Status:
COMPLETED
A Study to Test if Fremanezumab is Effective in Preventing Episodic Migraine in Patients 6 to 17 Years of Age
Lead Sponsor:
Teva Branded Pharmaceutical Products R&D, Inc.
Conditions:
Migraine
Eligibility:
All Genders
6-17 years
Phase:
PHASE3
Brief Summary
The primary objective of the study is to evaluate the efficacy of fremanezumab as compared to placebo for the preventive treatment of episodic migraine (EM). Secondary objectives are to further demon...
Eligibility Criteria
Inclusion
- 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
- 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, 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 participant has a current or past medical history of hemiplegic migraine.
- NOTE: Additional criteria apply; please contact the investigator for more information.
Key Trial Info
Start Date :
July 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 13 2024
Estimated Enrollment :
235 Patients enrolled
Trial Details
Trial ID
NCT04458857
Start Date
July 15 2020
End Date
March 13 2024
Last Update
June 22 2025
Active Locations (89)
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1
Teva Investigational Site 14281
Little Rock, Arkansas, United States, 72202
2
Teva Investigational Site 14253
Banning, California, United States, 92220
3
Teva Investigational Site 14370
Loma Linda, California, United States, 92354
4
Teva Investigational Site 14322
Los Angeles, California, United States, 90027