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Erenumab For Treatment of Hemicrania Continua

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT04303845
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
13.9
Anticipated Duration (Months)
1.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Erenumab For Treatment of Hemicrania Continua
Actual Study Start Date :
Aug 4, 2021
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Sep 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment with Erenumab

Subjects diagnosed with hemicrania continua will receive single dose of Erenumab

Drug: Erenumab
140 mg of erenumab via subcutaneous injection

Outcome Measures

Primary Outcome Measures

  1. Total number of participants to have a response rate of 50% or greater reduction of headache frequency after treatment [4 weeks post erenumab treatment]

Secondary Outcome Measures

  1. Change in number of headaches experienced by participants [Baseline, 4 weeks post erenumab treatment]

  2. Change in the amount of total headache hours (with moderate or severe pain) experienced by participants [Baseline, 4 weeks post erenumab treatment]

  3. Remission rate [4 weeks post erenumab treatment]

    Number of participants who do not have any occurrence of headache

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 66 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic in Arizona Scottsdale Arizona United States 85259

Sponsors and Collaborators

  • Mayo Clinic

Investigators

  • Principal Investigator: Rashmi Halker Singh, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Rashmi B. Halker Singh MD, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT04303845
Other Study ID Numbers:
  • 19-007088
First Posted:
Mar 11, 2020
Last Update Posted:
Sep 24, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Anencephaly
Headache
Erenumab

Study Results

No Results Posted as of Sep 24, 2021