A Phase 2 interventional study of Erenumab in Hemicrania Continua, sponsored by Mayo Clinic. Terminated at 1 site in United States. Open to participants aged 18 Years to 66 Years. Per ClinicalTrials.gov, last updated 2023-02-17.
Sponsored by Mayo Clinic · Phase 2, Interventional, and Treatment
This research is being conducting to learn if the study drug erenumab is successful in treating hemicrania continua. The study is also evaluating the safety and tolerability of erenumab in individuals being treated for hemicrania continua.
1,226 studies on the registry are indexed under Headache; 202 are open to participants now.
This study's enrollment of 2 is below the median of 60 across 918 interventional studies indexed under Headache.
Browse Headache studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
Subjects diagnosed with hemicrania continua will receive single dose of Erenumab
Drug: Erenumab
140 mg of erenumab via subcutaneous injection
Headache Days
The total number of days per month (28 days) with headache of any kind/severity
Time frame: 4 weeks post erenumab treatment
Migraine Days
Total number of days per month (28 days) with migraines
Time frame: 4 weeks post erenumab treatment
Headache Freedom
Total number of days per month (28 days) with complete headache freedom
Time frame: 4 weeks post erenumab treatment
Remission Rate
Number of participants who do not have any occurrence of headache
Time frame: 4 weeks post erenumab treatment
| Milestone | Treatment With Erenumab |
|---|---|
| Started | 2 |
| Completed | 2 |
| Not completed | 0 |
The total number of days per month (28 days) with headache of any kind/severity
| days | Treatment With Erenumab |
|---|---|
| Headache Days | 24.5 ± 4.9 |
Total number of days per month (28 days) with migraines
| days | Treatment With Erenumab |
|---|---|
| Migraine Days | 0.5 ± 0.7 |
Total number of days per month (28 days) with complete headache freedom
| days | Treatment With Erenumab |
|---|---|
| Headache Freedom | 3.5 ± 4.9 |
Number of participants who do not have any occurrence of headache
| Participants | Treatment With Erenumab |
|---|---|
| Remission Rate | 0 |
Collected over Adverse Events were collected from baseline to end of study, approximately 8 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment With Erenumab | 0/2 (0%) | 0/2 (0%) | 1/2 (50%) |
| Event | Treatment With Erenumab |
|---|---|
| Worsening of pre-existing medical conditionGeneral disorders | 1/2 |
| Age, Continuous(years) | Treatment With Erenumab |
|---|---|
| Mean | 58.5 ± 19.0 |
| Sex: Female, Male(Participants) | Treatment With Erenumab |
|---|---|
| Female | 1 |
| Male | 1 |
| Ethnicity (NIH/OMB)(Participants) | Treatment With Erenumab |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 2 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Treatment With Erenumab |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 1 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Treatment With Erenumab |
|---|---|
| United States | 2 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is terminated, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Anencephaly
Mayo Clinic