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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04464707
Other study ID # TV48125-CNS-30082
Secondary ID 2019-002053-33
Status Recruiting
Phase Phase 3
First received
Last updated
Start date July 30, 2020
Est. completion date February 22, 2025

Study information

Verified date February 2024
Source Teva Branded Pharmaceutical Products R&D, Inc.
Contact Teva U.S. Medical Information
Phone 1-888-483-8279
Email USMedInfo@tevapharm.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective of the study is to evaluate the effectiveness of fremanezumab as compared to placebo for the preventive treatment of chronic migraine (CM). Secondary objectives are to further demonstrate the efficacy of Fremanezumab as compared to placebo for the preventive treatment of CM, to evaluate the safety and tolerability of Fremanezumab in the preventive treatment of CM 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 75 months.


Recruitment information / eligibility

Status Recruiting
Enrollment 278
Est. completion date February 22, 2025
Est. primary completion date February 22, 2025
Accepts healthy volunteers No
Gender All
Age group 6 Years to 17 Years
Eligibility 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 =15 headache days per month on average during the 3 months prior to screening (visit 1). - The participant or parent/caregiver maintain a prospectively collected headache diary 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 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, at the discretion of the investigator. Any prior history of a suicide attempt, or a history of suicidal ideation with a specific plan within the past 2 years must be excluded. - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Fremanezumab
Dose A or Dose B subcutaneous
Placebo
Matching placebo

Locations

Country Name City State
Canada Teva Investigational Site 11180 Ajax Ontario
Canada Teva Investigational Site 11181 Montreal Quebec
Canada Teva Investigational Site 11179 Nepean Ontario
Canada Teva Investigational Site 11182 Ottawa Ontario
Finland Teva Investigational Site 40053 Helsinki
Finland Teva Investigational Site 40049 Kuopio
Finland Teva Investigational Site 40054 Oulu
Finland Teva Investigational Site 40052 Tampere
Germany Teva Investigational Site 32728 Bad Homburg
Germany Teva Investigational Site 32729 Berlin
Germany Teva Investigational Site 32725 Dresden
Germany Teva Investigational Site 32724 Essen
Germany Teva Investigational Site 32726 Leipzig
Israel Teva Investigational Site 80170 Be'er Ya'akov
Israel Teva Investigational Site 80166 Haifa
Israel Teva Investigational Site 80168 Holon
Israel Teva Investigational Site 80169 Jerusalem
Israel Teva Investigational Site 80167 Ramat Gan
Israel Teva Investigational Site 80164 Safed
Israel Teva Investigational Site 80165 Tel-Aviv
Italy Teva Investigational Site 30230 Firenze
Italy Teva Investigational Site 30226 Milano
Italy Teva Investigational Site 30228 Milano
Italy Teva Investigational Site 30239 Milano
Italy Teva Investigational Site 30238 Padua
Italy Teva Investigational Site 30227 Pavia
Italy Teva Investigational Site 30225 Rome
Netherlands Teva Investigational Site 38138 Doetinchem
Netherlands Teva Investigational Site 38135 Nijmegen
Netherlands Teva Investigational Site 38136 Rotterdam
Poland Teva Investigational Site 53441 Gdansk
Poland Teva Investigational Site 53437 Kielce
Poland Teva Investigational Site 53443 Krakow
Poland Teva Investigational Site 53452 Krakow
Poland Teva Investigational Site 53440 Lublin
Poland Teva Investigational Site 53439 Poznan
Poland Teva Investigational Site 53451 Poznan
Poland Teva Investigational Site 53442 Szczecin
Spain Teva Investigational Site 31271 Barcelona
Spain Teva Investigational Site 31266 Elda
Spain Teva Investigational Site 31267 Madrid
Spain Teva Investigational Site 31268 Madrid
Spain Teva Investigational Site 31270 Valencia
Spain Teva Investigational Site 31265 Valladolid
United States Teva Investigational Site 14276 Amherst New York
United States Teva Investigational Site 14251 Ann Arbor Michigan
United States Teva Investigational Site 14243 Atlanta Georgia
United States Teva Investigational Site 14319 Aurora Colorado
United States Teva Investigational Site 14252 Austin Texas
United States Teva Investigational Site 14273 Austin Texas
United States Teva Investigational Site 14365 Baltimore Maryland
United States Teva Investigational Site 14253 Banning California
United States Teva Investigational Site 14256 Bridgeton Missouri
United States Teva Investigational Site 14374 Bristol Tennessee
United States Teva Investigational Site 14264 Cincinnati Ohio
United States Teva Investigational Site 14368 Colorado Springs Colorado
United States Teva Investigational Site 14360 Covington Louisiana
United States Teva Investigational Site 14367 Dallas Texas
United States Teva Investigational Site 14377 Durham North Carolina
United States Teva Investigational Site 14263 Hoffman Estates Illinois
United States Teva Investigational Site 14274 Houston Texas
United States Teva Investigational Site 14312 Houston Texas
United States Teva Investigational Site 14244 Jacksonville Florida
United States Teva Investigational Site 14281 Little Rock Arkansas
United States Teva Investigational Site 14370 Loma Linda California
United States Teva Investigational Site 14322 Los Angeles California
United States Teva Investigational Site 14327 Louisville Kentucky
United States Teva Investigational Site 14316 Miami Florida
United States Teva Investigational Site 14325 Miami Florida
United States Teva Investigational Site 14270 Minneapolis Minnesota
United States Teva Investigational Site 14371 New Brunswick New Jersey
United States Teva Investigational Site 14323 Norfolk Virginia
United States Teva Investigational Site 14257 Oklahoma City Oklahoma
United States Teva Investigational Site 14275 Oklahoma City Oklahoma
United States Teva Investigational Site 14283 Park Ridge Illinois
United States Teva Investigational Site 14364 Philadelphia Pennsylvania
United States Teva Investigational Site 14248 Raleigh North Carolina
United States Teva Investigational Site 14376 Ridgeland Mississippi
United States Teva Investigational Site 14361 Sacramento California
United States Teva Investigational Site 14375 Salt Lake City Utah
United States Teva Investigational Site 14241 San Antonio Texas
United States Teva Investigational Site 14366 San Antonio Texas
United States Teva Investigational Site 14258 Savannah Georgia
United States Teva Investigational Site 14317 Silver Spring Maryland
United States Teva Investigational Site 14277 Tacoma Washington
United States Teva Investigational Site 14363 Tulsa Oklahoma
United States Teva Investigational Site 14246 Waltham Massachusetts
United States Teva Investigational Site 14250 West Palm Beach Florida
United States Teva Investigational Site 14255 West Palm Beach Florida
United States Teva Investigational Site 14245 Wichita Kansas

Sponsors (1)

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

Countries where clinical trial is conducted

United States,  Canada,  Finland,  Germany,  Israel,  Italy,  Netherlands,  Poland,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean change in the monthly average number of migraine days after the first dose of study drug Baseline - Month 3
Secondary Number of adverse events including local injection site reaction/pain Baseline - Month 3
Secondary Incidence of abnormal standard 12-lead electrocardiogram (ECG) findings Baseline - Month 3
Secondary Incidence of abnormal vital signs (systolic and diastolic blood pressure, pulse, temperature, and respiratory rate), height, and weight measurements Baseline - Month 3
Secondary Number of participants with clinically significant changes in laboratory values Baseline, Month 1, and Month 3
Secondary Incidence of abnormal physical examination findings Baseline - Month 3
Secondary 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. Screening - Month 3
Secondary Mean change in monthly average number of headache days of at least moderate severity after the first dose of study drug Baseline - Month 3
Secondary Proportion of participants reaching at least 50% reduction in the monthly average number of migraine days after the first dose of study drug Baseline - Month 3
Secondary Mean change in the monthly average number of days of use of any acute headache medications after the first dose of study drug Baseline - Month 3
Secondary 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. Baseline and Month 3
Secondary 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.
Baseline - Month 3
Secondary Proportion 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. Baseline - Month 3
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