Hemicrania ContinuaPhase 2NCT04303845
Erenumab For Treatment of Hemicrania Continua
A Phase 2 study testing Erenumab in people with Hemicrania Continua, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 66 years
- Conditions the study is for
- Hemicrania Continua
- What is being tested?
- Erenumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Aug 2021to 6 Apr 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 66 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Hemicrania Continua
- Being tested
- Erenumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErenumabDrug
140 mg of erenumab via subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Treatment with Erenumab | Experimental | Subjects diagnosed with hemicrania continua will receive single dose of Erenumab Receives: Drug: Erenumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache Days
The total number of days per month (28 days) with headache of any kind/severity
Measured: 4 weeks post erenumab treatment
Secondary outcomes (3)
Migraine Days
Total number of days per month (28 days) with migraines
Measured: 4 weeks post erenumab treatment
Headache Freedom
Total number of days per month (28 days) with complete headache freedom
Measured: 4 weeks post erenumab treatment
Remission Rate
Number of participants who do not have any occurrence of headache
Measured: 4 weeks post erenumab treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start4 Aug 2021
- Primary completion6 Apr 2022
- Study completion6 Apr 2022
Why it stopped: difficulty with recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hemicrania ContinuaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rashmi B. Halker Singh MD, Mayo Clinic
- Investigators
- Rashmi Halker Singh, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04303845
- Sponsor's protocol ID
- 19-007088
- Status last verified
- Jan 2023
- First submitted
- 9 Mar 2020
- Last updated
- 17 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erenumab For Treatment of Hemicrania Continua
- ClinicalTrials.gov ID
- NCT04303845
- Acronym / sponsor ID
- 19-007088
- Conditions
- Hemicrania Continua
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulty with recruitment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 4 Aug 2021 (actual)
- Primary completion
- 6 Apr 2022 (actual)
- Study completion
- 6 Apr 2022 (actual)
- First posted
- 11 Mar 2020 (actual)
- Results
- Posted 17 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with Erenumab | Experimental | Drug: ErenumabSubjects diagnosed with hemicrania continua will receive single dose of Erenumab |
Who may qualify
- Ages
- 18 to 66 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erenumab140 mg of erenumab via subcutaneous injection | Drug | Treatment with Erenumab |
Primary outcome
Headache Days
Time frame: 4 weeks post erenumab treatment
The total number of days per month (28 days) with headache of any kind/severity
3 secondary outcomes
Migraine Days
Time frame: 4 weeks post erenumab treatment
Headache Freedom
Time frame: 4 weeks post erenumab treatment
Remission Rate
Time frame: 4 weeks post erenumab treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rashmi Halker Singh, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Erenumab in people with Hemicrania Continua, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache Days (time frame: 4 weeks post erenumab treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2023.