Status MigrainosusPhase 1NCT04920331
Study of Intravenous Erenumab in Patients With Status Migrainosus
A Phase 1 study testing Erenumab in people with Status Migrainosus, run by Mayo Clinic at 1 site in United States.
Trial summary
The investigators will evaluate the efficacy for use of intravenous erenumab 140mg for treatment of status migrainosus in an open-label, pilot study. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Status Migrainosus
- 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
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2021to 4 Feb 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years to 70 years.
- History of migraines (with or without aura) for ≥ 12 months and history of at least 1 episode of status migrainosus based on medical records and/or patient self-report in their lifetime.
- Currently experiencing an episode of status migrainosus (non-menstrually related) per ICHD3 criteria of ≥ 3 and < 6 days.
- Migraine frequency: ≥ 2 and < 10 migraine days per month on average across the 3 months prior to screening.
- Headache (i.e., migraine and non-migraine headache) frequency: < 15 headache days per month on average across the 3 months prior to screening.
- Agree to withhold acute treatments for 24 hours after receiving erenumab IV unless medically necessary.
Who cannot join
- Older than 50 years of age at migraine onset.
- History of cluster headache or hemiplegic migraine headache.
- Past (within 4 months) or present exposure to a CGRP monoclonal antibody or CGRP small molecule receptor antagonist for migraine treatment.
- Present exposure to lasmiditan.
- New acute treatment within 7 days.
- New preventive treatment within 4 weeks.
Show all 25Show fewer
- > 15 days acute treatment use, opioid or barbiturate use > 4 days per month.
- Use of acute treatment within 6 hours of the infusion.
- Unable to differentiate migraine from other headaches.
- Procedures (e.g., nerve blocks) or neuromodulatory devices within 7 days.
- History of major psychiatric disorder.
- History or evidence of any unstable or clinically significant medical condition, that in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
- History of myocardial infarction, stroke, transient ischemic attack, unstable angina, coronary artery bypass surgery, or other revascularization procedures within 12 months prior to screening.
- Females who are pregnant, breastfeeding, or who are trying to become pregnant.
- Not willing to use a reliable form of contraception (for women of childbearing potential) through 16 weeks after the last dose of erenumab. Acceptable methods of birth control include not having intercourse, hormonal birth control methods, intrauterine devices, surgical contraceptive methods, or two barrier methods (each partner must use a barrier method) with spermicide. A reliable form of contraception must be started prior to or at the time of starting the run-in phase. Not being of childbearing potential is defined as any woman who:
- Is post-menopausal by history, defined as:
- At least 55 years of age with cessation of menses for 12 or more months; OR
- Younger than 55 years of age but no spontaneous menses for at least 2 years; OR
- Younger than 55 years of age and spontaneous menses within the past 1 year, but currently amenorrheic (e.g., spontaneous or secondary to hysterectomy), AND with postmenopausal gonadotropin levels (luteinizing hormone and follicle-stimulating hormone levels at least 40 IU/L) or postmenopausal estradiol level (less than 5 ng/dL) or according to the definition of "postmenopausal range" for the laboratory involved; OR
- Underwent bilateral oophorectomy; OR
- Underwent hysterectomy; OR
- Underwent bilateral salpingectomy.
- Currently receiving treatment in another drug study or an investigational device study, or less than 90 days prior to screening since ending treatment on another investigational device or drug study(-ies).
- Unable to provide informed consent.
- Unlikely to be able to complete all protocol required study visits or procedures, and/or to comply with all required study procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: STATUS STUDY: Pilot Open-Label Trial of Intravenous Erenumab in Patients With Status Migrainosus
The investigators will evaluate the efficacy for use of intravenous erenumab 140mg for treatment of status migrainosus in an open-label, pilot study.
Read the detailed description
This will be a single-center, open-label, pilot study. The investigators will enroll 15 subjects. Subjects will be recruited from the outpatient Mayo Headache Clinic. The Headache Clinic employs 5 headache specialists and 1 fellow which is sufficient staffing to support this study and recruitment of patients with status migrainosus.
Subject participation would be for a total of 28 days. Subjects will be screened at outpatient clinic visit appointments or when they call into the clinic regarding an episode of status migrainosus and interested qualified subjects will be consented and offered participation in this trial.
Once consent has been obtained, subjects will have evaluation of vital signs, pregnancy status, complete blood count, and comprehensive metabolic panel. Abnormal metabolic profile, kidney or liver function will exclude subjects. Pregnancy will exclude subjects. Qualifying subjects will be administered a single dose of intravenous erenumab at our Infusion Center at the first available appointment within 24 hours of qualifying for participation if they continue to have moderate to severe pain and monitored on-site for a minimum of 2 hours after start of drug administration.
Subjects will fill out two headache diaries following treatment. The first diary is an hourly diary with entries once every hour for 24 hours, with time point 0 defined as time of when treatment begins. Diary entry at hour 24 coincides with the time point for post-treatment day 1. Follow-up will occur by phone at post-treatment day 1. If pain and symptoms persist, patients will be directed to contact their primary headache provider to receive further management. From this point and onwards, patients will be instructed to fill out a second diary once daily for 28 consecutive calendar days following treatment. A final visit will be conducted at the end of the study at 28 days.
- Conditions
- Status Migrainosus
- Being tested
- Erenumab
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErenumabBiological
140mg single intravenous administration (60 minutes)
| Study group | Role | What they receive |
|---|---|---|
| Erenumab | Experimental | Subjects with episodes of status migrainosus will receive a single dose of IV erenumab Receives: Biological: Erenumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief at 2 hours
Number of subjects with decreased pain from moderate or severe at baseline to mild or none at 2 hours after treatment
Measured: 2 hours after treatment
Secondary outcomes (11)
Pain freedom at 2 hours
Number of subjects who become pain free at 2 hours after treatment.
Measured: 2 hours after treatment
Absence of most bothersome symptom at 2 hours
Number of subjects with absence of most bothersome symptom at 2 hours after treatment.
Measured: 2 hours after treatment
Relief of most bothersome symptom at 2 hours
Number of subjects with decrease in most bothersome symptom from moderate or severe at baseline to mild or none at 2 hours after treatment.
Measured: 2 hours after treatment
Pain freedom at 24 hours
Number of subjects who become pain free at 24 hours after treatment
Measured: 24 hours after treatment
Pain relief at 24 hours
Number of subjects with decrease in pain from moderate or severe at baseline to mild or none at 24 hours after treatment
Measured: 24 hours after treatment
Sustained pain freedom at 24 hours
Number of subjects who are pain free at 24 hours with no use of rescue medications or relapse within 24 hours of the initial treatment.
Measured: 24 hours after treatment
Sustained pain freedom at 48 hours
Number of subjects who are pain free at 48 hours with no use of rescue medications or relapse within 48 hours of the initial treatment.
Measured: 48 hours after treatment
Sustained pain relief at 24 hours
Number of subjects who have pain relief at 24 hours with no use of rescue medications or relapse within 24 hours of the initial treatment.
Measured: 24 hours after treatment
Sustained pain relief at 48 hours
Number of subjects who have pain relief at 48 hours with no use of rescue medications or relapse within 48 hours of the initial treatment.
Measured: 48 hours after treatment
Change in pain intensity at 2 hours
Measured using a self-reported questionnaire to rate headache pain on a numerical rating scale from 0-10, where 0 is no pain and 10 is the worst pain imaginable.
Measured: Baseline, 2 hours
Change in pain intensity at 24 hours
Measured using a self-reported questionnaire to rate headache pain on a numerical rating scale from 0-10, where 0 is no pain and 10 is the worst pain imaginable.
Measured: Baseline, 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start7 Sep 2021
- Primary completion4 Feb 2022
- Study completion4 Feb 2022
Why it stopped: No Participants Enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Status MigrainosusStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juliana H. VanderPluym, Mayo Clinic
- Investigators
- Juliana VanderPluym, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04920331
- Sponsor's protocol ID
- 19-006424
- Status last verified
- Feb 2022
- First submitted
- 3 Jun 2021
- Last updated
- 22 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STATUS STUDY: Pilot Open-Label Trial of Intravenous Erenumab in Patients With Status Migrainosus
- ClinicalTrials.gov ID
- NCT04920331
- Acronym / sponsor ID
- 19-006424
- Conditions
- Status Migrainosus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No Participants Enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 7 Sep 2021 (actual)
- Primary completion
- 4 Feb 2022 (actual)
- Study completion
- 4 Feb 2022 (actual)
- First posted
- 9 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will evaluate the efficacy for use of intravenous erenumab 140mg for treatment of status migrainosus in an open-label, pilot study.
Detailed description
This will be a single-center, open-label, pilot study. The investigators will enroll 15 subjects. Subjects will be recruited from the outpatient Mayo Headache Clinic. The Headache Clinic employs 5 headache specialists and 1 fellow which is sufficient staffing to support this study and recruitment of patients with status migrainosus.
Subject participation would be for a total of 28 days. Subjects will be screened at outpatient clinic visit appointments or when they call into the clinic regarding an episode of status migrainosus and interested qualified subjects will be consented and offered participation in this trial.
Once consent has been obtained, subjects will have evaluation of vital signs, pregnancy status, complete blood count, and comprehensive metabolic panel. Abnormal metabolic profile, kidney or liver function will exclude subjects. Pregnancy will exclude subjects. Qualifying subjects will be administered a single dose of intravenous erenumab at our Infusion Center at the first available appointment within 24 hours of qualifying for participation if they continue to have moderate to severe pain and monitored on-site for a minimum of 2 hours after start of drug administration.
Subjects will fill out two headache diaries following treatment. The first diary is an hourly diary with entries once every hour for 24 hours, with time point 0 defined as time of when treatment begins. Diary entry at hour 24 coincides with the time point for post-treatment day 1. Follow-up will occur by phone at post-treatment day 1. If pain and symptoms persist, patients will be directed to contact their primary headache provider to receive further management. From this point and onwards, patients will be instructed to fill out a second diary once daily for 28 consecutive calendar days following treatment. A final visit will be conducted at the end of the study at 28 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Erenumab | Experimental | Biological: ErenumabSubjects with episodes of status migrainosus will receive a single dose of IV erenumab |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years to 70 years.
- History of migraines (with or without aura) for ≥ 12 months and history of at least 1 episode of status migrainosus based on medical records and/or patient self-report in their lifetime.
- Currently experiencing an episode of status migrainosus (non-menstrually related) per ICHD3 criteria of ≥ 3 and < 6 days.
- Migraine frequency: ≥ 2 and < 10 migraine days per month on average across the 3 months prior to screening.
- Headache (i.e., migraine and non-migraine headache) frequency: < 15 headache days per month on average across the 3 months prior to screening.
Key exclusion criteria (25 listed)
- Older than 50 years of age at migraine onset.
- History of cluster headache or hemiplegic migraine headache.
- Past (within 4 months) or present exposure to a CGRP monoclonal antibody or CGRP small molecule receptor antagonist for migraine treatment.
- Present exposure to lasmiditan.
- New acute treatment within 7 days.
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 |
|---|---|---|
| Erenumab140mg single intravenous administration (60 minutes) | Biological | Erenumab |
Primary outcome
Pain relief at 2 hours
Time frame: 2 hours after treatment
Number of subjects with decreased pain from moderate or severe at baseline to mild or none at 2 hours after treatment
11 secondary outcomes
Pain freedom at 2 hours
Time frame: 2 hours after treatment
Absence of most bothersome symptom at 2 hours
Time frame: 2 hours after treatment
Relief of most bothersome symptom at 2 hours
Time frame: 2 hours after treatment
Pain freedom at 24 hours
Time frame: 24 hours after treatment
Pain relief at 24 hours
Time frame: 24 hours after treatment
Sustained pain freedom at 24 hours
Time frame: 24 hours after treatment
Sustained pain freedom at 48 hours
Time frame: 48 hours after treatment
Sustained pain relief at 24 hours
Time frame: 24 hours after treatment
Sustained pain relief at 48 hours
Time frame: 48 hours after treatment
Change in pain intensity at 2 hours
Time frame: Baseline, 2 hours
Change in pain intensity at 24 hours
Time frame: Baseline, 24 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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.
Juliana VanderPluym, 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 1 study testing Erenumab in people with Status Migrainosus, 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 6 inclusion and 25 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: withdrawn, as of the sponsor's last update on 22 Feb 2022. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Pain relief at 2 hours (time frame: 2 hours after 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 22 Feb 2022.