A Study to Test if Fremanezumab is Effective in Preventing Episodic Migraine in Patients 6 to 17 Years of Age

  • STATUS
    Recruiting
  • End date
    Dec 19, 2023
  • participants needed
    288
  • sponsor
    Teva Branded Pharmaceutical Products R&D, Inc.
Updated on 10 October 2021
Investigator
Teva U.S. Medical Information
Primary Contact
Teva Investigational Site 14263 (7.6 mi away) Contact
+69 other location
headache
fremanezumab
daily headaches
episodic migraine
recurrent headaches

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.

Details
Condition Migraine, Primary Stabbing Headache, Migraine (Adult), Migraine and Cluster Headaches, Migraine (Pediatric), migraines
Treatment Placebo, Fremanezumab
Clinical Study IdentifierNCT04458857
SponsorTeva Branded Pharmaceutical Products R&D, Inc.
Last Modified on10 October 2021

Eligibility

Yes No Not Sure

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 migraine 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 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, or taking a combined estrogen and progestogen hormonal contraceptive
NOTE: Additional criteria apply; please contact the investigator for more
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
information
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
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