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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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