Study Stopped
difficulty with recruitment
Erenumab For Treatment of Hemicrania Continua
1 other identifier
interventional
2
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Aug 2021
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 9, 2020
CompletedFirst Posted
Study publicly available on registry
March 11, 2020
CompletedStudy Start
First participant enrolled
August 4, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 6, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 6, 2022
CompletedResults Posted
Study results publicly available
February 17, 2023
CompletedFebruary 17, 2023
January 1, 2023
8 months
March 9, 2020
January 25, 2023
January 25, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Headache Days
The total number of days per month (28 days) with headache of any kind/severity
4 weeks post erenumab treatment
Secondary Outcomes (3)
Migraine Days
4 weeks post erenumab treatment
Headache Freedom
4 weeks post erenumab treatment
Remission Rate
4 weeks post erenumab treatment
Study Arms (1)
Treatment with Erenumab
EXPERIMENTALSubjects diagnosed with hemicrania continua will receive single dose of Erenumab
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
Related Links
MeSH Terms
Interventions
Limitations and Caveats
Terminated study due to low enrollment
Results Point of Contact
- Title
- Rashmi B. Halker Singh, M.D.
- Organization
- Mayo Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Rashmi Halker Singh, MD
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 9, 2020
First Posted
March 11, 2020
Study Start
August 4, 2021
Primary Completion
April 6, 2022
Study Completion
April 6, 2022
Last Updated
February 17, 2023
Results First Posted
February 17, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share