Refractory Chronic MigraineNCT04152434
Treatment of Chronic Migraine With Erenumab Alone or as an Add on Therapy
An observational study of Refractory Chronic Migraine, run by Clinique des Céphalées de Montréal at 1 site in Canada.
Trial summary
Treatment of chronic migraineurs who have failed more than 3 preventive drugs with Erenumab alone, to reduce frequency of monthly migraine days or as an add on therapy Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Refractory Chronic Migraine
- What is being tested?
- Erenumab Auto-Injector
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 158 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2019to 30 Aug 2019
- Phase
- Observational
- 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
Study population: patients with more than 15 migraine days per month, receiving Botox, or an oral preventive treatment, or without any preventive therapy. Have failed more than 3 preventive treatments previously
Who may be able to join
- chronic migraineurs with failure to more than 3 preventive treatments
- Naive to anti CGRP monclonal antibodies
Who cannot join
- episodic migraineurs,
- Other headache types
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Chronic Migraine With Erenumab Alone or as an Add on Therapy; a Real World Prospective Observational Study
Treatment of chronic migraineurs who have failed more than 3 preventive drugs with Erenumab alone, to reduce frequency of monthly migraine days or as an add on therapy
Read the detailed description
The investigators treated chronic migraineurs that have failed more than 3 preventive drugs with Erenumab alone or as an add on therapy to: Reduce the frequency of monthly migraine days, to evaluate If the add on of Erenumab to another preventive therapy is superior to Erenumab alone, and assess all adverse events related to the use of Erenumab.
Migraineurs with 15-30 migraie days per month at baseline were clustered in 3 categories. Failure of Erenumab was defined as no improvement in the frequency of monthly migraine days. Group I: no preventive therapy, prior to the start of Erenumab. (No botox cohort). Group II: on Botulinum Toxin A (Botox), prior to the add on therapy with Erenumab. (Botox cohort).Group III: on an oral preventive drug, prior to the add on therapy with Erenumab. (No Botox cohort)
- Conditions
- Refractory Chronic Migraine
- Being tested
- Erenumab Auto-Injector
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erenumab Auto-InjectorDrug
Also called Botox, and oral migraine preventives
Assess synergy of add on medication to Erenumab
| Study group | Role | What they receive |
|---|---|---|
| Reduction in monthly migraine days all cohorts at 4 months | Migraineurs with 15-30 headache days per month at baseline were clustered in 3 categories. Failure of Erenumab was defined as no improvement in the frequency of monthly headache days. Group I: no preventive therapy, prior to the start of Erenumab. (No botox cohort). Group II: on Botulinum Toxin A (Botox), prior to the add on therapy with Erenumab. (Botox cohort).Group III: on an oral preventive drug, prior to the add on therapy with Erenumab. (No Botox cohort) Receives: Drug: Erenumab Auto-Injector | |
| Selection of elegible paitients | A total of 158 patients were involved in this study. 118 patients (75%), received Erenumab 140 mg., and 40 patients (25%) received 70 mg. In the Botox cohort, of 650 patients, 90 (13%) patients were eligible. In the no Botox cohort, 533 patients, 83 (15%) patients were eligible. Receives: Drug: Erenumab Auto-Injector | |
| Rate of adverse events related to Erenumab | 72 adverse events were experienced during the 4 months of treatment, mostly with the 140 mg. dose. The most frequent were: constipation 34%, fatigue 19%, itching 7.5%, muscle cramps 6.3%, increased headache 4.4%, rhinitis 4.4%, injection site discomfort 3.7%, lack of energy 3.1% Receives: Drug: Erenumab Auto-Injector |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in monthly migraine days
Change in frequency of monthly migraine days
Measured: 5 months
Secondary outcomes (3)
Change in frequency of monthly migraine days adding Erenumab to another preventive treatment,
Change in the frequency of monthly migraine days with Botox plus Erenumab,
Measured: 5 months
Change in the frequency of monthly migraine days adding Erenumab to another preventive treatment
Change in the freqyency of monthly migraine days with an oral preventive plu erenumab
Measured: 5 months
change in frequency of monthly migraine days with Erenumab alone
change in frequency of monthly migraine days without adding another preventive to Erenumab
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start1 Apr 2019
- Primary completion30 Jul 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Chronic MigraineStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique des Céphalées de Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guy Pierre Boudreau md, Clinique des Céphalées de Montréal
- Investigators
- Guy P Boudreau, md, Principal investigator, Clinique des Céphalées de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04152434
- Sponsor's protocol ID
- Erenumab 01
- Status last verified
- Nov 2019
- First submitted
- 30 Oct 2019
- Last updated
- 5 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Chronic Migraine With Erenumab Alone or as an Add on Therapy; a Real World Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04152434
- Acronym / sponsor ID
- Erenumab 01
- Conditions
- Refractory Chronic Migraine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Clinique des Céphalées de MontréalUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 5 Nov 2019 (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.
Treatment of chronic migraineurs who have failed more than 3 preventive drugs with Erenumab alone, to reduce frequency of monthly migraine days or as an add on therapy
Detailed description
The investigators treated chronic migraineurs that have failed more than 3 preventive drugs with Erenumab alone or as an add on therapy to: Reduce the frequency of monthly migraine days, to evaluate If the add on of Erenumab to another preventive therapy is superior to Erenumab alone, and assess all adverse events related to the use of Erenumab.
Migraineurs with 15-30 migraie days per month at baseline were clustered in 3 categories. Failure of Erenumab was defined as no improvement in the frequency of monthly migraine days. Group I: no preventive therapy, prior to the start of Erenumab. (No botox cohort). Group II: on Botulinum Toxin A (Botox), prior to the add on therapy with Erenumab. (Botox cohort).Group III: on an oral preventive drug, prior to the add on therapy with Erenumab. (No Botox cohort)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Reduction in monthly migraine days all cohorts at 4 months | – | Drug: Erenumab Auto-InjectorMigraineurs with 15-30 headache days per month at baseline were clustered in 3 categories. Failure of Erenumab was defined as no improvement in the frequency of monthly headache days. Group I: no preventive therapy, prior to the start of Erenumab. (No botox cohort). Group II: on Botulinum Toxin A (Botox), prior to the add on therapy with Erenumab. (Botox cohort).Group III: on an oral preventive drug, prior to the add on therapy with Erenumab. (No Botox cohort) |
| Selection of elegible paitients | – | Drug: Erenumab Auto-InjectorA total of 158 patients were involved in this study. 118 patients (75%), received Erenumab 140 mg., and 40 patients (25%) received 70 mg. In the Botox cohort, of 650 patients, 90 (13%) patients were eligible. In the no Botox cohort, 533 patients, 83 (15%) patients were eligible. |
| Rate of adverse events related to Erenumab | – | Drug: Erenumab Auto-Injector72 adverse events were experienced during the 4 months of treatment, mostly with the 140 mg. dose. The most frequent were: constipation 34%, fatigue 19%, itching 7.5%, muscle cramps 6.3%, increased headache 4.4%, rhinitis 4.4%, injection site discomfort 3.7%, lack of energy 3.1% |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with more than 15 migraine days per month, receiving Botox, or an oral preventive treatment, or without any preventive therapy. Have failed more than 3 preventive treatments previously
Key inclusion criteria (2 listed)
- chronic migraineurs with failure to more than 3 preventive treatments
- Naive to anti CGRP monclonal antibodies
Key exclusion criteria (2 listed)
- episodic migraineurs,
- Other headache types
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 |
|---|---|---|
| Erenumab Auto-InjectorAlso: Botox, and oral migraine preventivesAssess synergy of add on medication to Erenumab | Drug | Rate of adverse events related to Erenumab, Reduction in monthly migraine days all cohorts at 4 months, Selection of elegible paitients |
Primary outcome
Change in monthly migraine days
Time frame: 5 months
Change in frequency of monthly migraine days
3 secondary outcomes
Change in frequency of monthly migraine days adding Erenumab to another preventive treatment,
Time frame: 5 months
Change in the frequency of monthly migraine days adding Erenumab to another preventive treatment
Time frame: 5 months
change in frequency of monthly migraine days with Erenumab alone
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2019.
- 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.
Guy P Boudreau, md principal investigator
Clinique des Céphalées de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Refractory Chronic Migraine, run by Clinique des Céphalées de Montréal at 1 site in Canada.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 5 Nov 2019. 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 Canada. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in monthly migraine days (time frame: 5 months). 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 5 Nov 2019.