MigrainePhase 4NCT06173661
Fremanezumab Treatment of Migraine in Women With Menstrual Migraine Ages 18-45
A Phase 4 study testing Fremanezumab in people with Migraine and Menstrual Migraine, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn about how a migraine prevention medicine works for people who have migraines/headaches with their menstrual period. The study includes people ages 18 to 45 who have been diagnosed with migraine and who have a migraine with their menstrual period or those who have migraines… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Migraine, Menstrual Migraine, Menstrually Related Migraine
- What is being tested?
- Fremanezumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2024to 13 Jul 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients may be randomized in this study only if they meet all of the following criteria:
- The patient is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in this protocol
- The patient is female aged 18 to 45 years of age, inclusive
- The patient has a diagnosis of pure menstrual migraine (MM) or menstrual-related migraine (MRM)
- Prior to the screening visit (V1) the patient has a 6 month history of either:
- Menstrual Migraine (MM)
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- Headache consistent with Menstrual Migraine (MM)
- Menstrually-Related Migraine (MRM)
- The patient fulfils the following criteria for migraine in a prospectively collected diary during the 28-day baseline period:
- ○ Migraine attacks starting in the peri-menstrual period (days -2 to +3 of menstruation)
- AND
- Pure Menstrual migraine with aura, either/or
- Menstrually-related migraine with aura, either/or
- Pure Menstrual migraine without aura, either/or
- Menstrually-related migraine without aura
- The patient agrees not to initiate any migraine preventive medications during the study
- The patient is in good health in the opinion of the sponsor as determined by medical evaluation, including medical history, neurologic examination, laboratory tests and cardiac monitoring
- The patient has a body weight ≥45 kg and a body mass index within the range of 17.5 to 34.9 kg/m^2, inclusive
- The patient demonstrated compliance with the electronic headache diary during the 28-day baseline period by entry of headache data on a minimum of 21 days cumulative during the 28-day baseline period (~diary compliance)
- Three months of regular menstrual cycle prior to baseline period and 1 regular cycle (within 21-28 days) of previous cycle during the baseline run-in period
- Patients not using birth control must have a negative urine beta-human chorionic gonadotrophin(β-HCG) test at the Screening Visit (V1), and must not be in a sexual relationship with a person who produces sperm or must be medically confirmed as sterile. These conditions must be met from the baseline period through the entire duration of study and 5.5 months after the last dose of fremanezumab.
- Patients using birth control must have a negative β-HCG test result and practice a highly effective method of birth control prior to treatment administration and 5.5 months following the last dose of IMP. Birth control permitted should allow estrogen drop and maintenance of monthly cycle: estrogen/progesterone pills; etonogestrel/ethinylestradiol ring; copper intrauterine device (IUD) and progesterone-containing IUD and have been on their current birth control for ≥30 days.
- The patient must be willing and able to comply with study restrictions and attend the clinic for all study visits required for the duration of the study and to attend follow up evaluations, as specified in the protocol
Who cannot join
- Patients will not be randomized/enrolled in this study if they meet any of the following criteria:
- The patient uses medications containing opioids or barbiturates on more than 4 days during the 28-day baseline period for the treatment of migraine or any other reason
- The patient uses >8 rimegepant or ubrogepant tablets per month
- The patient has ≥15 headache days per month
- The patient has used am intervention/device (eg, scheduled nerve blocks, implantable vagal nerve stimulation, and transcranial magnetic stimulation) for migraine during the 2 months prior to screening
- The patient is overusing acute medication
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- The patient is pregnant or lactating or planning to get pregnant in ≤13 months post screening visit (V1)
- The patient has clinically significant hematological, cardiac, renal, endocrine, pulmonary, gastrointestinal, genitourinary, neurologic, hepatic or ocular disease, at the discretion of the sponsor
- The patient has a history of clinically significant cardiovascular disease or vascular ischemia (such as myocardial, neurological [eg, cerebral ischemia], peripheral extremity ischemia, or other ischemic event) or thromboembolic events (arterial or venous thrombotic or embolic events), such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism
- The patient has a known infection or history of human immunodeficiency virus, tuberculosis, any history of Lyme disease, or chronic hepatitis B or C infection
- The patient has a past or current history of cancer, except for appropriately treated non-melanoma skin carcinoma
- The patient has a history of hypersensitivity reactions to injected proteins, including monoclonal antibodies
- The patient has participated in a clinical study of a new chemical entity or a prescription medicine within 2 months of the screening visit (V1) or 3 months in case of biologics if the half-life of the biologics is unknown or 5 half-lives, whichever is longer, or is currently participating in another study of an IMP (or a medical device)
- The patient has previously received treatment with any calcitonin generelated peptide pathway (ligand/receptor) target therapy(erenumab, eptinezumab, galcanezumab, fremanezumab, rimegepant 75 mg every other day, or atogepant) or is actively taking them during the study
- The patient has any finding in the baseline 12-lead electrocardiogram considered clinically significant in the judgment of the sponsor
- The patient has any finding that, in the judgment of the sponsor, is a clinically significant abnormality, including serum chemistry, hematology, coagulation, and urinalysis test values (abnormal tests may be repeated for confirmation)
- The patient has a prior medical history of hepatic enzymes (alanine aminotransferase, aspartate aminotransferase, and alkaline phosphatase) >1.5x the upper limit of the normal range or suspected hepatocellular damage that fulfills the criteria for Hy's law during their prior medical history review at screening visit.
- The patient has a prior medical history of significant proteinuria or evidence of renal disease at the Screening Visit (V1).
- The patient has any clinically significant uncontrolled medical condition (treated or untreated). The patient has a history of alcohol or drug abuse in the opinion of the sponsor
- The patient cannot participate or successfully complete the study, in the opinion of their healthcare provider or the sponsor, for any of the following reasons:
- mentally or legally incapacitated or unable to give consent for any reason
- in custody due to an administrative or a legal decision, under tutelage, or being admitted to a sanitarium or social institution
- unable to be contacted in case of emergency
- has any other condition, which, in the opinion of the sponsor, makes the patient in appropriate for inclusion in the study
- The patient is an employee who is directly involved in the study or the relative of such an employee
- The patient has any disorder that may interfere with the absorption, distribution, metabolism, or excretion of IMP
- The patient is vulnerable (eg, people kept in detention)
- The patient has previously participated in this study
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Health Care Center
Chestnut Hill, Massachusetts, 02467
About this study
Official title: A Single Center, Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Fremanezumab (675 mg Quarterly) in Female Patients Aged 18-45 With Menstrual Migraine
The goal of this clinical trial is to learn about how a migraine prevention medicine works for people who have migraines/headaches with their menstrual period. The study includes people ages 18 to 45 who have been diagnosed with migraine and who have a migraine with their menstrual period or those who have migraines with their menstrual period and at other times of the month as well.
The main question the study aims to answer are:
Read more
- Does fremanazemab, an injectable calcitonin gene-related peptide (CGRP) pathway targeting therapy, decrease migraines associated with menstruation?
Participants will
- have an evaluation and examination by a headache specialist physician
- will receive the study medicine or inactive substitute every three months for two treatments
- fill out diaries about their migraines
- have tests on saliva to measure hormone levels
Researchers will compare the people who get the medicine to those who get the inactive substitute to see if there are differences in response.
Read the detailed description
Patients who meet the eligibility criteria and wish to participate will be consented, and will then be randomized to receive two rounds of treatment with either fremanezumab or placebo, administered 3 months apart, to understand efficacy and response in decreasing migraine days. The investigators will monitor with daily logs and use evidenced metrics to assess response. Participants will be carefully screened to ensure that they do not become pregnant while in the study. The investigators will measure monthly hormone levels using salivary samples. Each participant will have three in-person visits and will have five 5 visits via secure telehealth. The investigators are studying decreased headache days, severity, disability and quality of life.
- Conditions
- Migraine, Menstrual Migraine, Menstrually Related Migraine
- Being tested
- Fremanezumab, Placebo
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FremanezumabDrug
Also called AJOVY
The intervention will be active medication.
PlaceboOther
The intervention will be placebo injection.
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving active medication | Active comparator | These patients will receive 675 mg of fremanezumab for two total doses administered 3 months apart. Receives: Drug: Fremanezumab |
| Patients receiving placebo | Placebo comparator | These patients will receive placebo injections for two total doses administered 3 months apart. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Migraine Days
The number of active migraine days during the 24-week treatment period after the 1st dose of study drug.
Measured: 6 months
Secondary outcomes (10)
Migraine Duration
The number of migraine hours of any severity experienced in the 24-week treatment period.
Measured: 6 months
Migraine Severity
Headache severity will be subjectively rated by the patient as follows: mild headache, moderate headache, and severe headache.
Measured: 6 months
Migraine Specific Quality of Life Measure
The Migraine Specific Quality of Life (MSQoL) scale is a 14 item questionnaire that assesses the impact of migraine and migraine treatment on a patient's quality of life during the previous 4 weeks. The MSQoL measures the degree to which performance of normal activities is limited by migraine, the degree to which performance of normal activities is prevented by migraine and the emotional effects of migraine. Scores range from 0 to 100, with higher scores indicating better health-related quality of life.
Measured: 6 months
Responder Status
Responder status is defined as 50% or more reduction from the 28 day baseline period in the monthly average number of migraine days during the 24 week treatment period.
Measured: 6 months
Disability (MIDAS)
Mean change from randomization at the end of 24-week treatment period in disability score for overall impact as measured by the Migraine Disability Assessment Test (MIDAS) questionnaire at the following time points:
- Weeks 12 and 24
This questionnaire measures the impact of the patient's headaches on their life during the previous 3 months. A higher score on the MIDAS indicates a higher grade of disability. The grade is determined as follows: Grade 1 (scores ranging from 0 to 5): little or no disability; Grade 2 (scores ranging from 6 to 10): mild disability; Grade 3 (scores ranging from 11 to 20): moderate disability; Grade 4 (21 or greater): severe disability.
Measured: 6 months
Disability (HIT-6)
Mean change from randomization at end of 24-week treatment period in disability score for overall impact as measured by the Headache Impact Test (HIT-6) questionnaire at the following time points:
- Weeks 4, 8, 12, 16, 20 and 24
The questionnaire measures the adverse impact of headache on social functioning, role functioning, vitality, cognitive functioning, and psychological distress. It also assesses headache severity. It is scored by a simple summation of the six items and ranges between 36 and 78, with larger scores reflecting greater impact.
Measured: 6 months
Rescue Medication Use
Decrease from baseline at end of 24-week treatment period in the average use of acute rescue medications per migraine attack.
Measured: 6 months
Depression (PHQ-9)
The Patient Health Questionnaire (PHQ-9) is a 9-item questionnaire with each item corresponding to 1 criterion of the Diagnostic and Statistical Manual for Mental Disorders 4th edition diagnostic criteria for Major depressive disorder. Each of the items is scored on a scale of 0 ("not at all"), 1 ("several days"), 2 ("more than half the days"), and 3 ("nearly every day") based on the frequency of symptoms during the past 2 weeks. The PHQ-9 is a validated measure for detecting and monitoring depression, anxiety, and somatization. Higher scores indicate higher severity of depressive symptoms.
Measured: 6 months
Anxiety (GAD-7)
The Generalized Anxiety Disorder Assessment-7 (GAD-7) is a self-reported questionnaire for screening and severity measuring of generalized anxiety disorder. The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3 to the response categories of "not at all," "several days," "more than half the days," and "nearly every day" respectively, and adding together the scores for the seven questions.
Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate, and severe anxiety, respectively.
Measured: 6 months
Sleep Quality (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. The trend in changes of sleep quality from baseline will be assessed. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start1 Mar 2024
- Primary completion5 May 2026
- Study completion13 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, single center, double blind, placebo-controlled clinical trial with a non-crossover, parallel group study design that will select 72 patients who meet criteria and randomize half to receive active medication and half to receive placebo. A research pharmacist will randomize the patients; the study team will be blinded.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Teva Pharmaceuticals USA
- Responsible party
- Principal investigator, Carolyn A. Bernstein, Brigham and Women's Hospital
- Investigators
- Carolyn A Bernstein, MD, Principal investigator, Brigham and Women's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06173661
- Sponsor's protocol ID
- 2023p002389
- Status last verified
- Aug 2026
- First submitted
- 28 Nov 2023
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Fremanezumab (675 mg Quarterly) in Female Patients Aged 18-45 With Menstrual Migraine
- ClinicalTrials.gov ID
- NCT06173661
- Acronym / sponsor ID
- 2023p002389
- Conditions
- Migraine, Menstrual Migraine, Menstrually Related Migraine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Teva Pharmaceuticals USA
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 5 May 2026 (actual)
- Study completion
- 13 Jul 2026 (actual)
- First posted
- 18 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn about how a migraine prevention medicine works for people who have migraines/headaches with their menstrual period. The study includes people ages 18 to 45 who have been diagnosed with migraine and who have a migraine with their menstrual period or those who have migraines with their menstrual period and at other times of the month as well.
The main question the study aims to answer are:
- Does fremanazemab, an injectable calcitonin gene-related peptide (CGRP) pathway targeting therapy, decrease migraines associated with menstruation?
Participants will
- have an evaluation and examination by a headache specialist physician
- will receive the study medicine or inactive substitute every three months for two treatments
- fill out diaries about their migraines
- have tests on saliva to measure hormone levels
Researchers will compare the people who get the medicine to those who get the inactive substitute to see if there are differences in response.
Detailed description
Patients who meet the eligibility criteria and wish to participate will be consented, and will then be randomized to receive two rounds of treatment with either fremanezumab or placebo, administered 3 months apart, to understand efficacy and response in decreasing migraine days. The investigators will monitor with daily logs and use evidenced metrics to assess response. Participants will be carefully screened to ensure that they do not become pregnant while in the study. The investigators will measure monthly hormone levels using salivary samples. Each participant will have three in-person visits and will have five 5 visits via secure telehealth. The investigators are studying decreased headache days, severity, disability and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This is a randomized, single center, double blind, placebo-controlled clinical trial with a non-crossover, parallel group study design that will select 72 patients who meet criteria and randomize half to receive active medication and half to receive placebo. A research pharmacist will randomize the patients; the study team will be blinded.
| Arm | Type | Receives |
|---|---|---|
| Patients receiving active medication | Active comparator | Drug: FremanezumabThese patients will receive 675 mg of fremanezumab for two total doses administered 3 months apart. |
| Patients receiving placebo | Placebo comparator | Other: PlaceboThese patients will receive placebo injections for two total doses administered 3 months apart. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (23 listed)
- The patient is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in this protocol
- The patient is female aged 18 to 45 years of age, inclusive
- The patient has a diagnosis of pure menstrual migraine (MM) or menstrual-related migraine (MRM)
- Prior to the screening visit (V1) the patient has a 6 month history of either:
- The patient fulfils the following criteria for migraine in a prospectively collected diary during the 28-day baseline period:
Key exclusion criteria (28 listed)
- Patients will not be randomized/enrolled in this study if they meet any of the following criteria:
- The patient uses medications containing opioids or barbiturates on more than 4 days during the 28-day baseline period for the treatment of migraine or any other reason
- The patient uses >8 rimegepant or ubrogepant tablets per month
- The patient has ≥15 headache days per month
- The patient has used am intervention/device (eg, scheduled nerve blocks, implantable vagal nerve stimulation, and transcranial magnetic stimulation) for migraine during the 2 months prior to screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FremanezumabAlso: AJOVYThe intervention will be active medication. | Drug | Patients receiving active medication |
| PlaceboThe intervention will be placebo injection. | Other | Patients receiving placebo |
Primary outcome
Migraine Days
Time frame: 6 months
The number of active migraine days during the 24-week treatment period after the 1st dose of study drug.
10 secondary outcomes
Migraine Duration
Time frame: 6 months
Migraine Severity
Time frame: 6 months
Migraine Specific Quality of Life Measure
Time frame: 6 months
Responder Status
Time frame: 6 months
Disability (MIDAS)
Time frame: 6 months
Disability (HIT-6)
Time frame: 6 months
Rescue Medication Use
Time frame: 6 months
Depression (PHQ-9)
Time frame: 6 months
Anxiety (GAD-7)
Time frame: 6 months
Sleep Quality (PSQI)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolyn A Bernstein, MD principal investigator
Brigham and Women's
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fremanezumab in people with Migraine and Menstrual Migraine, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Migraine Days (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.