Back to resultsA Study to Test if Fremanezumab is Effective in Preventing Episodic Migraine in Patients 6 to 17 Years of Age
Primary Purpose
Migraine
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Fremanezumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Migraine focused on measuring episodic migraine
Eligibility Criteria
Inclusion Criteria:
- The participant has a clinical history of recurrent headache consistent with the diagnosis of migraine for at least 6 months before screening, consistent with ICHD-3 criteria (Headache Classification Committee of the IHS 2013), and a history of ≤=14 headache days per month in each of the 3 months prior to screening (visit 1).
- The participant or parent/caregiver maintain a prospectively collected headache diary
- The participant does not have chronic daily headache. For the purposes of this study, chronic daily headache is operationally defined as <4 headache-free days during the 28-day baseline period.
NOTE: Additional criteria apply; please contact the investigator for more information.
Exclusion Criteria:
- The participant is using medications containing opioids (including codeine) or barbiturates (including Fiorinal®, Fioricet®, or any other combination containing butalbital) for the treatment of migraine during the 3 months prior to the day of the screening visit.
- The participant or parent/caregiver maintain a prospectively collected headache diary
- The participant has used an intervention/device (eg, scheduled nerve block or transcranial magnetic stimulation) for the treatment of migraine or in the head or neck area for any condition during the 2 months prior to the day of the screening visit.
- The participant has a current history of a clinically significant psychiatric condition, any prior history of a suicide attempt, or a history of suicidal ideation with a specific plan within the past 2 years, at the discretion of the investigator.
- The participant has an ongoing infection or a known history of human immunodeficiency virus infection, tuberculosis, Lyme disease, or chronic hepatitis B or C, or a known active infection of coronavirus disease 2019 (COVID-19).
- The participant has a past or current history of cancer.
- The participant is pregnant or nursing.
- The participant has a history of hypersensitivity reactions to injected proteins, including mAbs, or a history of Stevens-Johnson Syndrome or toxic epidermal necrolysis syndrome, or the participant is concomitantly using lamotrigine.
- The participant received a live attenuated vaccine (eg, intranasal flu vaccine, and measles, mumps, and rubella vaccine) within the 12-week period prior to screening. Note: If a medical need arises during the study, the participant may receive a live attenuated vaccine.
- The patient has a current or past medical history of hemiplegic migraine.
NOTE: Additional criteria apply; please contact the investigator for more information.
Sites / Locations
- Teva Investigational Site 14281
- Teva Investigational Site 14253
- Teva Investigational Site 14370
- Teva Investigational Site 14322
- Teva Investigational Site 14361
- Teva Investigational Site 14319Recruiting
- Teva Investigational Site 14368Recruiting
- Teva Investigational Site 14244Recruiting
- Teva Investigational Site 14325Recruiting
- Teva Investigational Site 14250Recruiting
- Teva Investigational Site 14255
- Teva Investigational Site 14243
- Teva Investigational Site 14258Recruiting
- Teva Investigational Site 14263Recruiting
- Teva Investigational Site 14283
- Teva Investigational Site 14245Recruiting
- Teva Investigational Site 14327Recruiting
- Teva Investigational Site 14360Recruiting
- Teva Investigational Site 14365Recruiting
- Teva Investigational Site 14317
- Teva Investigational Site 14246Recruiting
- Teva Investigational Site 14251Recruiting
- Teva Investigational Site 14270
- Teva Investigational Site 14376Recruiting
- Teva Investigational Site 14256
- Teva Investigational Site 14371Recruiting
- Teva Investigational Site 14276Recruiting
- Teva Investigational Site 14377Recruiting
- Teva Investigational Site 14248
- Teva Investigational Site 14264Recruiting
- Teva Investigational Site 14257Recruiting
- Teva Investigational Site 14275
- Teva Investigational Site 14363
- Teva Investigational Site 14364Recruiting
- Teva Investigational Site 14374Recruiting
- Teva Investigational Site 14252Recruiting
- Teva Investigational Site 14273
- Teva Investigational Site 14274
- Teva Investigational Site 14367Recruiting
- Teva Investigational Site 14312
- Teva Investigational Site 14366Recruiting
- Teva Investigational Site 14241
- Teva Investigational Site 14375Recruiting
- Teva Investigational Site 14323Recruiting
- Teva Investigational Site 14277Recruiting
- Teva Investigational Site 11180Recruiting
- Teva Investigational Site 11179Recruiting
- Teva Investigational Site 11182Recruiting
- Teva Investigational Site 11181Recruiting
- Teva Investigational Site 40053Recruiting
- Teva Investigational Site 40049Recruiting
- Teva Investigational Site 40054Recruiting
- Teva Investigational Site 40052Recruiting
- Teva Investigational Site 32728Recruiting
- Teva Investigational Site 32729Recruiting
- Teva Investigational Site 32725Recruiting
- Teva Investigational Site 32724
- Teva Investigational Site 32726Recruiting
- Teva Investigational Site 80166Recruiting
- Teva Investigational Site 80168Recruiting
- Teva Investigational Site 80169Recruiting
- Teva Investigational Site 80167Recruiting
- Teva Investigational Site 80164Recruiting
- Teva Investigational Site 80165Recruiting
- Teva Investigational Site 80170Recruiting
- Teva Investigational Site 30230Recruiting
- Teva Investigational Site 30239Recruiting
- Teva Investigational Site 30228Recruiting
- Teva Investigational Site 30226Recruiting
- Teva Investigational Site 30238Recruiting
- Teva Investigational Site 30227Recruiting
- Teva Investigational Site 30225Recruiting
- Teva Investigational Site 38138Recruiting
- Teva Investigational Site 38135Recruiting
- Teva Investigational Site 38136Recruiting
- Teva Investigational Site 53441Recruiting
- Teva Investigational Site 53437Recruiting
- Teva Investigational Site 53443Recruiting
- Teva Investigational Site 53452Recruiting
- Teva Investigational Site 53440Recruiting
- Teva Investigational Site 53439Recruiting
- Teva Investigational Site 53451Recruiting
- Teva Investigational Site 53442Recruiting
- Teva Investigational Site 31271Recruiting
- Teva Investigational Site 31266Recruiting
- Teva Investigational Site 31268
- Teva Investigational Site 31267
- Teva Investigational Site 31270
- Teva Investigational Site 31265Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Fremanezumab
Placebo
Arm Description
Participants weighing ≥ threshold will receive Dose A subcutaneously monthly Participants weighing < threshold will receive Dose B subcutaneously monthly subcutaneously monthly, for 3 months.
Matching placebo
Outcomes
Primary Outcome Measures
Mean change in the monthly average number of migraine days after the first dose of study drug
Secondary Outcome Measures
Mean change in monthly average number of headache days of at least moderate severity after the first dose of study drug
Number of participants reaching at least 50% reduction in the monthly average number of migraine days after the first dose of study drug
Mean change in the monthly average number of days of use of any acute headache medications after the first dose of study drug
Mean change in the PedMIDAS questionnaire after administration of the first dose of study drug
The Pediatric Migraine Disability Assessment (PedMIDAS) is used to assess migraine disability across multiple domains of functioning including school, home, social, and recreational. The measure consists of 6 items measuring the number of days in which activities were missed as a result of headache/migraine. The measure yields a total score by summing items. Total scores correspond to one of four "disability grades:" 0-10 = little to no disability, 11-30 = mild disability, 31-50 = moderate disability, and >50 = severe disability.
Mean change PedsQL after administration of the first dose of study drug
Pediatric Quality of Life Inventory (PedsQL) A health-related quality-of-life instrument that consists of a well-validated generic core measure and some condition and disease-specific modules. The instructions ask how much of a problem each item has been during the past 1 month. A 5-point response scale is utilized across child self-report and parent proxy report as follows:
0=never a problem;
almost never a problem;
sometimes a problem;
often a problem;
almost always a problem.
Number of adverse events
including local injection site reaction/pain
Incidence of abnormal standard 12-lead electrocardiogram (ECG) findings
Incidence of abnormal vital signs
(systolic and diastolic blood pressure, pulse, temperature, and respiratory rate), height, and weight measurements
Number of participants with clinically significant changes in laboratory values
Incidence of abnormal physical examination findings
Yes/No suicidality ideation
Columbia-Suicide Severity Rating Scale (C-SSRS) The C-SSRS is an assessment tool that evaluates suicidal ideation and behavior. Scale range: Yes or No response to 10 questions, with minimum to maximum range of 0 to 10. Lower score represents better outcomes.
Number of participants developing antidrug antibodies (ADAs) throughout the study
The impact of ADAs on safety and efficacy will be analyzed if the number of ADA-positive participants allows.
Full Information
NCT ID
NCT04458857
First Posted
June 22, 2020
Last Updated
October 24, 2023
Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04458857
Brief Title
A Study to Test if Fremanezumab is Effective in Preventing Episodic Migraine in Patients 6 to 17 Years of Age
Official Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy, Safety, and Tolerability of Subcutaneous Administration of Fremanezumab Versus Placebo for the Preventive Treatment of Episodic Migraine in Pediatric Patients 6 to 17 Years of Age
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2020 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)
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
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objective of the study is to evaluate the effectiveness of fremanezumab as compared to placebo for the preventive treatment of episodic migraine (EM).
Secondary objectives are to further demonstrate the efficacy of Fremanezumab as compared to placebo for the preventive treatment of EM, to evaluate the safety and tolerability of Fremanezumab in the preventive treatment of EM and to evaluate the immunogenicity of Fremanezumab and the impact of antidrug antibodies (ADAs) on clinical outcomes in participants exposed to Fremanezumab.
The total duration of the study is planned to be up to 36 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
episodic migraine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
288 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fremanezumab
Arm Type
Experimental
Arm Description
Participants weighing ≥ threshold will receive Dose A subcutaneously monthly Participants weighing < threshold will receive Dose B subcutaneously monthly subcutaneously monthly, for 3 months.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo
Intervention Type
Drug
Intervention Name(s)
Fremanezumab
Intervention Description
Dose A or Dose B subcutaneous
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo
Primary Outcome Measure Information:
Title
Mean change in the monthly average number of migraine days after the first dose of study drug
Time Frame
Baseline - Month 3
Secondary Outcome Measure Information:
Title
Mean change in monthly average number of headache days of at least moderate severity after the first dose of study drug
Time Frame
Baseline - Month 3
Title
Number of participants reaching at least 50% reduction in the monthly average number of migraine days after the first dose of study drug
Time Frame
Baseline - Month 3
Title
Mean change in the monthly average number of days of use of any acute headache medications after the first dose of study drug
Time Frame
Baseline - Month 3
Title
Mean change in the PedMIDAS questionnaire after administration of the first dose of study drug
Description
The Pediatric Migraine Disability Assessment (PedMIDAS) is used to assess migraine disability across multiple domains of functioning including school, home, social, and recreational. The measure consists of 6 items measuring the number of days in which activities were missed as a result of headache/migraine. The measure yields a total score by summing items. Total scores correspond to one of four "disability grades:" 0-10 = little to no disability, 11-30 = mild disability, 31-50 = moderate disability, and >50 = severe disability.
Time Frame
Baseline and Month 3
Title
Mean change PedsQL after administration of the first dose of study drug
Description
Pediatric Quality of Life Inventory (PedsQL) A health-related quality-of-life instrument that consists of a well-validated generic core measure and some condition and disease-specific modules. The instructions ask how much of a problem each item has been during the past 1 month. A 5-point response scale is utilized across child self-report and parent proxy report as follows:
0=never a problem;
almost never a problem;
sometimes a problem;
often a problem;
almost always a problem.
Time Frame
Baseline - Month 3
Title
Number of adverse events
Description
including local injection site reaction/pain
Time Frame
Baseline - Month 3
Title
Incidence of abnormal standard 12-lead electrocardiogram (ECG) findings
Time Frame
Baseline - Month 3
Title
Incidence of abnormal vital signs
Description
(systolic and diastolic blood pressure, pulse, temperature, and respiratory rate), height, and weight measurements
Time Frame
Baseline - Month 3
Title
Number of participants with clinically significant changes in laboratory values
Time Frame
Baseline, Month 1, and Month 3
Title
Incidence of abnormal physical examination findings
Time Frame
Baseline - Month 3
Title
Yes/No suicidality ideation
Description
Columbia-Suicide Severity Rating Scale (C-SSRS) The C-SSRS is an assessment tool that evaluates suicidal ideation and behavior. Scale range: Yes or No response to 10 questions, with minimum to maximum range of 0 to 10. Lower score represents better outcomes.
Time Frame
Screening - Month 3
Title
Number of participants developing antidrug antibodies (ADAs) throughout the study
Description
The impact of ADAs on safety and efficacy will be analyzed if the number of ADA-positive participants allows.
Time Frame
Baseline - Month 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The participant has a clinical history of recurrent headache consistent with the diagnosis of migraine for at least 6 months before screening, consistent with ICHD-3 criteria (Headache Classification Committee of the IHS 2013), and a history of ≤=14 headache days per month in each of the 3 months prior to screening (visit 1).
The participant or parent/caregiver maintain a prospectively collected headache diary
The participant does not have chronic daily headache. For the purposes of this study, chronic daily headache is operationally defined as <4 headache-free days during the 28-day baseline period.
NOTE: Additional criteria apply; please contact the investigator for more information.
Exclusion Criteria:
The participant is using medications containing opioids (including codeine) or barbiturates (including Fiorinal®, Fioricet®, or any other combination containing butalbital) for the treatment of migraine during the 3 months prior to the day of the screening visit.
The participant or parent/caregiver maintain a prospectively collected headache diary
The participant has used an intervention/device (eg, scheduled nerve block or transcranial magnetic stimulation) for the treatment of migraine or in the head or neck area for any condition during the 2 months prior to the day of the screening visit.
The participant has a current history of a clinically significant psychiatric condition, any prior history of a suicide attempt, or a history of suicidal ideation with a specific plan within the past 2 years, at the discretion of the investigator.
The participant has an ongoing infection or a known history of human immunodeficiency virus infection, tuberculosis, Lyme disease, or chronic hepatitis B or C, or a known active infection of coronavirus disease 2019 (COVID-19).
The participant has a past or current history of cancer.
The participant is pregnant or nursing.
The participant has a history of hypersensitivity reactions to injected proteins, including mAbs, or a history of Stevens-Johnson Syndrome or toxic epidermal necrolysis syndrome, or the participant is concomitantly using lamotrigine.
The participant received a live attenuated vaccine (eg, intranasal flu vaccine, and measles, mumps, and rubella vaccine) within the 12-week period prior to screening. Note: If a medical need arises during the study, the participant may receive a live attenuated vaccine.
The patient has a current or past medical history of hemiplegic migraine.
NOTE: Additional criteria apply; please contact the investigator for more information.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Teva U.S. Medical Information
Phone
1-888-483-8279
Email
USMedInfo@tevapharm.com
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 14281
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Individual Site Status
Terminated
Facility Name
Teva Investigational Site 14253
City
Banning
State/Province
California
ZIP/Postal Code
92220
Country
United States
Individual Site Status
Terminated
Facility Name
Teva Investigational Site 14370
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Individual Site Status
Completed
Facility Name
Teva Investigational Site 14322
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Completed
Facility Name
Teva Investigational Site 14361
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States
Individual Site Status
Completed
Facility Name
Teva Investigational Site 14319
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 14368
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 14244
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 14325
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 14250
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 14255
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Individual Site Status
Terminated
Facility Name
Teva Investigational Site 14243
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Individual Site Status
Terminated
Facility Name
Teva Investigational Site 14258
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 14263
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 14283
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Individual Site Status
Completed
Facility Name
Teva Investigational Site 14245
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67206
Country
United States
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 14327
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 14360
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 14365
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 14317
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
26505
Country
United States
Individual Site Status
Terminated
Facility Name
Teva Investigational Site 14246
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02451
Country
United States
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 14251
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 14270
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55402
Country
United States
Individual Site Status
Completed
Facility Name
Teva Investigational Site 14376
City
Ridgeland
State/Province
Mississippi
ZIP/Postal Code
39157
Country
United States
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 14256
City
Bridgeton
State/Province
Missouri
ZIP/Postal Code
63044-2513
Country
United States
Individual Site Status
Completed
Facility Name
Teva Investigational Site 14371
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 14276
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 14377
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 14248
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Individual Site Status
Terminated
Facility Name
Teva Investigational Site 14264
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229-3039
Country
United States
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 14257
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 14275
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73116
Country
United States
Individual Site Status
Completed
Facility Name
Teva Investigational Site 14363
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Individual Site Status
Terminated
Facility Name
Teva Investigational Site 14364
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4318
Country
United States
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 14374
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 14252
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 14273
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Individual Site Status
Completed
Facility Name
Teva Investigational Site 14274
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Individual Site Status
Completed
Facility Name
Teva Investigational Site 14367
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 14312
City
Houston
State/Province
Texas
ZIP/Postal Code
77087
Country
United States
Individual Site Status
Terminated
Facility Name
Teva Investigational Site 14366
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 14241
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Individual Site Status
Completed
Facility Name
Teva Investigational Site 14375
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84109
Country
United States
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 14323
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23510
Country
United States
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 14277
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 11180
City
Ajax
State/Province
Ontario
ZIP/Postal Code
L1Z 0M1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 11179
City
Nepean
State/Province
Ontario
ZIP/Postal Code
K2G 1W2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 11182
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 11181
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 40053
City
Helsinki
ZIP/Postal Code
00380
Country
Finland
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 40049
City
Kuopio
ZIP/Postal Code
70210
Country
Finland
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 40054
City
Oulu
ZIP/Postal Code
90100
Country
Finland
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 40052
City
Tampere
ZIP/Postal Code
33521
Country
Finland
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 32728
City
Bad Homburg
ZIP/Postal Code
61350
Country
Germany
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 32729
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 32725
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 32724
City
Essen
ZIP/Postal Code
45133
Country
Germany
Individual Site Status
Completed
Facility Name
Teva Investigational Site 32726
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 80166
City
Haifa
ZIP/Postal Code
3339419
Country
Israel
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 80168
City
Holon
ZIP/Postal Code
58100
Country
Israel
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 80169
City
Jerusalem
ZIP/Postal Code
9124001
Country
Israel
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 80167
City
Ramat Gan
ZIP/Postal Code
5265601
Country
Israel
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 80164
City
Safed
ZIP/Postal Code
1311001
Country
Israel
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 80165
City
Tel-Aviv
ZIP/Postal Code
6423906
Country
Israel
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 80170
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 30230
City
Firenze
ZIP/Postal Code
50139
Country
Italy
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 30239
City
Milano
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 30228
City
Milano
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 30226
City
Milano
ZIP/Postal Code
20148
Country
Italy
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 30238
City
Padua
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 30227
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 30225
City
Rome
ZIP/Postal Code
00163
Country
Italy
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 38138
City
Doetinchem
ZIP/Postal Code
7009 BL
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 38135
City
Nijmegen
ZIP/Postal Code
6532 SZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 38136
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 53441
City
Gdansk
ZIP/Postal Code
80-389
Country
Poland
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 53437
City
Kielce
ZIP/Postal Code
25-316
Country
Poland
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 53443
City
Krakow
ZIP/Postal Code
30-363
Country
Poland
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 53452
City
Krakow
ZIP/Postal Code
30-539
Country
Poland
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 53440
City
Lublin
ZIP/Postal Code
20-582
Country
Poland
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 53439
City
Poznan
ZIP/Postal Code
60-355
Country
Poland
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 53451
City
Poznan
ZIP/Postal Code
60-848
Country
Poland
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 53442
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 31271
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 31266
City
Elda
ZIP/Postal Code
03600
Country
Spain
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 31268
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Terminated
Facility Name
Teva Investigational Site 31267
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Completed
Facility Name
Teva Investigational Site 31270
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Completed
Facility Name
Teva Investigational Site 31265
City
Valladolid
ZIP/Postal Code
47010
Country
Spain
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request
Learn more about this trial
A Study to Test if Fremanezumab is Effective in Preventing Episodic Migraine in Patients 6 to 17 Years of Age
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