Back to resultsErenumab For Treatment of Hemicrania Continua
Primary Purpose
Hemicrania Continua
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Erenumab
Sponsored by
About this trial
This is an interventional treatment trial for Hemicrania Continua
Eligibility Criteria
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
Sites / Locations
- Mayo Clinic in Arizona
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment with Erenumab
Arm Description
Subjects diagnosed with hemicrania continua will receive single dose of Erenumab
Outcomes
Primary Outcome Measures
Headache Days
The total number of days per month (28 days) with headache of any kind/severity
Secondary Outcome Measures
Migraine Days
Total number of days per month (28 days) with migraines
Headache Freedom
Total number of days per month (28 days) with complete headache freedom
Remission Rate
Number of participants who do not have any occurrence of headache
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04303845
Brief Title
Erenumab For Treatment of Hemicrania Continua
Official Title
Erenumab For Treatment of Hemicrania Continua
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Terminated
Why Stopped
difficulty with recruitment
Study Start Date
August 4, 2021 (Actual)
Primary Completion Date
April 6, 2022 (Actual)
Study Completion Date
April 6, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemicrania Continua
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment with Erenumab
Arm Type
Experimental
Arm Description
Subjects diagnosed with hemicrania continua will receive single dose of Erenumab
Intervention Type
Drug
Intervention Name(s)
Erenumab
Intervention Description
140 mg of erenumab via subcutaneous injection
Primary Outcome Measure Information:
Title
Headache Days
Description
The total number of days per month (28 days) with headache of any kind/severity
Time Frame
4 weeks post erenumab treatment
Secondary Outcome Measure Information:
Title
Migraine Days
Description
Total number of days per month (28 days) with migraines
Time Frame
4 weeks post erenumab treatment
Title
Headache Freedom
Description
Total number of days per month (28 days) with complete headache freedom
Time Frame
4 weeks post erenumab treatment
Title
Remission Rate
Description
Number of participants who do not have any occurrence of headache
Time Frame
4 weeks post erenumab treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rashmi Halker Singh, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Erenumab For Treatment of Hemicrania Continua
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