Migraine Disorders
Conditions
Keywords
Eptinezumab,, Calcitonin gene-related peptide,, Effectiveness,, Real-life,, Migraine,, Safety, Treatment
Brief summary
The object of this study is to assess the effectiveness, safety, and tolerability of eptinezumab in a real life migraine population.
Detailed description
Eptinezumab is an humanized IgG1 and the only antiCGRP mAb administered intravenously by a quarterly dosing regimen. In randomized-controlled studies (RCTs), eptinezumab proved to be effective in preventing episodic and chronic migraine even in patients with 2 to 4 prior preventive failures and in shortening the time to complete migraine freedom when infused during a moderate-to severe migraine attack. Eptinezumab 100 mg can be used for the first administration and later if deemed necessary, the dose upgraded to 300 mg. EMBRACE is a multicenter, prospective, cohort, real-life study carried out in Italian headache centers. Consecutive patients with high frequency episodic (HFEM: ≥8 migraine days/month) or CM (≥15 headache days/month), according to The International Classification of Headache Disorders, 3rd edition (ICHD-III), referred to participating centers. The aim of this study is to assess effectiveness, safety and tolerability of eptinezumab 100 mg iv or 300 mg iv with a quarterly dosing regimen in a real-world migraine patients population.
Interventions
DRUGEptinezumab 100 mg or Eptinezumab 300 mg administered intravenously in 100 mL saline solution
migraine prophylaxis
Sponsors
IRCCS San Raffaele Roma
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
KEY INCLUSION CRITERIA 1. Age between 18 and 75 years; 2. Males and females; 3. Willingness to sign the informed consent; 4. High frequency episodic migraine, at least 8 days per month of disabling migraine in the past 3 months; 5. Chronic migraine, according to the ICHD-III criteria; KEY
Exclusion criteria
1. Other headaches different than migraine; 2. Known intolerance to eptinezumab or eccipients; 3. Current treatment with other mAbs; 4. Vascular disease or Raynaud.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in monthly migraine days (MMD) in HFEM or monthly headache days (MHD) in CM; | over 12 weeks of treatment compared to baseline | assessment of MMD or MHD |
| Change from baseline in MMD in HFEM or MHD in CM; | over 24 weeks of treatment compared to baseline | assessment of MMD or MHD |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | over 12 months of treatment compared to baseline | assessment of occurrence of Treatment-Emergent Adverse Events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Migraine Disability Assessment Score (MIDAS) | over 12 weeks compared to baseline | Assessment of MIDAS |
| Change in Migraine interictal burden (MIBS-4) | over 12 weeks compared to baseline | Assessment of MIBS-4 |
| Change in Patient Global Impression of change (PGIC) scale | over 12 weeks compared to baseline | Assessment of MIBS |
| Change in monthly analgesic intake | over 12 weeks compared to baseline | Assessment of monthly analgesic intake |
| Percentage of migraine free patients on the day after dosing (infusion of eptinezumab) | the day after infusion of eptinezumab (first infusion of eptinezumab) | Assessment of percentage of migraine free patients on the day after dosing (first infusion of eptinezumab) |
| Proportion of patients with medication overuse at baseline reverting to no medication overuse | over 12 weeks compared to baseline | Assessment of proportion of patients with medication overuse at baseline reverting to no medication overuse |
| ≥50%, ≥75% and 100% response rates | over 12 weeks compared to baseline | Assessment of responder rates |
| Change in Numeric Rating Scale (NRS) | over 12 weeks compared to baseline | Assessment of NRS |
| Change in Headache Impact Test-6 (HIT-6) | over 12 weeks compared to baseline | Assessment of HIT-6 |
Countries
Italy
Contacts
Primary ContactPiero Barbanti, MD, PhD
Backup ContactCinzia Aurilia, MD
Outcome results
None listed