Migraine Menopause Study
NCT07916571, Phase 4, Not yet recruiting, Alberta Neurologic Centre
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Migraine Menopause Study | ClinicalTrials.gov |
| NCT number | NCT07916571 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 4 | ClinicalTrials.gov |
| Enrollment | 120 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Alberta Neurologic Centre | ClinicalTrials.gov |
| Conditions | Migraine, Menopausal, Perimenopause | ClinicalTrials.gov |
| Interventions | Eptinezumab 100 mg or Eptinezumab 300 mg administered intravenously in 100 mL saline solution, Placebo Normal Saline (NS), Eptinezumab 100 mg or Eptinezumab 300 mg administered intravenously in 100 mL saline solution | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-04 | ClinicalTrials.gov |
Registered outcomes 8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change from baseline in average monthly migraine days (MMDs) during weeks 1-12 | Weeks 1-12 | The primary endpoint will be the change from baseline in average monthly migraine days (MMDs) during weeks 1-12. Monthly migraine days will be derived from participant diary entries using the prespecified migraine-day definition applied consistently across baseline and follow-up periods. The primary analysis will compare eptinezumab and placebo using analysis of covariance (ANCOVA), with treatment group as the main independent variable and baseline MMDs included as a covariate. The adjusted between-group mean difference will be reported with a 95% confidence interval and two-sided p-value. | ClinicalTrials.gov |
| Secondary | Changes in migraine disability assessment (MIDAS) scores | Weeks 1-12 | Migraine disability assessment (MIDAS) is a standardized questionnaire that measures how much migraines disrupt the participants life over the course of 3 months. MIDAS classifies disability from Grade I (0-5, little or no disability), Grade II (6-10, mild disability), Grade III (11-20, moderate disability), Grade IV (21+ severe disability) Changes in MIDAS scores will be analyzed using ANCOVA or an appropriate repeated-measures model, depending on the timing and distribution of the measurements. | ClinicalTrials.gov |
| Secondary | Change in patient global impression of change (PGIC) | Weeks 1-12 | The patient global impression of change is a 7 point Likert scale patient reported measure that rates overall change since treatment began ranging from "very much improved" to "very much worse". PGIC responses will be summarized descriptively and compared between groups using appropriate ordinal or categorical methods. | ClinicalTrials.gov |
| Secondary | Change in monthly acute medication use days. | Weeks 1-12 | The number of acute monthly medication use days will be recorded and compared between the two groups and analyzed with ANCOVA, or an appropriate repeated-measures model. | ClinicalTrials.gov |
| Other | Exploratory outcome: Vasomotor symptom frequency and severity | Weeks 1-12 | Vasomotor symptom frequency and severity will be recorded by the participants. Participants will record the number of hot flashes and night sweats that they experienced per month and will rate the severity from mild to severe. Vasomotor symptom frequency will be analyzed with ANCOVA, or an appropriate repeated-measures model. | ClinicalTrials.gov |
| Other | Exploratory measure: menopause rating scale (MRS) | Weeks 1-12 | The menopause rating scale is an 11 item questionnaire that scores somatic (hot flashes, night sweats, heart discomfort, sleep problems, joint and muscle discomfort), psychological (depressive mood, irritability, anxiety, physical and mental exhaustion), and urogenital (sexual problems, vaginal dryness, bladder issues) menopause symptoms from 0-4 each producing domain scores and a total score from 0-44. Score ranges from none/very mild (0-4), mild (5-8), moderate (9-16), to severe (17+) Changes in the MRS will be analyzed with ANCOVA, or an appropriate repeated-measures model. | ClinicalTrials.gov |
| Other | Exploratory measure: Patient health questionnaire 9 (PHQ-9) | Weeks 1-12 | The patient health questionnaire 9 (PHQ-9) is a validated tool incorporating DSM IV criteria for major depressive disorder. It assesses symptom frequency over the preceding 2 weeks. Score range from minimal depression (1-4), mild depression (5-9), moderate depression (10-14), moderately severe depression (15-19), severe depression (20-27). Changes in the PHQ-9 will be analyzed with ANCOVA, or an appropriate repeated-measures model. | ClinicalTrials.gov |
| Other | Exploratory measure: Generalized anxiety disorder 7 (GAD-7) | Weeks 1-12 | The generalized anxiety disorder 7 (GAD-7) is a validated screening tool for generalized anxiety disorder, scored from 0-21 with cutoffs at 5 (mild), 10 (moderate), and 15 (severe). GAD-7 asks how often symptoms occurred over the past 2 weeks. Changes in the GAD-7 will be analyzed with ANCOVA, or an appropriate repeated-measures model. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 10646700 | BACKGROUND | PubMed |
Grants 0
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)