investigational Site 13568	Encino	California
United States	Teva Investigational Site 13568	Encino	California
United States	Teva Investigational Site 13631	Englewood	Colorado
United States	Teva Investigational Site 13631	Englewood	Colorado
United States	Teva Investigational Site 13601	Eugene	Oregon
United States	Teva Investigational Site 13601	Eugene	Oregon
United States	Teva Investigational Site 13627	Evanston	Illinois
United States	Teva Investigational Site 13627	Evanston	Illinois
United States	Teva Investigational Site 13618	Fremont	Nebraska
United States	Teva Investigational Site 13618	Fremont	Nebraska
United States	Teva Investigational Site 13546	Fullerton	California
United States	Teva Investigational Site 13546	Fullerton	California
United States	Teva Investigational Site 13597	Gainesville	Florida
United States	Teva Investigational Site 13597	Gainesville	Florida
United States	Teva Investigational Site 13542	Golden Valley	Minnesota
United States	Teva Investigational Site 13542	Golden Valley	Minnesota
United States	Teva Investigational Site 13544	Greensboro	North Carolina
United States	Teva Investigational Site 13544	Greensboro	North Carolina
United States	Teva Investigational Site 13574	Greensboro	North Carolina
United States	Teva Investigational Site 13574	Greensboro	North Carolina
United States	Teva Investigational Site 13615	Greer	South Carolina
United States	Teva Investigational Site 13615	Greer	South Carolina
United States	Teva Investigational Site 13607	Hialeah	Florida
United States	Teva Investigational Site 13607	Hialeah	Florida
United States	Teva Investigational Site 13596	Indianapolis	Indiana
United States	Teva Investigational Site 13596	Indianapolis	Indiana
United States	Teva Investigational Site 13559	Jacksonville	Florida
United States	Teva Investigational Site 13559	Jacksonville	Florida
United States	Teva Investigational Site 13591	Jenkintown	Pennsylvania
United States	Teva Investigational Site 13591	Jenkintown	Pennsylvania
United States	Teva Investigational Site 13534	Kansas City	Missouri
United States	Teva Investigational Site 13534	Kansas City	Missouri
United States	Teva Investigational Site 13605	Las Vegas	Nevada
United States	Teva Investigational Site 13605	Las Vegas	Nevada
United States	Teva Investigational Site 13578	Lebanon	New Hampshire
United States	Teva Investigational Site 13578	Lebanon	New Hampshire
United States	Teva Investigational Site 13602	Little Rock	Arkansas
United States	Teva Investigational Site 13602	Little Rock	Arkansas
United States	Teva Investigational Site 13540	Long Beach	California
United States	Teva Investigational Site 13540	Long Beach	California
United States	Teva Investigational Site 13566	Louisville	Kentucky
United States	Teva Investigational Site 13566	Louisville	Kentucky
United States	Teva Investigational Site 13575	Martinsville	New Jersey
United States	Teva Investigational Site 13604	Meridian	Idaho
United States	Teva Investigational Site 13603	Metairie	Louisiana
United States	Teva Investigational Site 13603	Metairie	Louisiana
United States	Teva Investigational Site 13625	Mogadore	Ohio
United States	Teva Investigational Site 13625	Mogadore	Ohio
United States	Teva Investigational Site 13600	Morgantown	West Virginia
United States	Teva Investigational Site 13600	Morgantown	West Virginia
United States	Teva Investigational Site 13556	Mount Pleasant	South Carolina
United States	Teva Investigational Site 13556	Mount Pleasant	South Carolina
United States	Teva Investigational Site 13614	Murray	Utah
United States	Teva Investigational Site 13614	Murray	Utah
United States	Teva Investigational Site 13532	Nashville	Tennessee
United States	Teva Investigational Site 13532	Nashville	Tennessee
United States	Teva Investigational Site 13552	Nashville	Tennessee
United States	Teva Investigational Site 13552	Nashville	Tennessee
United States	Teva Investigational Site 13589	New Bedford	Massachusetts
United States	Teva Investigational Site 13589	New Bedford	Massachusetts
United States	Teva Investigational Site 13584	Ocala	Florida
United States	Teva Investigational Site 13584	Ocala	Florida
United States	Teva Investigational Site 13561	Oklahoma City	Oklahoma
United States	Teva Investigational Site 13561	Oklahoma City	Oklahoma
United States	Teva Investigational Site 13551	Orlando	Florida
United States	Teva Investigational Site 13555	Orlando	Florida
United States	Teva Investigational Site 13587	Orlando	Florida
United States	Teva Investigational Site 13587	Orlando	Florida
United States	Teva Investigational Site 13599	Orlando	Florida
United States	Teva Investigational Site 13599	Orlando	Florida
United States	Teva Investigational Site 13567	Palm Beach Gardens	Florida
United States	Teva Investigational Site 13567	Palm Beach Gardens	Florida
United States	Teva Investigational Site 13553	Pembroke Pines	Florida
United States	Teva Investigational Site 13553	Pembroke Pines	Florida
United States	Teva Investigational Site 13554	Philadelphia	Pennsylvania
United States	Teva Investigational Site 13554	Philadelphia	Pennsylvania
United States	Teva Investigational Site 13579	Phoenix	Arizona
United States	Teva Investigational Site 13579	Phoenix	Arizona
United States	Teva Investigational Site 13606	Phoenix	Arizona
United States	Teva Investigational Site 13606	Phoenix	Arizona
United States	Teva Investigational Site 13582	Pikesville	Maryland
United States	Teva Investigational Site 13616	Pinellas Park	Florida
United States	Teva Investigational Site 13616	Pinellas Park	Florida
United States	Teva Investigational Site 13565	Plainview	New York
United States	Teva Investigational Site 13565	Plainview	New York
United States	Teva Investigational Site 13611	Plano	Texas
United States	Teva Investigational Site 13611	Plano	Texas
United States	Teva Investigational Site 13545	Raleigh	North Carolina
United States	Teva Investigational Site 13545	Raleigh	North Carolina
United States	Teva Investigational Site 13575	Raritan	New Jersey
United States	Teva Investigational Site 13632	Redlands	California
United States	Teva Investigational Site 13632	Redlands	California
United States	Teva Investigational Site 13571	Redondo Beach	California
United States	Teva Investigational Site 13571	Redondo Beach	California
United States	Teva Investigational Site 13619	Saint Louis	Missouri
United States	Teva Investigational Site 13619	Saint Louis	Missouri
United States	Teva Investigational Site 13572	San Antonio	Texas
United States	Teva Investigational Site 13572	San Antonio	Texas
United States	Teva Investigational Site 13573	San Diego	California
United States	Teva Investigational Site 13573	San Diego	California
United States	Teva Investigational Site 13538	Santa Monica	California
United States	Teva Investigational Site 13538	Santa Monica	California
United States	Teva Investigational Site 13594	Santa Rosa	California
United States	Teva Investigational Site 13594	Santa Rosa	California
United States	Teva Investigational Site 13564	Seattle	Washington
United States	Teva Investigational Site 13564	Seattle	Washington
United States	Teva Investigational Site 13586	Seattle	Washington
United States	Teva Investigational Site 13586	Seattle	Washington
United States	Teva Investigational Site 13536	Springfield	Missouri
United States	Teva Investigational Site 13550	Stamford	Connecticut
United States	Teva Investigational Site 13550	Stamford	Connecticut
United States	Teva Investigational Site 13608	Uniontown	Pennsylvania
United States	Teva Investigational Site 13608	Uniontown	Pennsylvania
United States	Teva Investigational Site 13630	Virginia Beach	Virginia
United States	Teva Investigational Site 13630	Virginia Beach	Virginia
United States	Teva Investigational Site 13595	Walnut Creek	California
United States	Teva Investigational Site 13595	Walnut Creek	California
United States	Teva Investigational Site 13543	Watertown	Massachusetts
United States	Teva Investigational Site 13543	Watertown	Massachusetts
United States	Teva Investigational Site 13581	West Jordan	Utah
United States	Teva Investigational Site 13581	West Jordan	Utah
United States	Teva Investigational Site 13598	Wichita	Kansas
United States	Teva Investigational Site 13598	Wichita	Kansas
United States	Teva Investigational Site 13617	Wichita	Kansas
United States	Teva Investigational Site 13617	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Teva Branded Pharmaceutical Products R&D, Inc.

Countries where clinical trial is conducted

United States,  Canada,  Czechia,  Finland,  Israel,  Japan,  Poland,  Russian Federation,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in the Monthly Average Number of Headache Days of At Least Moderate Severity During the 12-Week Period After the First Dose of Study Drug	Headaches were subjectively rated by participants as mild, moderate or severe. A headache day of at least moderate severity was defined as a calendar day (00:00 to 23:59) where the patient (using the electronic headache diary device) reports: - a day with headache pain that lasts =4 hours with a peak severity of at least moderate severity or - a day when the patient used acute migraine-specific medication (triptans or ergots) to treat a headache of any severity or duration. Monthly averages are derived and normalized to 28 days equivalent by the following formula: (# days of efficacy variable over relevant period / # days with assessments recorded in the e-diary over the relevant period) * 28. The change is calculated as post-baseline value - baseline value.	Baseline (Days -28 to Day -1), Treatment (Days 1 - Week 12)
Primary	Participants With Treatment-Emergent Adverse Events (TEAEs)	An adverse event (AE) was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents usual activities. Relationship of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.	Day 1 to Week 12
Secondary	Change From Baseline in the Monthly Average Number of Migraine Days During the 12-Week Period After the First Dose of Study Drug	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 endorsing criteria for migraine with or without aura - a calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours of a headache endorsing criteria for probable migraine, a migraine subtype where only 1 migraine criterion is 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 are derived and normalized to 28 days equivalent by the following formula: (# days of efficacy variable over relevant period / # days with assessments recorded in the e-diary over the relevant period) * 28. The change is calculated as post-baseline value - baseline value.	Baseline (Days -28 to Day -1), Treatment (Days 1 - Week 12)
Secondary	Percentage of Participants With At Least 50% Reduction In Monthly Average Number of Headache Days of At Least Moderate Severity	Responder rates were defined as the percentage of total subjects who reached at least a 50% reduction in the monthly average of headache days (as subjectively reported by participants in the study diary) of at least moderate severity relative to the baseline period. For the overall analysis (Month 1-3), patients who discontinued early were considered non-responders. Monthly averages are derived and normalized to 28 days equivalent by the following formula: (# days of efficacy variable over relevant period / # days with assessments recorded in the e-diary over the relevant period) * 28. The percentage reduction in monthly average is calculated as: ((baseline value - post-baseline value) / baseline value) * 100.	Baseline (Days -28 to Day -1), Treatment: Month 1, Month 2, Month 3, Month 1-3 (Days 1 - Week 12)
Secondary	Change From Baseline in the Monthly Average Number of Days of Use of Any Acute Headache Medicine During the 12 Week Period After the First Dose of Study Drug	Participants recorded any migraine medications (name of drug, number of tablets/capsules, and the dose in milligrams per tablet/capsule) taken on each day in their electronic headache diary device. Acute migraine-specific medication included triptans or ergots. Monthly averages are derived and normalized to 28 days equivalent by the following formula: (# days of efficacy variable over relevant period / # days with assessments recorded in the e-diary over the relevant period) * 28. The change is calculated as post-baseline value - baseline value.	Baseline (Days -28 to Day -1), Treatment (Days 1 - Week 12)
Secondary	Change From Baseline in the Number of Headache Days of At Least Moderate Severity During the 4 Week Period After the First Dose of Study Drug	Headaches were subjectively rated by participants as mild, moderate or severe. A headache day of at least moderate severity was defined as a calendar day (00:00 to 23:59) where the patient (using the electronic headache diary device) reports: - a day with headache pain that lasts =4 hours with a peak severity of at least moderate severity or - a day when the patient used acute migraine-specific medication (triptans or ergots) to treat a headache of any severity or duration. The change is calculated as post-baseline value - baseline value.	Baseline (Days -28 to Day -1), Treatment (Days 1 - Week 4)
Secondary	Change From Baseline in the Monthly Average Number of Headache Days of At Least Moderate Severity During the 12 Week Period After the First Dose of Study Medication in Patients Not Receiving Concomitant Preventive Migraine Medications	A subset of patients (specified in the protocol not to exceed 30%) were allowed to use 1 concomitant migraine preventive medication. This outcome only includes those participants who did not take concomitant preventive migraine medication during this study. Headaches were subjectively rated by participants as mild, moderate or severe. A headache day of >= moderate severity was defined as a calendar day where the patient (using the electronic headache diary device) reports: - a day with headache pain that lasts =4 hours with a peak severity of >= moderate severity or - a day when the patient used acute migraine-specific medication (triptans or ergots) to treat a headache of any severity or duration. Monthly averages are derived and normalized to 28 days equivalent by the following formula: (# days of efficacy variable over relevant period / # days with assessments recorded in the e-diary over the relevant period) * 28. Change is post-baseline value - baseline value.	Baseline (Days -28 to Day -1), Treatment (Days 1 - Week 12)
Secondary	Change From Baseline in Migraine-Related Disability Score, As Measured by the 6-Item Headache Impact Test (HIT) At Week 12	The HIT-6 was developed by Kosinski et al (2003) as a short form for reliably assessing the adverse headache impact in clinical practice and clinical research settings. The questionnaire measures the adverse impact of headache on social functioning, role functioning, vitality, cognitive functioning, and psychological distress. It also assesses headache severity. Scores range from 36 to 78, where a higher score indicates a greater impact of headache on the daily life of the patient, i.e. scores =49 represent little or no impact, scores between 50 and 55 represent some impact, scores between 56 and 59 represent substantial impact; and scores =60 indicate severe impact. Negative change from baseline values indicate less adverse impact of headache.	Baseline, 12 weeks
Secondary	Electrocardiogram (ECG) Findings Shifts From Baseline to Overall	12-lead ECGs were performed before other assessments (eg, blood draws and administration of questionnaires) and performed in triplicate. The worst post-baseline finding for the participant is summarized. Only participants with both baseline and post-baseline ECGs are included. The ECG was evaluated by the investigator at the time of recording (signed and dated), and the printout was kept in the source documentation file. When potentially clinically significant findings were detected by the investigator, a cardiologist at a central diagnostic center was consulted for a definitive interpretation. Any ECG finding that was judged by the investigator as a potentially clinically significant change (worsening) compared with a baseline value was considered an adverse event. - NCS = abnormal, not clinically significant. - CS= abnormal, clinically significant. Shift format is: baseline finding / worst post-baseline finding.	Baseline (Day 0), Treatment Week 12 (or endpoint)
Secondary	Participants With Vital Signs Potentially Clinically Significant Abnormal Values	Vital signs were performed before other assessments (eg, blood draws and administration of questionnaires). Vital signs with potentially clinically significant abnormal findings included: - Pulse Rate High: >=120 and increase of >=15 beats per minute - Pulse Rate Low: <=50 and decrease of >=15 beats per minute - Systolic Blood Pressure Low: <=90 mmHg and decrease of >=20 mmHg - Diastolic Blood Pressure High: >=105 mmHg and increase of >=15 mmHg - Diastolic Blood Pressure Low: <=50 mmHg and decrease of >=15 mmHg - Respiratory Rate Low: <10 breaths / minute	Treatment Days 28, 56 and 84 (or endpoint). Changes from previous reading may reflect the baseline reading performed on Day 0.
Secondary	Participants With Serum Chemistry and Hematology Potentially Clinically Significant Abnormal Results	Serum chemistry and hematology laboratory tests with potentially clinically significant abnormal findings included: - Blood Urea Nitrogen (BUN) High: >=10.71 mmol/L - Creatinine High: >=177 umol/L - Bilirubin High: >=34.2 umol/L - Alanine Aminotransferase (ALT): >=3*upper limit of normal (ULN) - Aspartate Aminotransferase (AST): >=3*upper limit of normal (ULN) - Gamma Glutamyl Transferase (GGT): >=3*upper limit of normal (ULN) - Hemoglobin: Male: <115 g/L or Female: <=95 g/L - Hematocrit: Male: <0.37 L/L or Female: <0.32 L/L - Leukocytes: >=20*10^9/L or <=3*10^9/L - Eosinophils/Leukocytes: >=10% - Platelets: >=700*10^9/L or <=75*10^9/L	Treatment Days 28, 56 and 84 (or endpoint)
Secondary	Participants With Urinalysis Laboratory Tests Potentially Clinically Significant Abnormal Results	Urinalysis with potentially clinically significant abnormal findings included: - Blood: >=2 unit increase from baseline - Urine Glucose (mg/dL): >=2 unit increase from baseline - Ketones (mg/dL): >=2 unit increase from baseline - Urine Protein (mg/dL): >=2 unit increase from baseline	Treatment Days 28, 56 and 84 (or endpoint). Changes from previous reading reflect the baseline reading performed on Day 0.
Secondary	Prothrombin Time Shifts From Baseline to Endpoint	Shifts in prothrombin time from baseline to endpoint were summarized using patient 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) Shift format is: baseline finding / endpoint finding	Baseline (Day 0), Treatment Endpoint (Week 12)
Secondary	Injection Site Reaction Adverse Events	Counts of participants who reported treatment-emergent injection site reactions as AEs are summarized. Preferred terms from MedDRA version 18.1 are offered without a threshold applied.	Day 1 to Week 12
Secondary	Participants With Positive Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) Results After the First Dose of Study Drug	The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) was used to assess the participant's suicidal ideation (severity and intensity) and behavior (Posner et al 2011). Suicidal behavior is 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 is defined as a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation.; The eC-SSRS Baseline/Screening version was completed by the participant at baseline, and the eC-SSRS Since Last Visit version was completed by the participant at all other time points. Any positive findings on the eC-SSRS Since Last Visit version required evaluation by a physician or doctoral-level psychologist. Findings after the first dose of study drug using the eC-SSRS Since Last Visit version are summarized.	Baseline (Day 0), Treatment Days 28, 56, 84