A Phase 3 interventional study of Fremanezumab and Placebo in Migraine, sponsored by Teva Branded Pharmaceutical Products R&D, Inc.. Completed at 29 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-11-26.
Sponsored by Teva Branded Pharmaceutical Products R&D, Inc. (part of Teva Pharmaceutical Industries, Ltd.) · Phase 3, Interventional, and Treatment
Primary Objective:
To demonstrate the efficacy of fremanezumab administered as monthly and quarterly subcutaneous (sc) injections to adult Chinese participants with migraine.
Secondary Objectives:
The total study duration for participants is planned to be approximately 9 months. The study will consist of a screening visit, a baseline period (4 weeks), a 12-week double-blind treatment period, a 12-week open-label treatment period, and a follow-up period lasting approximately 3 months after the last dose of treatment.
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
This study's enrollment of 365 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.
Exclusion Criteria:
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
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.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
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.
Double Blind (DB) Period: Participants will receive fremanezumab once a month (approximately every 4 weeks). Participants will receive a single injection of fremanezumab and two placebo injections on Day 1, and a single injection of fremanezumab on Days 29 and 57. Open Label (OL) Period: Participants will receive fremanezumab once a month (approximately every 4 weeks) administered as a single injection on Days 85, 113, and 141.
Drug: Fremanezumab · Drug: Placebo
DB Period: Participants will receive fremanezumab once a quarter (once at the beginning of the 12-week double-blind treatment period). Participants will receive 3 injections of fremanezumab on Day 1, and a single placebo injection on Days 29 and 57. OL Period: Participants will receive fremanezumab once a month (approximately every 4 weeks) administered as a single injection on Days 85, 113, and 141.
Drug: Fremanezumab · Drug: Placebo
DB Period: Participants will receive placebo once a month (approximately every 4 weeks). Participants will receive 3 placebo injections on Day 1, and a single injection of placebo on Days 29 and 57. OL Period: Participants will receive fremanezumab once a month (approximately every 4 weeks) administered as a single injection on Days 85, 113, and 141.
Drug: Placebo
Pharmaceutical form: solution for injection Route of administration: subcutaneous injection
Also known as: TEV-48125, Ajovy
Pharmaceutical form: solution for injection Route of administration: subcutaneous injection
Double Blind (DB) Period: Mean Change From Baseline in Monthly Average Number of Migraine Days During the 12-Week Period After the First Dose of Fremanezumab
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 meeting the criteria for migraine with or without aura or; a calendar day (0:00 to 23:59) demonstrating at least 2 consecutive hours of a headache meeting the criteria for probable migraine, a migraine subtype where only 1 migraine criterion is missing; a calendar day (0:00 to 23:59) demonstrating a headache of any duration that was treated with migraine specific medications (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. Least square (LS) mean was calculated using analysis of covariance (ANCOVA).
Time frame: Baseline (Day -28 to Day -1), up to Week 12
DB Period: Mean Change From Baseline in the Average Number of Migraine Days During the 4-Week Period After the First Dose of Fremanezumab
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 meeting the criteria for migraine with or without aura or; a calendar day (0:00 to 23:59) demonstrating at least 2 consecutive hours of a headache meeting the criteria for probable migraine, a migraine subtype where only 1 migraine criterion is missing; a calendar day (0:00 to 23:59) demonstrating a headache of any duration that was treated with migraine specific medications (triptans and ergot compounds). Monthly averages were derived and normalized to 28 days equivalent by formula: (number of days of efficacy variable over 4-week period/number of days with assessments recorded in e-diary for 4-week period) \* 28.
Time frame: Baseline (Day -28 to Day -1), Up to Week 4
DB Period: Mean Change From Baseline in the Monthly Average Number of Days of Use of Any Acute Headache Medications During the 12-Week Period After the First Dose of Fremanezumab
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 opioids, barbiturates, triptans, ergots, non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen and their combination products. 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
DB Period: Number of Participants Reaching at Least 50% Reduction From Baseline in Monthly Average Number of Migraine Days During the 12-Week Period After the First Dose of Fremanezumab
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 meeting the criteria for migraine with or without aura or; a calendar day (0:00 to 23:59) demonstrating at least 2 consecutive hours of a headache meeting the criteria for probable migraine, a migraine subtype where only 1 migraine criterion is missing; a calendar day (0:00 to 23:59) demonstrating a headache of any duration that was treated with migraine specific medications (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
DB Period: Mean Change From Baseline in the Monthly Average Number of Headache Days of at Least Moderate Severity During the 12-Week Period After the First Dose of Fremanezumab
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 calendar day (0:00 to 23:59) demonstrating at least 2 consecutive hours of headache of at least moderate severity; or a calendar day (0:00 to 23:59) demonstrating a headache of any duration that was treated with migraine-specific acute medications (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
DB Period: Number of Participants With At Least One Treatment-Emergent Adverse Event (TEAE)
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. TEAEs were defined as AEs that occurred after the first dose of study drug was administered through end of the trial. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Time frame: Week 0 up to Week 12
DB Period: Number of Participants Who Did Not Complete the Study Due to AEs
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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. TEAEs were defined as AEs that occurred after the first dose of study drug was administered through end of the trial. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Time frame: Week 0 up to Week 12
OL Period: Number of Participants With at Least One TEAE
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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. TEAEs were defined as AEs that occurred after the first dose of study drug was administered through end of the trial. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Time frame: Week 12 up to Week 24
OL Period: Number of Participants Who Did Not Complete the Study Due to AEs
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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. TEAEs were defined as AEs that occurred after the first dose of study drug was administered through end of the trial. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Time frame: Week 12 up to Week 24
DB Period: Number of Participants Who Received Concomitant Medications for AEs
Concomitant medications included all medications taken while the participant was treated with the study drug. Any concomitant medication received by the participant for AEs was recorded on the case report form (CRF). Concomitant medications included: butalbital for migraine/headache, ergots for migraine/headache, NSAIDs for migraine/headache, NSAIDs for other reason than migraine/headache, opioids for migraine/headache, opioids for reasons other reason than migraine/headache, preventive medication as specified in the protocol for migraine/headache, preventive medication as specified in the protocol for other reason than migraine/headache, triptans for migraine/headache.
Time frame: Week 0 up to Week 12
OL Period: Number of Participants Who Received Concomitant Medications for AEs
Concomitant medications included all medications taken while the participant was treated with the study drug. Any concomitant medication received by the participant for AEs was recorded on the case report form (CRF). Concomitant medications included: butalbital for migraine/headache, ergots for migraine/headache, NSAIDs for migraine/headache, NSAIDs for other reason than migraine/headache, opioids for migraine/headache, opioids for reasons other reason than migraine/headache, preventive medication as specified in the protocol for migraine/headache, preventive medication as specified in the protocol for other reason than migraine/headache, triptans for migraine/headache.
Time frame: Week 12 up to Week 24
Number of Participants With Treatment Emergent Anti-Drug Antibodies (ADA)
Time frame: Day 1 up to Day 225
Number of Participants With Treatment-Emergent Neutralizing Antibodies (NAbs)
Time frame: Day 1 up to Day 225
| Milestone | Placebo | Fremanezumab Monthly | Fremanezumab Quarterly |
|---|---|---|---|
| Started | 183 | 91 | 91 |
| Db safety analysis set | 183 | 91 | 91 |
| Db modified itt (mitt) analysis set | 182 | 90 | 89 |
| Completed | 177 | 87 | 86 |
| Not completed | 6 | 4 | 5 |
| Withdrew: Adverse event | 2 | 1 | 1 |
| Withdrew: Withdrawal by subject | 4 | 1 | 1 |
| Withdrew: Non-compliance with trial drug | 0 | 0 | 1 |
| Withdrew: Protocol deviation | 0 | 2 | 2 |
| Milestone | Placebo | Fremanezumab Monthly | Fremanezumab Quarterly |
|---|---|---|---|
| Started | 175 | 86 | 85 |
| Ol safety analysis set | 175 | 86 | 85 |
| Completed | 174 | 81 | 84 |
| Not completed | 1 | 5 | 1 |
| Withdrew: Adverse event | 1 | 2 | 1 |
| Withdrew: Withdrawal by subject | 0 | 3 | 0 |
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 meeting the criteria for migraine with or without aura or; a calendar day (0:00 to 23:59) demonstrating at least 2 consecutive hours of a headache meeting the criteria for probable migraine, a migraine subtype where only 1 migraine criterion is missing; a calendar day (0:00 to 23:59) demonstrating a headache of any duration that was treated with migraine specific medications (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. Least square (LS) mean was calculated using analysis of covariance (ANCOVA).
| days/month | Placebo | Fremanezumab Monthly/Quarterly |
|---|---|---|
| Double Blind (DB) Period: Mean Change From Baseline in Monthly Average Number of Migraine Days During the 12-Week Period After the First Dose of Fremanezumab | -2.8 ± 0.48 | -4.6 ± 0.48 |
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 meeting the criteria for migraine with or without aura or; a calendar day (0:00 to 23:59) demonstrating at least 2 consecutive hours of a headache meeting the criteria for probable migraine, a migraine subtype where only 1 migraine criterion is missing; a calendar day (0:00 to 23:59) demonstrating a headache of any duration that was treated with migraine specific medications (triptans and ergot compounds). Monthly averages were derived and normalized to 28 days equivalent by formula: (number of days of efficacy variable over 4-week period/number of days with assessments recorded in e-diary for 4-week period) \* 28.
| days | Placebo | Fremanezumab Monthly/Quarterly |
|---|---|---|
| DB Period: Mean Change From Baseline in the Average Number of Migraine Days During the 4-Week Period After the First Dose of Fremanezumab | -2.2 ± 0.52 | -4.5 ± 0.52 |
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 opioids, barbiturates, triptans, ergots, non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen and their combination products. 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.
| days/month | Placebo | Fremanezumab Monthly/Quarterly |
|---|---|---|
| DB Period: Mean Change From Baseline in the Monthly Average Number of Days of Use of Any Acute Headache Medications During the 12-Week Period After the First Dose of Fremanezumab | -1.1 ± 0.41 | -3.0 ± 0.41 |
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 meeting the criteria for migraine with or without aura or; a calendar day (0:00 to 23:59) demonstrating at least 2 consecutive hours of a headache meeting the criteria for probable migraine, a migraine subtype where only 1 migraine criterion is missing; a calendar day (0:00 to 23:59) demonstrating a headache of any duration that was treated with migraine specific medications (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 Monthly/Quarterly |
|---|---|---|
| DB Period: Number of Participants Reaching at Least 50% Reduction From Baseline in Monthly Average Number of Migraine Days During the 12-Week Period After the First Dose of Fremanezumab | 63 | 103 |
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 calendar day (0:00 to 23:59) demonstrating at least 2 consecutive hours of headache of at least moderate severity; or a calendar day (0:00 to 23:59) demonstrating a headache of any duration that was treated with migraine-specific acute medications (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.
| days/month | Placebo | Fremanezumab Monthly/Quarterly |
|---|---|---|
| DB Period: Mean Change From Baseline in the Monthly Average Number of Headache Days of at Least Moderate Severity During the 12-Week Period After the First Dose of Fremanezumab | -2.4 ± 0.43 | -4.5 ± 0.43 |
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. TEAEs were defined as AEs that occurred after the first dose of study drug was administered through end of the trial. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
| Participants | DB Period: Placebo | DB Period: Fremanezumab Monthly | DB Period: Fremanezumab Quarterly |
|---|---|---|---|
| DB Period: Number of Participants With At Least One Treatment-Emergent Adverse Event (TEAE) | 79 | 48 | 37 |
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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. TEAEs were defined as AEs that occurred after the first dose of study drug was administered through end of the trial. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
| Participants | DB Period: Placebo | DB Period: Fremanezumab Monthly | DB Period: Fremanezumab Quarterly |
|---|---|---|---|
| DB Period: Number of Participants Who Did Not Complete the Study Due to AEs | 2 | 1 | 1 |
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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. TEAEs were defined as AEs that occurred after the first dose of study drug was administered through end of the trial. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
| Participants | OL Period: Placebo/Fremanezumab | OL Period: Fremanezumab Monthly | OL Period: Fremanezumab Quarterly |
|---|---|---|---|
| OL Period: Number of Participants With at Least One TEAE | 78 | 40 | 38 |
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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. TEAEs were defined as AEs that occurred after the first dose of study drug was administered through end of the trial. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
| Participants | OL Period: Placebo/Fremanezumab | OL Period: Fremanezumab Monthly | OL Period: Fremanezumab Quarterly |
|---|---|---|---|
| OL Period: Number of Participants Who Did Not Complete the Study Due to AEs | 1 | 1 | 1 |
Concomitant medications included all medications taken while the participant was treated with the study drug. Any concomitant medication received by the participant for AEs was recorded on the case report form (CRF). Concomitant medications included: butalbital for migraine/headache, ergots for migraine/headache, NSAIDs for migraine/headache, NSAIDs for other reason than migraine/headache, opioids for migraine/headache, opioids for reasons other reason than migraine/headache, preventive medication as specified in the protocol for migraine/headache, preventive medication as specified in the protocol for other reason than migraine/headache, triptans for migraine/headache.
| Participants | DB Period: Placebo | DB Period: Fremanezumab Monthly | DB Period: Fremanezumab Quarterly |
|---|---|---|---|
| DB Period: Number of Participants Who Received Concomitant Medications for AEs | 51 | 28 | 23 |
Concomitant medications included all medications taken while the participant was treated with the study drug. Any concomitant medication received by the participant for AEs was recorded on the case report form (CRF). Concomitant medications included: butalbital for migraine/headache, ergots for migraine/headache, NSAIDs for migraine/headache, NSAIDs for other reason than migraine/headache, opioids for migraine/headache, opioids for reasons other reason than migraine/headache, preventive medication as specified in the protocol for migraine/headache, preventive medication as specified in the protocol for other reason than migraine/headache, triptans for migraine/headache.
| Participants | OL Period: Placebo/Fremanezumab | OL Period: Fremanezumab Monthly | OL Period: Fremanezumab Quarterly |
|---|---|---|---|
| OL Period: Number of Participants Who Received Concomitant Medications for AEs | 46 | 26 | 30 |
| Participants | Placebo | Fremanezumab Monthly | Fremanezumab Quarterly |
|---|---|---|---|
| Number of Participants With Treatment Emergent Anti-Drug Antibodies (ADA) | 28 | 11 | 9 |
| Participants | Placebo | Fremanezumab Monthly | Fremanezumab Quarterly |
|---|---|---|---|
| Number of Participants With Treatment-Emergent Neutralizing Antibodies (NAbs) | 27 | 11 | 9 |
Collected over Day 1 up to Day 225. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| DB Period: Placebo | 0/183 (0%) | 1/183 (0.5%) | 30/183 (16.4%) |
| DB Period: Fremanezumab Monthly | 0/91 (0%) | 2/91 (2.2%) | 23/91 (25.3%) |
| DB Period: Fremanezumab Quarterly | 0/91 (0%) | 0/91 (0%) | 15/91 (16.5%) |
| OL Period: Placebo | 0/175 (0%) | 0/175 (0%) | 33/175 (18.9%) |
| OL Period: Fremanezumab Monthly | 0/86 (0%) | 2/86 (2.3%) | 23/86 (26.7%) |
| OL Period: Fremanezumab Quarterly | 0/85 (0%) | 2/85 (2.4%) | 16/85 (18.8%) |
| Event | DB Period: Placebo | DB Period: Fremanezumab Monthly | DB Period: Fremanezumab Quarterly | OL Period: Placebo | OL Period: Fremanezumab Monthly | OL Period: Fremanezumab Quarterly |
|---|---|---|---|---|---|---|
| PneumoniaInfections and infestations | 1/183 | 0/91 | 0/91 | 0/175 | 0/86 | 1/85 |
| NeurodermatitisSkin and subcutaneous tissue disorders | 0/183 | 0/91 | 0/91 | 0/175 | 0/86 | 1/85 |
| VasculitisVascular disorders | 0/183 | 0/91 | 0/91 | 0/175 | 0/86 | 1/85 |
| Pneumonia bacterialInfections and infestations | 0/183 | 0/91 | 0/91 | 0/175 | 1/86 | 0/85 |
| HeadacheNervous system disorders | 0/183 | 0/91 | 0/91 | 0/175 | 1/86 | 0/85 |
| ArrhythmiaCardiac disorders | 0/183 | 1/91 | 0/91 | 0/175 | 0/86 | 0/85 |
| COVID-19 pneumoniaInfections and infestations | 0/183 | 1/91 | 0/91 | 0/175 | 0/86 | 0/85 |
| Event | DB Period: Placebo | DB Period: Fremanezumab Monthly | DB Period: Fremanezumab Quarterly | OL Period: Placebo | OL Period: Fremanezumab Monthly | OL Period: Fremanezumab Quarterly |
|---|---|---|---|---|---|---|
| HyperlipidaemiaMetabolism and nutrition disorders | 3/183 | 1/91 | 5/91 | 3/175 | 9/86 | 2/85 |
| Upper respiratory tract infectionInfections and infestations | 17/183 | 9/91 | 7/91 | 18/175 | 8/86 | 8/85 |
| Injection site erythemaGeneral disorders | 4/183 | 5/91 | 4/91 | 5/175 | 6/86 | 3/85 |
| Injection site swellingGeneral disorders | 6/183 | 5/91 | 2/91 | 7/175 | 6/86 | 4/85 |
| Injection site pruritusGeneral disorders | 1/183 | 6/91 | 3/91 | 5/175 | 5/86 | 3/85 |
| COVID-19Infections and infestations | 6/183 | 5/91 | 2/91 | 4/175 | 0/86 | 1/85 |
The intent-to-treat (ITT) analysis set included all randomized participants.
| Age, Continuous(years) | Placebo | Fremanezumab Monthly | Fremanezumab Quarterly | Total |
|---|---|---|---|---|
| Mean | 38.8 ± 10.03 | 38.6 ± 9.42 | 39.7 ± 10.89 | 38.9 ± 10.09 |
| Sex: Female, Male(Participants) | Placebo | Fremanezumab Monthly | Fremanezumab Quarterly | Total |
|---|---|---|---|---|
| Female | 142 | 71 | 73 | 286 |
| Male | 41 | 20 | 18 | 79 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | Fremanezumab Monthly | Fremanezumab Quarterly | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 183 | 91 | 90 | 364 |
| Unknown or Not Reported | 0 | 0 | 1 | 1 |
| Race (NIH/OMB)(Participants) | Placebo | Fremanezumab Monthly | Fremanezumab Quarterly | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 183 | 91 | 91 | 365 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 |
| White | 0 | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Number of Migraine Days(days) | Placebo | Fremanezumab Monthly | Fremanezumab Quarterly | Total |
|---|---|---|---|---|
| Mean | 11.0 ± 4.96 | 10.4 ± 5.94 | 10.4 ± 5.20 | 10.7 ± 5.27 |
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.
Ran from Sep 2022 to primary completion in Jan 2024, 16 months.
Results were first posted in Jan 2025, 1 year after primary completion.
Of 114 industry-sponsored phase 3 interventional studies under Migraine Disorders, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 31. This study's 16 months is below that.
Counting every sponsor, half of 140 studies reached it within 19 months; a quarter within 12 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2025. 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. →