Erenumab For Treatment of Hemicrania Continua
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 19-007088
NCT ID: NCT04303845
Sponsor Protocol Number: 19-007088
About this study
The purposes of this study are to evaluate the response of hemicrania continua to treatment with erenumab, and to evaluate the safety and tolerability of erenumab in patients with hemicrania continua.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Adults ages 18 and older.
- 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 an oral corticosteroid use for more than 3 days within 4 weeks prior to screening phase.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Rashmi Halker Singh, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available