A Phase 3 interventional study of Fremanezumab and Placebo in Migraine, sponsored by Teva Branded Pharmaceutical Products R&D, Inc.. Completed at 89 sites in 9 countries. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-06-22.
Sponsored by Teva Branded Pharmaceutical Products R&D, Inc. (part of Teva Pharmaceutical Industries, Ltd.) · Phase 3, Interventional, and Treatment
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.
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
This study's enrollment of 235 is above the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Teva Branded Pharmaceutical Products R&D, Inc. is the lead sponsor of 206 studies on the registry; none are open to participants now.
Of its 49 completed or terminated interventional studies of FDA-regulated products, 47 (96%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
NOTE: Additional criteria apply; please contact the investigator for more information.
Exclusion Criteria:
NOTE: Additional criteria apply; please contact the investigator for more information.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants weighing \<threshold weight will receive fremanezumab SC at dose A for 3 months.
Drug: Fremanezumab
Participants weighing ≥threshold weight will receive fremanezumab SC at dose B for 3 months.
Drug: Fremanezumab
Matching placebo
Drug: Placebo
Dose A or Dose B subcutaneous
Matching placebo
Mean Change From Baseline in Monthly Average Number of Migraine Days During 12-Week Period After the First Dose of Study Drug
A migraine day was defined as a day with any of the following: A day (0:00 to 23:59) with at least 2 hours of headache with ≥2 migraine symptom(s) or day (0:00 to 23:59) demonstrating a headache treated with migraine medications (e.g., non-steroidal anti-inflammatory drugs \[NSAIDs\], paracetamol etc.), or a headache associated with aura. Monthly averages were derived and normalized to 28 days equivalent by formula: (number of days of efficacy variable over 12-week period/number of days with assessments recorded in electronic diary (e-diary) for 12-week period) \* 28. Least square (LS) mean was calculated using analysis of covariance (ANCOVA). The full analysis set (FAS) included all randomized participants who received at least 1 dose of study drug and had at least 10 days of diary entries postbaseline for efficacy assessments on primary endpoint. Efficacy analysis was planned to be collected and evaluated combined for both fremanezumab dose treatment groups.
Time frame: Baseline (Day -28 to Day -1), up to Week 12
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious AEs (SAEs) were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. AEs were considered TEAEs if onset occurred on or after the first dose date. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Time frame: Baseline up to Month 3
Number of Participants With Shift From Baseline to Last Assessment in Electrocardiogram (ECG) Findings (Assessed by Investigator)
The number of participants with a shift from Baseline (Normal, Abnormal CS \[Clinically Significant\], or Abnormal NCS \[Not Clinically Significant\]) in any of the following ECG parameters is reported by treatment group: Heart rate, PR interval, QRS interval, RR interval, QT interval, QT interval corrected using the Bazett's formula (QTcB), and QT interval corrected using the Fridericia formula (QTcF). Last assessment was defined as the last observed postbaseline interpretation. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Time frame: Baseline to last assessment (up to Month 3)
Number of Participants With Shift From Baseline to Last Assessment in ECG Findings (Assessed by Cardiologist)
The number of participants with a shift from Baseline (Normal or Abnormal) in any of the following ECG parameters is reported by treatment group: Heart rate, PR interval, QRS interval, RR interval, QT interval, QTcB, and QTcF. Last assessment was defined as the last observed postbaseline interpretation. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Time frame: Baseline to last assessment (up to Month 3)
Number of Participants With Any One or More Potentially Clinically Significant Vital Signs Abnormalities
Potentially clinically significant abnormal vital signs findings included any one of the following: Pulse rate ≥120 beats per minute (bpm) and increase from baseline of ≥15 bpm, or ≤50 bpm and decrease from baseline of ≥15 bpm; Systolic blood pressure ≤85 millimeters of mercury (mmHg) and decrease from baseline of ≥20 mmHg; Diastolic blood pressure ≥100 mmHg and increase from baseline of ≥15 mmHg; Respiratory rate \<15 breaths/minute. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Time frame: Baseline up to Month 3
Number of Participants With Potentially Clinically Significant Abnormal Laboratory (Serum Chemistry, Hematology, Coagulation, and Urinalysis) Results
Serum chemistry tests with potentially clinically significant abnormal findings included: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) both ≥2\*upper limit of normal (ULN); and bilirubin ≥34.2 micromole/liter (umol/L). Hematology tests with potentially clinically significant abnormal findings included: hemoglobin ≤100 grams (g)/L, leukocytes ≤3\*10\^9 cells/L, neutrophils ≤1\*10\^9 cells/L, eosinophils/leukocytes ≥10%, and platelets ≥700\*10\^9 cells/L or ≤75\*10\^9 cells/L. Coagulation parameter test with potentially clinically significant abnormal findings included: prothrombin international normalized ratio (INR) \>1.5. Urinalysis laboratory tests with potentially clinically significant abnormal findings included: urine protein ≥2 units (U) increase from baseline. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Time frame: Baseline up to Month 3
Number of Participants With Abnormal Physical Examination Findings as Identified by the Investigator
A complete physical examination included the following organ systems: general appearance; head, eyes, ears, nose, and throat (HEENT); chest and lungs; heart; abdomen; musculoskeletal; skin; lymph nodes; and neurological. Only the organ systems with abnormal physical findings in at least one treatment group have been reported. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Time frame: Baseline up to Month 3
Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
C-SSRS is a questionnaire to assess suicidal ideation and suicidal behavior. Suicidal behavior was defined as a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation was defined as a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent, any self-injurious behavior with no suicidal intent.
Time frame: Baseline and Month 3
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
A headache day of at least moderate severity was defined as a calendar day (00:00 to 23:59) where the participant reported either of the following: A day with headache pain that lasted ≥2 hours with a peak severity of at least moderate severity or a day where the participant used acute medication (triptans, ergots, NSAIDs or paracetamol) to treat a headache of any severity or duration. Monthly averages were derived and normalized to 28 days equivalent by formula: (number of days of efficacy variable over 12-week period/number of days with assessments recorded in e-diary for 12-week period) \* 28. LS mean was calculated using ANCOVA.
Time frame: Baseline (Day -28 to Day -1), up to Week 12
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
A migraine day was defined as a calendar day where the participant reported either of the following: A calendar day (0:00 to 23:59) demonstrating at least 2 consecutive hours of a headache that was accompanied by ≥1 migraine symptom(s) or a calendar day (0:00 to 23:59) demonstrating a headache of any duration that was treated with migraine specific medications (NSAIDs, paracetamol or triptans and ergot compounds). Monthly averages were derived and normalized to 28 days equivalent by formula: (number of days of efficacy variable over 12-week period/number of days with assessments recorded in e-diary for 12-week period) \* 28.
Time frame: Baseline (Day -28 to Day -1) up to Week 12
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
Participants recorded any headache medications (name of drug, number of tablets/capsules, and the dose in milligrams per tablet/capsule) taken each day in their electronic headache diary device. Acute headache medication included triptans and ergot compounds, NSAIDs or paracetamol. Monthly averages were derived and normalized to 28 days equivalent by formula: (number of days of efficacy variable over 12-week period/number of days with assessments recorded in e-diary for 12-week period) \* 28. LS mean was calculated using ANCOVA.
Time frame: Baseline (Day -28 to Day -1), up to Week 12
Mean Change From Baseline in Migraine-related Disability Score at Week 12, as Measured by the Pediatric Migraine Disability Assessment (PedMIDAS) Questionnaire
The PedMIDAS is a scale developed to assess headache-related disability which can be self-administered by the participant or administered by a caregiver. It has been validated in participants aged 4 to 18 years and includes 3 subscales: the impact of headache on school performance (range of scores 0-92), disability at home (range of scores 0-92), social/sport functioning (range of scores 0-92). The subscales are added to get the total score with a range 0 to 276. The total score was used for grading of disability, with 4 score categories of 0 to 10, 11 to 30, 31 to 50, and 51-276 interpreted as disability grades 1 (little or no disability), 2 (mild disability), 3 (moderate disability), and 4 (severe disability), respectively. Higher total scores indicated severe disability. LS mean was calculated using ANCOVA. The change from baseline score is reported with a range of -276 to 276 with higher scores indicating more severe disability.
Time frame: Baseline, Week 12
Mean Change From Baseline in Quality of Life at Week 12, as Measured by Pediatric Quality of Life Inventory (PedsQL) Questionnaire
PedsQL 4.0 is a brief 23-item health-related quality of life (QoL) instrument that evaluates QoL in 4 areas of functioning: physical, emotional, social, and school functioning. For child and adolescent self-report (8 - 18 years) and parent report forms, respondents used a 5-point Likert scale to rate item severity (0=never a problem;1=almost never a problem; 2=sometimes a problem; 3=often a problem; 4=almost always a problem). For younger children (5 - 7 years), a simplified 3-point Likert scale, anchored with a happy and a sad face, was used (0=not at all a problem; 2=sometimes a problem; 4=a lot of a problem). PedsQL yields a total QoL score and 2 summary scores: Physical Health Summary Score and Psychosocial Health Summary Score. To obtain scores, items were reverse scored, transformed to a 0 through 100 scale (0=100, 1=75, 2=50, 3=25, 4=0), and averaged; total scores near 0 indicated lower QoL, while scores approaching 100 indicated higher QoL. LS mean was calculated using ANCOVA.
Time frame: Baseline, Week 12
Number of Participants Developing Anti-drug Antibodies (ADAs) Throughout the Study
Number of participants who developed ADAs were reported.
Time frame: Baseline up to Month 3
| Milestone | Placebo | Fremanezumab Dose A | Fremanezumab Dose B |
|---|---|---|---|
| Started | 112 | 36 | 87 |
| Received at least 1 dose of study drug | 112 | 36 | 87 |
| Completed | 106 | 33 | 86 |
| Not completed | 6 | 3 | 1 |
| Withdrew: Adverse event | 0 | 1 | 0 |
| Withdrew: Withdrawal by subject | 2 | 0 | 0 |
| Withdrew: Withdrawal by parent/guardian | 0 | 0 | 1 |
| Withdrew: Non-compliance with study drug | 0 | 1 | 0 |
| Withdrew: Lost to follow-up | 4 | 1 | 0 |
A migraine day was defined as a day with any of the following: A day (0:00 to 23:59) with at least 2 hours of headache with ≥2 migraine symptom(s) or day (0:00 to 23:59) demonstrating a headache treated with migraine medications (e.g., non-steroidal anti-inflammatory drugs \[NSAIDs\], paracetamol etc.), or a headache associated with aura. Monthly averages were derived and normalized to 28 days equivalent by formula: (number of days of efficacy variable over 12-week period/number of days with assessments recorded in electronic diary (e-diary) for 12-week period) \* 28. Least square (LS) mean was calculated using analysis of covariance (ANCOVA). The full analysis set (FAS) included all randomized participants who received at least 1 dose of study drug and had at least 10 days of diary entries postbaseline for efficacy assessments on primary endpoint. Efficacy analysis was planned to be collected and evaluated combined for both fremanezumab dose treatment groups.
| days/month | Placebo | Fremanezumab |
|---|---|---|
| Mean Change From Baseline in Monthly Average Number of Migraine Days During 12-Week Period After the First Dose of Study Drug | -1.4 ± 0.39 | -2.5 ± 0.38 |
An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious AEs (SAEs) were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. AEs were considered TEAEs if onset occurred on or after the first dose date. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
| Participants | Placebo | Fremanezumab Dose A | Fremanezumab Dose B |
|---|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 55 | 20 | 48 |
The number of participants with a shift from Baseline (Normal, Abnormal CS \[Clinically Significant\], or Abnormal NCS \[Not Clinically Significant\]) in any of the following ECG parameters is reported by treatment group: Heart rate, PR interval, QRS interval, RR interval, QT interval, QT interval corrected using the Bazett's formula (QTcB), and QT interval corrected using the Fridericia formula (QTcF). Last assessment was defined as the last observed postbaseline interpretation. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
| Participants | Placebo | Fremanezumab Dose A | Fremanezumab Dose B |
|---|---|---|---|
| Normal/Normal | 92 | 32 | 74 |
| Abnormal NCS/Normal | 13 | 0 | 4 |
| Abnormal CS/Normal | 0 | 0 | 0 |
| Normal/Abnormal NCS | 2 | 2 | 6 |
| Abnormal NCS/Abnormal NCS | 4 | 1 | 3 |
| Abnormal CS/Abnormal NCS | 0 | 0 | 0 |
| Normal/Abnormal CS | 0 | 0 | 0 |
| Abnormal NCS/Abnormal CS | 0 | 0 | 0 |
| Abnormal CS/Abnormal CS | 0 | 0 | 0 |
| Missing | 1 | 1 | 0 |
The number of participants with a shift from Baseline (Normal or Abnormal) in any of the following ECG parameters is reported by treatment group: Heart rate, PR interval, QRS interval, RR interval, QT interval, QTcB, and QTcF. Last assessment was defined as the last observed postbaseline interpretation. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
| Participants | Placebo | Fremanezumab Dose A | Fremanezumab Dose B |
|---|---|---|---|
| Normal/Normal | 88 | 29 | 72 |
| Abnormal/Normal | 14 | 0 | 5 |
| Normal/Abnormal | 2 | 4 | 4 |
| Abnormal/Abnormal | 6 | 2 | 6 |
| Missing | 2 | 1 | 0 |
Potentially clinically significant abnormal vital signs findings included any one of the following: Pulse rate ≥120 beats per minute (bpm) and increase from baseline of ≥15 bpm, or ≤50 bpm and decrease from baseline of ≥15 bpm; Systolic blood pressure ≤85 millimeters of mercury (mmHg) and decrease from baseline of ≥20 mmHg; Diastolic blood pressure ≥100 mmHg and increase from baseline of ≥15 mmHg; Respiratory rate \<15 breaths/minute. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
| Participants | Placebo | Fremanezumab Dose A | Fremanezumab Dose B |
|---|---|---|---|
| Number of Participants With Any One or More Potentially Clinically Significant Vital Signs Abnormalities | 14 | 3 | 5 |
Serum chemistry tests with potentially clinically significant abnormal findings included: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) both ≥2\*upper limit of normal (ULN); and bilirubin ≥34.2 micromole/liter (umol/L). Hematology tests with potentially clinically significant abnormal findings included: hemoglobin ≤100 grams (g)/L, leukocytes ≤3\*10\^9 cells/L, neutrophils ≤1\*10\^9 cells/L, eosinophils/leukocytes ≥10%, and platelets ≥700\*10\^9 cells/L or ≤75\*10\^9 cells/L. Coagulation parameter test with potentially clinically significant abnormal findings included: prothrombin international normalized ratio (INR) \>1.5. Urinalysis laboratory tests with potentially clinically significant abnormal findings included: urine protein ≥2 units (U) increase from baseline. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
| Participants | Placebo | Fremanezumab Dose A | Fremanezumab Dose B |
|---|---|---|---|
| With at least 1 serum chemistry abnormality | 2 | 1 | 3 |
| With at least 1 hematology abnormality | 6 | 2 | 3 |
| With at least 1 coagulation abnormality | 3 | 0 | 1 |
| With at least 1 urinalysis abnormality | 1 | 0 | 0 |
A complete physical examination included the following organ systems: general appearance; head, eyes, ears, nose, and throat (HEENT); chest and lungs; heart; abdomen; musculoskeletal; skin; lymph nodes; and neurological. Only the organ systems with abnormal physical findings in at least one treatment group have been reported. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
| Participants | Placebo | Fremanezumab Dose A | Fremanezumab Dose B |
|---|---|---|---|
| General Appearance | 0 | 0 | 1 |
| HEENT | 1 | 0 | 1 |
| Musculoskeletal | 2 | 0 | 1 |
| Skin | 5 | 1 | 2 |
| Neurological | 1 | 0 | 0 |
| Extremities/Back | 0 | 0 | 1 |
C-SSRS is a questionnaire to assess suicidal ideation and suicidal behavior. Suicidal behavior was defined as a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation was defined as a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent, any self-injurious behavior with no suicidal intent.
| Participants | Placebo | Fremanezumab Dose A | Fremanezumab Dose B |
|---|---|---|---|
| Baseline | 0 | 1 | 0 |
| Month 3 | 1 | 0 | 0 |
A headache day of at least moderate severity was defined as a calendar day (00:00 to 23:59) where the participant reported either of the following: A day with headache pain that lasted ≥2 hours with a peak severity of at least moderate severity or a day where the participant used acute medication (triptans, ergots, NSAIDs or paracetamol) to treat a headache of any severity or duration. Monthly averages were derived and normalized to 28 days equivalent by formula: (number of days of efficacy variable over 12-week period/number of days with assessments recorded in e-diary for 12-week period) \* 28. LS mean was calculated using ANCOVA.
| days/month | Placebo | Fremanezumab |
|---|---|---|
| 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 ± 0.42 | -2.6 ± 0.40 |
A migraine day was defined as a calendar day where the participant reported either of the following: A calendar day (0:00 to 23:59) demonstrating at least 2 consecutive hours of a headache that was accompanied by ≥1 migraine symptom(s) or a calendar day (0:00 to 23:59) demonstrating a headache of any duration that was treated with migraine specific medications (NSAIDs, paracetamol or triptans and ergot compounds). Monthly averages were derived and normalized to 28 days equivalent by formula: (number of days of efficacy variable over 12-week period/number of days with assessments recorded in e-diary for 12-week period) \* 28.
| Participants | Placebo | Fremanezumab |
|---|---|---|
| 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 |
Participants recorded any headache medications (name of drug, number of tablets/capsules, and the dose in milligrams per tablet/capsule) taken each day in their electronic headache diary device. Acute headache medication included triptans and ergot compounds, NSAIDs or paracetamol. Monthly averages were derived and normalized to 28 days equivalent by formula: (number of days of efficacy variable over 12-week period/number of days with assessments recorded in e-diary for 12-week period) \* 28. LS mean was calculated using ANCOVA.
| days/month | Placebo | Fremanezumab |
|---|---|---|
| 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 ± 0.30 | -2.1 ± 0.29 |
The PedMIDAS is a scale developed to assess headache-related disability which can be self-administered by the participant or administered by a caregiver. It has been validated in participants aged 4 to 18 years and includes 3 subscales: the impact of headache on school performance (range of scores 0-92), disability at home (range of scores 0-92), social/sport functioning (range of scores 0-92). The subscales are added to get the total score with a range 0 to 276. The total score was used for grading of disability, with 4 score categories of 0 to 10, 11 to 30, 31 to 50, and 51-276 interpreted as disability grades 1 (little or no disability), 2 (mild disability), 3 (moderate disability), and 4 (severe disability), respectively. Higher total scores indicated severe disability. LS mean was calculated using ANCOVA. The change from baseline score is reported with a range of -276 to 276 with higher scores indicating more severe disability.
| units on a scale | Placebo | Fremanezumab |
|---|---|---|
| Mean Change From Baseline in Migraine-related Disability Score at Week 12, as Measured by the Pediatric Migraine Disability Assessment (PedMIDAS) Questionnaire | -15.3 ± 3.37 | -21.6 ± 3.29 |
PedsQL 4.0 is a brief 23-item health-related quality of life (QoL) instrument that evaluates QoL in 4 areas of functioning: physical, emotional, social, and school functioning. For child and adolescent self-report (8 - 18 years) and parent report forms, respondents used a 5-point Likert scale to rate item severity (0=never a problem;1=almost never a problem; 2=sometimes a problem; 3=often a problem; 4=almost always a problem). For younger children (5 - 7 years), a simplified 3-point Likert scale, anchored with a happy and a sad face, was used (0=not at all a problem; 2=sometimes a problem; 4=a lot of a problem). PedsQL yields a total QoL score and 2 summary scores: Physical Health Summary Score and Psychosocial Health Summary Score. To obtain scores, items were reverse scored, transformed to a 0 through 100 scale (0=100, 1=75, 2=50, 3=25, 4=0), and averaged; total scores near 0 indicated lower QoL, while scores approaching 100 indicated higher QoL. LS mean was calculated using ANCOVA.
| units on a scale | Placebo | Fremanezumab |
|---|---|---|
| Child-Physical Health Summary Score | 8.3 ± 1.61 | 7.8 ± 1.57 |
| Child-Psychosocial Health Summary Score | 5.3 ± 1.38 | 4.7 ± 1.35 |
| Child-Total Scale Score | 6.2 ± 1.37 | 5.7 ± 1.33 |
| Parent-Physical Health Summary Score | 7.3 ± 2.69 | 7.3 ± 2.35 |
| Parent-Psychosocial Health Summary Score | 6.8 ± 2.28 | 4.3 ± 1.96 |
| Parent-Total Scale Score | 7.2 ± 2.28 | 5.2 ± 1.97 |
Number of participants who developed ADAs were reported.
| Participants | Fremanezumab Dose A | Fremanezumab Dose B |
|---|---|---|
| Number of Participants Developing Anti-drug Antibodies (ADAs) Throughout the Study | 1 | 1 |
Collected over Baseline up to Month 3. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/112 (0%) | 3/112 (2.7%) | 26/112 (23.2%) |
| Fremanezumab Dose A | 0/36 (0%) | 1/36 (2.8%) | 8/36 (22.2%) |
| Fremanezumab Dose B | 0/87 (0%) | 1/87 (1.1%) | 29/87 (33.3%) |
| Event | Placebo | Fremanezumab Dose A | Fremanezumab Dose B |
|---|---|---|---|
| MigraineNervous system disorders | 1/112 | 1/36 | 0/87 |
| Hepatitis infectious mononucleosisInfections and infestations | 0/112 | 0/36 | 1/87 |
| Immune thrombocytopeniaBlood and lymphatic system disorders | 1/112 | 0/36 | 0/87 |
| HemiparesisNervous system disorders | 1/112 | 0/36 | 0/87 |
| Event | Placebo | Fremanezumab Dose A | Fremanezumab Dose B |
|---|---|---|---|
| Injection site erythemaGeneral disorders | 6/112 | 1/36 | 11/87 |
| NasopharyngitisInfections and infestations | 8/112 | 3/36 | 8/87 |
| Injection site painGeneral disorders | 6/112 | 0/36 | 6/87 |
| Injection site swellingGeneral disorders | 1/112 | 1/36 | 5/87 |
| COVID-19Infections and infestations | 6/112 | 2/36 | 5/87 |
| DizzinessNervous system disorders | 0/112 | 0/36 | 5/87 |
| Vaccination site painGeneral disorders | 1/112 | 2/36 | 0/87 |
| Upper respiratory tract infectionInfections and infestations | 5/112 | 2/36 | 4/87 |
| HeadacheNervous system disorders | 2/112 | 2/36 | 0/87 |
The intent-to-treat (ITT) analysis set included all randomized participants.
| Age, Continuous(years) | Placebo | Fremanezumab Dose A | Fremanezumab Dose B | Total |
|---|---|---|---|---|
| Mean | 13.4 ± 2.99 | 11.0 ± 2.27 | 14.2 ± 2.34 | 13.3 ± 2.86 |
| Sex: Female, Male(Participants) | Placebo | Fremanezumab Dose A | Fremanezumab Dose B | Total |
|---|---|---|---|---|
| Female | 64 | 16 | 50 | 130 |
| Male | 48 | 20 | 37 | 105 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | Fremanezumab Dose A | Fremanezumab Dose B | Total |
|---|---|---|---|---|
| Hispanic or Latino | 9 | 4 | 8 | 21 |
| Not Hispanic or Latino | 102 | 31 | 75 | 208 |
| Unknown or Not Reported | 1 | 1 | 4 | 6 |
| Race (NIH/OMB)(Participants) | Placebo | Fremanezumab Dose A | Fremanezumab Dose B | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 2 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 4 | 1 | 4 | 9 |
| White | 84 | 28 | 68 | 180 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 24 | 7 | 13 | 44 |
| Number of Migraine Days Per Month(migraine days per month) | Placebo | Fremanezumab Dose A | Fremanezumab Dose B | Total |
|---|---|---|---|---|
| Mean | 7.5 ± 2.84 | 7.6 ± 2.92 | 7.9 ± 3.21 | 7.7 ± 2.99 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — 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
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Fremanezumab
Teva Branded Pharmaceutical Products R&D, Inc. →