Hemicrania Continua
Conditions
Brief summary
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.
Interventions
DRUGErenumab
140 mg of erenumab via subcutaneous injection
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 66 Years
Healthy volunteers
No
Inclusion criteria
* Adults over the age of 18-66 * At least a 12 month history of hemicrania continua (unremitting subtype) according to International Classification of Headache Disorders, 3rd Edition (ICHD-3)1 * Previous or current complete response to indomethacin * Stable preventive treatment for at least 2 months and no anticipated need to adjust/add current headache prevention treatment
Exclusion criteria
* Nonresponse to a therapeutic dose of indomethacin for hemicrania continua when used for at least 1 week * Pregnant or lactating subjects * Use of barbiturate or opioid \>6 days per month; history of chronic migraine * History of previous trigeminal-autonomic cephalalgia * History within previous 2 months of interventional procedure for headache (occipital or other extracranial nerve block, sphenopalatine ganglion block, cervical facet block, facet rhizotomy) * History of cranial nerve/rhizolysis * Botulinumtoxin injection with previous 4 months * Parenteral infusion of or oral corticosteroid use for more than 3 days within 4 weeks prior to screening phase
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Headache Days | 4 weeks post erenumab treatment | The total number of days per month (28 days) with headache of any kind/severity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Migraine Days | 4 weeks post erenumab treatment | Total number of days per month (28 days) with migraines |
| Headache Freedom | 4 weeks post erenumab treatment | Total number of days per month (28 days) with complete headache freedom |
| Remission Rate | 4 weeks post erenumab treatment | Number of participants who do not have any occurrence of headache |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment With Erenumab Subjects diagnosed with hemicrania continua received single dose of Erenumab
Erenumab: 140 mg of erenumab via subcutaneous injection | 2 |
| Total | 2 |
Baseline characteristics
| Characteristic | Treatment With Erenumab |
|---|---|
| Age, Continuous | 58.5 years STANDARD_DEVIATION 19 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Region of Enrollment United States | 2 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 2 |
| other Total, other adverse events | 1 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
Primary
Headache Days
The total number of days per month (28 days) with headache of any kind/severity
Time frame: 4 weeks post erenumab treatment
Population: Terminated study due to low enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment With Erenumab | Headache Days | 24.5 days | Standard Deviation 4.9 |
Secondary
Headache Freedom
Total number of days per month (28 days) with complete headache freedom
Time frame: 4 weeks post erenumab treatment
Population: Terminated study due to low enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment With Erenumab | Headache Freedom | 3.5 days | Standard Deviation 4.9 |
Secondary
Migraine Days
Total number of days per month (28 days) with migraines
Time frame: 4 weeks post erenumab treatment
Population: Terminated study due to low enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment With Erenumab | Migraine Days | 0.5 days | Standard Deviation 0.7 |
Secondary
Remission Rate
Number of participants who do not have any occurrence of headache
Time frame: 4 weeks post erenumab treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment With Erenumab | Remission Rate | 0 Participants |