Erenumab For Treatment of Hemicrania Continua

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-04

Study Completion Date

2022-04-06

Brief Summary

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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.

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Detailed Description

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Conditions

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Hemicrania Continua

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment with Erenumab

Subjects diagnosed with hemicrania continua will receive single dose of Erenumab

Group Type EXPERIMENTAL

Erenumab

Intervention Type DRUG

140 mg of erenumab via subcutaneous injection

Interventions

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Erenumab

140 mg of erenumab via subcutaneous injection

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

66 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No