Erenumab For Treatment of Hemicrania Continua

Hemicrania Continua Clinical Trial

Official title:

Erenumab For Treatment of Hemicrania Continua

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04303845
• Other study ID #: 19-007088
• Status: Terminated
• Phase: Phase 2
• Start date: August 4, 2021
• Est. completion date: April 6, 2022

Study information

• Verified date: January 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: April 6, 2022
• Est. primary completion date: April 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 66 Years

Eligibility

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

Related Conditions & MeSH terms

• Anencephaly
• Headache
• Hemicrania Continua

Intervention

Drug:
• Erenumab
140 mg of erenumab via subcutaneous injection

Locations

Country	Name	City	State
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Headache Days	The total number of days per month (28 days) with headache of any kind/severity	4 weeks post erenumab treatment
Secondary	Migraine Days	Total number of days per month (28 days) with migraines	4 weeks post erenumab treatment
Secondary	Headache Freedom	Total number of days per month (28 days) with complete headache freedom	4 weeks post erenumab treatment
Secondary	Remission Rate	Number of participants who do not have any occurrence of headache	4 weeks post erenumab treatment

External Links

•   Mayo Clinic Clinical Trials