An observational study in Refractory Chronic Migraine, sponsored by Clinique des Céphalées de Montréal. Completed at 1 site in Canada. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-11-05.
Sponsored by Clinique des Céphalées de Montréal · Observational
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
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)
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's enrollment of 158 is above the median of 130 across 299 observational studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →This is the only study on the registry with Clinique des Céphalées de Montréal as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
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)
Drug: Erenumab Auto-Injector
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.
Drug: Erenumab Auto-Injector
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%
Drug: Erenumab Auto-Injector
Assess synergy of add on medication to Erenumab
Also known as: Botox, and oral migraine preventives
Change in monthly migraine days
Change in frequency of monthly migraine days
Time frame: 5 months
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,
Time frame: 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
Time frame: 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
Time frame: 5 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.