Erenumab For Treatment of Hemicrania Continua

January 25, 2023 updated by: Rashmi B. Halker Singh MD, Mayo Clinic
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic in Arizona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Headache Days
Time Frame: 4 weeks post erenumab treatment
The total number of days per month (28 days) with headache of any kind/severity
4 weeks post erenumab treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Migraine Days
Time Frame: 4 weeks post erenumab treatment
Total number of days per month (28 days) with migraines
4 weeks post erenumab treatment
Headache Freedom
Time Frame: 4 weeks post erenumab treatment
Total number of days per month (28 days) with complete headache freedom
4 weeks post erenumab treatment
Remission Rate
Time Frame: 4 weeks post erenumab treatment
Number of participants who do not have any occurrence of headache
4 weeks post erenumab treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 4, 2021

Primary Completion (Actual)

April 6, 2022

Study Completion (Actual)

April 6, 2022

Study Registration Dates

First Submitted

March 9, 2020

First Submitted That Met QC Criteria

March 10, 2020

First Posted (Actual)

March 11, 2020

Study Record Updates

Last Update Posted (Actual)

February 17, 2023

Last Update Submitted That Met QC Criteria

January 25, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-007088

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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