Trial · NCT06728345
The Real-world Study of Rimegepant Treatment in Female Migraine Patients of China
NCT06728345, Not yet recruiting, The First Affiliated Hospital of Soochow University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Real-world Study of Rimegepant Treatment in Female Migraine Patients of China. Trials, record NCT06728345. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06728345
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Real-world Study of Rimegepant Treatment in Female Migraine Patients of China
- NCT number
- NCT06728345
- Status
- Not yet recruiting
- Enrollment
- 300 participants, estimated
- Lead sponsor
- The First Affiliated Hospital of Soochow University
- Conditions
- Migraine, Migraine Prophylaxis
- Interventions
- Rimegepant
- First posted
- 2024-12-11
- Last updated
- 2024-12-11
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean change from the baseline in the number of migraine days per month over the entire treatment phase (Weeks 1-12) | The treatment period is 12 weeks | Change from baseline in mean number of migraine days per month |
| Primary | Proportion of subjects with > 50% reduction from the baseline (Weeks 1 to 12) | The treatment period is 12 weeks | Number of migraine days per month over the entire treatment phase |
| Secondary | Mean change from the baseline in the number of moderate or severe migraine days per month over the entire treatment phase (Weeks 1-12) | The treatment period is 12 weeks | Change from baseline in mean number of moderate or severe migraine days per month |
| Secondary | Mean change from baseline in the Migraine Disability Assessment (MIDAS) | Baseline, Week 12 | 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. |
| Secondary | Mean change from baseline in the migraine disability (HIT-6) | Baseline , Week 4,8,12 | 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 |
| Secondary | Mean change from baseline in the Patient Health Questionnaire (PHQ-9) | Baseline , Week 4,8,12 | 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 |
| Secondary | Mean change from baseline in the Generalized Anxiety Disorder -7 (GAD-7) | Baseline , Week 4,8,12 | 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 |
| Secondary | Mean change from baseline in the Pittsburgh Sleep Quality Index (PSQI) | Baseline , Week 4,8,12 | 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 |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06728345
GET https://conductscience.org/api/trials/v1/NCT06728345/registered