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difficulty with recruitment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with Erenumab | Experimental | Subjects diagnosed with hemicrania continua will receive single dose of Erenumab |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erenumab | Drug | 140 mg of erenumab via subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Headache Days | The total number of days per month (28 days) with headache of any kind/severity | 4 weeks post erenumab treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Migraine Days | Total number of days per month (28 days) with migraines | 4 weeks post erenumab treatment |
| Headache Freedom | Total number of days per month (28 days) with complete headache freedom |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Rashmi Halker Singh, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment With Erenumab | Subjects diagnosed with hemicrania continua received single dose of Erenumab Erenumab: 140 mg of erenumab via subcutaneous injection |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment With Erenumab | Subjects diagnosed with hemicrania continua received single dose of Erenumab Erenumab: 140 mg of erenumab via subcutaneous injection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Headache Days | The total number of days per month (28 days) with headache of any kind/severity | Terminated study due to low enrollment | Posted | Mean | Standard Deviation | days | 4 weeks post erenumab treatment |
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Adverse Events were collected from baseline to end of study, approximately 8 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment With Erenumab | Subjects diagnosed with hemicrania continua received single dose of Erenumab Erenumab: 140 mg of erenumab via subcutaneous injection |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Worsening of pre-existing medical condition | General disorders | Systematic Assessment |
Terminated study due to low enrollment
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rashmi B. Halker Singh, M.D. | Mayo Clinic | 480-301-8100 | Halker.Rashmi@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 6, 2021 | Jan 25, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C000605816 | erenumab |
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| 4 weeks post erenumab treatment |
| Remission Rate | Number of participants who do not have any occurrence of headache | 4 weeks post erenumab treatment |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Migraine Days | Total number of days per month (28 days) with migraines | Terminated study due to low enrollment | Posted | Mean | Standard Deviation | days | 4 weeks post erenumab treatment |
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| Secondary | Headache Freedom | Total number of days per month (28 days) with complete headache freedom | Terminated study due to low enrollment | Posted | Mean | Standard Deviation | days | 4 weeks post erenumab treatment |
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| Secondary | Remission Rate | Number of participants who do not have any occurrence of headache | Posted | Count of Participants | Participants | 4 weeks post erenumab treatment |
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| 0 |
| 2 |
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