MigraineNCT06728345
The Real-world Study of Rimegepant Treatment in Female Migraine Patients of China
An observational study of Migraine and Migraine Prophylaxis, run by The First Affiliated Hospital of Soochow University.
Trial summary
The goal of this observational study is to learn about the effects and safety of Rimegepant in women, especially young and middle-aged women, who take Rimegepant to treat their migraine in the real world. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Migraine, Migraine Prophylaxis
- What is being tested?
- Rimegepant
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female patients diagnosed with migraine (with or without aura) who take rimegepant rimegepant 75 mg orally disintegrating tablet every other day for 12 weeks
Who may be able to join
- Female participants aged ≥ 18 years-old
- Primary diagnosis of migraine according to ICHD-3 3.4 or more migraine days during Observation Period and Screening Visit
- 4.Migraine attacks present for more than 1 year 5.Rimegepant is prescribed for the preventive treatment of migraine by physician 6.Written informed consent must be obtained before participant is enrolled 7.Not concurrently participating in other interventional clinical studies.
Who cannot join
- Patients diagnosed with secondary headaches.
- Women who are pregnant or breastfeeding.
- Subjects with severe impairments in language, vision, memory, or cognitive function that affect communication and understanding, or those who are unable to complete questionnaires or follow-ups.
- Subjects lacking the equipment to complete questionnaires on a digital platform.
- Subjects who are allergic to rimegepant or any of its excipients.
- Patients with severe liver damage or end-stage renal disease.
- Patients with a medical history indicating the presence of uncontrolled or unstable cardiovascular disease (such as ischemic heart disease, coronary artery spasm, or cerebral ischemia), or those who have had a myocardial infarction, acute coronary syndrome, percutaneous coronary intervention, cardiac surgery, stroke, or transient ischemic attack within 6 months prior to the screening visit.
- Any condition deemed by the investigator that might affect the patient's participation in the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Real-world Study of Rimegepant for the Preventive Treatment in Female Migraine Patients
The goal of this observational study is to learn about the effects and safety of Rimegepant in women, especially young and middle-aged women, who take Rimegepant to treat their migraine in the real world. Participants already taking Rimegepant (75mg QOD) as their regular preventive treatment of migraine for 12 weeks will be evaluated as the followings :
- To evaluate the change from baseline in the mean number of migraine days per month during weeks 1-12
- To evaluate the number of participants that have least a 50% reduction from baseline in the mean number of migraine days per month during weeks 1-12
Read the detailed description
This single arm, prospective, multi-center, observational registry study aim to evaluate effectiveness of rimegepant as preventive migraine treatment in the real-world setting.
About 300 adult migraine participants will be enrolled continuously at 6 sites with a headache clinic or headache center in China. Subjects who meet the inclusion criteria will be enrolled and will participate in the study. Baseline data including demographic information, socio-economic information, physical examination, medical history, migraine history and past use of headache medications will be collected at the baseline visit. The treatment period will last for 12 weeks during which patients will take rimegepant 75 mg orally disintegrating tablet every other day. The efficacy of rimegepant measured by the reduction in the number of migraine days per month. Subjects will be asked to keep a headache diary to collect monthly headache and migraine days, migraine severity, associated symptoms and drug consumption. Data will be collected at baseline and every month. At study visits, participants will complete the Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder -7 (GAD-7), Headache Impact Test-6 (HIT-6), Pittsburgh Sleep Quality Index (PSQI) at weeks 4, 8 and 12; and participants will complete the Migraine Disability Assessment (MIDAS) at weeks 12.
- Conditions
- Migraine, Migraine Prophylaxis
- Being tested
- Rimegepant
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RimegepantDrug
Female migraine patients take Rimegepant (75mg QOD) as their regular prophylactic treatment of migraine for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| female migraine patients who recevie Rimegepant as prophylactic treatment | Not described Receives: Drug: Rimegepant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from the baseline in the number of migraine days per month over the entire treatment phase (Weeks 1-12)
Change from baseline in mean number of migraine days per month
Measured: The treatment period is 12 weeks
Proportion of subjects with > 50% reduction from the baseline (Weeks 1 to 12)
Number of migraine days per month over the entire treatment phase
Measured: The treatment period is 12 weeks
Secondary outcomes (6)
Mean change from the baseline in the number of moderate or severe migraine days per month over the entire treatment phase (Weeks 1-12)
Change from baseline in mean number of moderate or severe migraine days per month
Measured: The treatment period is 12 weeks
Mean change from baseline in the Migraine Disability Assessment (MIDAS)
Changes in MIDAS score across rimegepant treatment. Participants provide the number of missed work or school days; missed household chores days; missed social or leisure activity days; and days at work or school, and separately at home, where productivity was reduced by half or more in the last 3 months (scale: 0 - 90 for each of 5 subscales). The 5 subscale scores are summed to compute the MIDAS total score (scale: 0 - 450). Lower scores indicate less headache-related disability.
Measured: Baseline, Week 12
Mean change from baseline in the migraine disability (HIT-6)
Changes in Headache Impact Test-6 questionnaire across rimegepant treatment. Headache Impact Test (HIT-6) is a measure of headache severity and provides information regarding the effect of headache on other domains related to functional participation. The HIT-6 has six questions and the range goes from 36 (best outcome) to a maximum score of 78 (worst outcome). Higher HIT-6 scores indicate increased headache severity and greater functional limitations
Measured: Baseline , Week 4,8,12
Mean change from baseline in the Patient Health Questionnaire (PHQ-9)
Changes in PHQ-9 questionnaire across rimegepant treatment. PHQ-9 scoring uses a 4-point Likert scale: 0 = "Not at all," 1 = "Some days," 2 = "More than half the days," and 3 = "Almost every day." With a total score ranging from 0 to 27
Measured: Baseline , Week 4,8,12
Mean change from baseline in the Generalized Anxiety Disorder -7 (GAD-7)
Anxiety level is measured with Generalized Anxiety Disorder 7-item (GAD-7) which is a tool based on seven items which are scored from zero to three. The whole scale score can range from 0 to 21 and cut-off scores for mild, moderate and severe anxiety symptoms are 5, 10 and 15 respectively
Measured: Baseline , Week 4,8,12
Mean change from baseline in the Pittsburgh Sleep Quality Index (PSQI)
Changes in PSQI questionnaire across rimegepant treatment. PSQI is a self-rated questionnaire for sleep quality. It includes 18 items across 7 components; C1: Sleep quality, C2: Sleep latency, C3: Sleep duration, C4: Sleep efficiency, C5: Sleep
Measured: Baseline , Week 4,8,12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start1 Dec 2024 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
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 The First Affiliated Hospital of Soochow UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06728345
- Sponsor's protocol ID
- No.2024-454
- Status last verified
- Dec 2024
- First submitted
- 6 Dec 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Real-world Study of Rimegepant for the Preventive Treatment in Female Migraine Patients
- ClinicalTrials.gov ID
- NCT06728345
- Acronym / sponsor ID
- No.2024-454
- Conditions
- Migraine, Migraine Prophylaxis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 11 Dec 2024 (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 observational study is to learn about the effects and safety of Rimegepant in women, especially young and middle-aged women, who take Rimegepant to treat their migraine in the real world. Participants already taking Rimegepant (75mg QOD) as their regular preventive treatment of migraine for 12 weeks will be evaluated as the followings :
- To evaluate the change from baseline in the mean number of migraine days per month during weeks 1-12
- To evaluate the number of participants that have least a 50% reduction from baseline in the mean number of migraine days per month during weeks 1-12
Detailed description
This single arm, prospective, multi-center, observational registry study aim to evaluate effectiveness of rimegepant as preventive migraine treatment in the real-world setting.
About 300 adult migraine participants will be enrolled continuously at 6 sites with a headache clinic or headache center in China. Subjects who meet the inclusion criteria will be enrolled and will participate in the study. Baseline data including demographic information, socio-economic information, physical examination, medical history, migraine history and past use of headache medications will be collected at the baseline visit. The treatment period will last for 12 weeks during which patients will take rimegepant 75 mg orally disintegrating tablet every other day. The efficacy of rimegepant measured by the reduction in the number of migraine days per month. Subjects will be asked to keep a headache diary to collect monthly headache and migraine days, migraine severity, associated symptoms and drug consumption. Data will be collected at baseline and every month. At study visits, participants will complete the Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder -7 (GAD-7), Headache Impact Test-6 (HIT-6), Pittsburgh Sleep Quality Index (PSQI) at weeks 4, 8 and 12; and participants will complete the Migraine Disability Assessment (MIDAS) at weeks 12.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| female migraine patients who recevie Rimegepant as prophylactic treatment | – | Drug: Rimegepant |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients diagnosed with migraine (with or without aura) who take rimegepant rimegepant 75 mg orally disintegrating tablet every other day for 12 weeks
Key inclusion criteria (3 listed)
- Female participants aged ≥ 18 years-old
- Primary diagnosis of migraine according to ICHD-3 3.4 or more migraine days during Observation Period and Screening Visit
- 4.Migraine attacks present for more than 1 year 5.Rimegepant is prescribed for the preventive treatment of migraine by physician 6.Written informed consent must be obtained before participant is enrolled 7.Not concurrently participating in other interventional clinical studies.
Key exclusion criteria (8 listed)
- Patients diagnosed with secondary headaches.
- Women who are pregnant or breastfeeding.
- Subjects with severe impairments in language, vision, memory, or cognitive function that affect communication and understanding, or those who are unable to complete questionnaires or follow-ups.
- Subjects lacking the equipment to complete questionnaires on a digital platform.
- Subjects who are allergic to rimegepant or any of its excipients.
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 |
|---|---|---|
| RimegepantFemale migraine patients take Rimegepant (75mg QOD) as their regular prophylactic treatment of migraine for 12 weeks | Drug | female migraine patients who recevie Rimegepant as prophylactic treatment |
Primary outcome
Mean change from the baseline in the number of migraine days per month over the entire treatment phase (Weeks 1-12)
Time frame: The treatment period is 12 weeks
Change from baseline in mean number of migraine days per month
Proportion of subjects with > 50% reduction from the baseline (Weeks 1 to 12)
Time frame: The treatment period is 12 weeks
Number of migraine days per month over the entire treatment phase
6 secondary outcomes
Mean change from the baseline in the number of moderate or severe migraine days per month over the entire treatment phase (Weeks 1-12)
Time frame: The treatment period is 12 weeks
Mean change from baseline in the Migraine Disability Assessment (MIDAS)
Time frame: Baseline, Week 12
Mean change from baseline in the migraine disability (HIT-6)
Time frame: Baseline , Week 4,8,12
Mean change from baseline in the Patient Health Questionnaire (PHQ-9)
Time frame: Baseline , Week 4,8,12
Mean change from baseline in the Generalized Anxiety Disorder -7 (GAD-7)
Time frame: Baseline , Week 4,8,12
Mean change from baseline in the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline , Week 4,8,12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine and Migraine Prophylaxis, run by The First Affiliated Hospital of Soochow University.
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 3 inclusion and 8 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: opening soon, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact HongRu Zhao, M.D (18051212086, tiantan11@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change from the baseline in the number of migraine days per month over the entire treatment phase (Weeks 1-12) (time frame: The treatment period is 12 weeks). The study lists 2 primary outcomes in all. 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 11 Dec 2024.