Phase 3 N=235 Randomized Quadruple-blind Treatment

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

Migraine

Bottom Line

View on ClinicalTrials.gov: NCT04458857 ↗

Enrolled (actual)

235

Serious AEs

2.1%

Results posted

Apr 2025

Primary outcome: Primary: Mean Change From Baseline in Monthly Average Number of Migraine Days During 12-Week Period After the First Dose of Study Drug — -1.4; -2.5 days/month — p=0.0210

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Fremanezumab (Drug); Placebo (Drug)
Age: Pediatric · 6+ yrs
Sex: All
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Primary completion: Mar 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Change From Baseline in Monthly Average Number of Migraine Days During 12-Week Period After the First Dose of Study Drug	-1.4; -2.5	0.0210 sig
SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	55; 20; 48	—
SECONDARY Number of Participants With Shift From Baseline to Last Assessment in Electrocardiogram (ECG) Findings (Assessed by Investigator)	92; 32; 74; 13; 0; 4	—
SECONDARY Number of Participants With Shift From Baseline to Last Assessment in ECG Findings (Assessed by Cardiologist)	88; 29; 72; 14; 0; 5	—
SECONDARY Number of Participants With Any One or More Potentially Clinically Significant Vital Signs Abnormalities	14; 3; 5	—
SECONDARY Number of Participants With Potentially Clinically Significant Abnormal Laboratory (Serum Chemistry, Hematology, Coagulation, and Urinalysis) Results	2; 1; 3; 6; 2; 3	—
SECONDARY Number of Participants With Abnormal Physical Examination Findings as Identified by the Investigator	0; 0; 1; 1; 0; 1	—
SECONDARY Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)	0; 1; 0; 1; 0; 0	—
SECONDARY Mean Change From Baseline in Monthly Average Number of Headache Days of at Least Moderate Severity During 12-Week Period After the First Dose of Study Drug	-1.5; -2.6	—
SECONDARY Number of Participants Reaching at Least 50% Reduction in the Monthly Average Number of Migraine Days During the 12-week Period After the First Dose of Study Drug	30; 58	—
SECONDARY Mean Change From Baseline in Monthly Average Number of Days of Use of Any Acute Headache Medications During 12-Week Period After the First Dose of Study Drug	-1.0; -2.1	—
SECONDARY Mean Change From Baseline in Migraine-related Disability Score at Week 12, as Measured by the Pediatric Migraine Disability Assessment (PedMIDAS) Questionnaire	-15.3; -21.6	—
SECONDARY Mean Change From Baseline in Quality of Life at Week 12, as Measured by Pediatric Quality of Life Inventory (PedsQL) Questionnaire	8.3; 7.8; 5.3; 4.7; 6.2; 5.7	—
SECONDARY Number of Participants Developing Anti-drug Antibodies (ADAs) Throughout the Study	1; 1	—

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 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 51 months.

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, 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04458857). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.