Episodic migraine MedDRA version: 20.0 Level: PT Classification code 10027599 Term: Migraine System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: AMG334
Product Code: [AMG334]
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Erenumab
CAS Number: 1582205-90-0
Current Sponsor code: AMG334
Other descriptive name: Eren
Sponsors
NOVARTIS FARMA S.P.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adult patients, aged between 18 and 65 years 2) Provided informed consent 3) History of migraine with or without aura for at least 12 months prior to screening according to IHS classification ICHD-3, based on medical records and/or patient self-report 4) Migraine frequency: = 4 and =65 years) yes F.1.3.1 Number of subjects for this age range 3
Exclusion criteria
Exclusion criteria: 1) Older than 50 years of age at migraine onset. 2) History of cluster headache or hemiplegic migraine headache. 3) History of head trauma or seizure or major psychiatric disorders. 4) Currently receiving (or have received less than 60 days or 5 half-lives prior to the start of the baseline period, during the baseline period, or treatment period) any other prophylactic treatment for migraine and/or prohibited medications, non-pharmacologic interventions or devices (any substance, non-pharmacologic intervention or device acting at central nervous system). 5) Pregnant or breastfeeding. 6) All the clinical conditions for which undergoing an MRI scan is contraindicated.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To evaluate, in a cohort of episodic migraine patients, whether the prophylactic treatment of 3 months with erenumab is able to produce significant changes versus placebo in the functional recruitment and connectivity of multisensory processing areas and, as such, modulate the dysfunctional pain network (chosen as primary area of interest) in the CNS of these patients. 2. To evaluate whether the changes of functional recruitment and connectivity in multisensory processing areas are different between the two groups of clinical responders (reduction by 50% in monthly migraine days, MMD, in the last month vs baseline) and non-responders within each 3-months treatment group.;Secondary Objective: 1. To evaluate whether the functional changes in the pain network produced by prophylactic treatment of 3 months with erenumab correlate with the clinical response over 3 months; 2. To evaluate whether prophylaptic treatment of 3 months with erenumab is able to produce significant changes versus placebo in the functional recruitment and connectivity of multisensory processing areas mediating symptoms commonly experienced by migraine patients, such as allodynia, photophobia, phonophobia, nausea, anxiety and depression; 3. To evaluate whether the functional changes produced by prophylaptic treatment of 3 months with erenumab in the dysfunctional brain regions mediating allodynia, photophobia, phonophobia, nausea and emotional control of pain correlate with the clinical response in terms of reduction of these respective symptoms over 3 months; 4. To evaluate whether there are baseline functional MRI markers predictive of good clinical response to erenumab at 3 months.;Primary end point(s): 1. Between-treatment groups difference in change of resting state functional connectivity strength in the brain areas involved in pain processing measured as z-score maps. 2. Change of resting state functional connectivity strength in the areas of interest including pain proc | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Correlation (by treatment groups and in all patients) between the changes in the resting state functional connectivity strength in the regions of interest and a. the percentage of reduction in monthly migraine days b. the reduction in monthly average severity of migraine pain (1-10 scale score included in the diary) c. the percentage of reduction in monthly number of days with use of acute treatments d. the change in HIT-6 score; Between-treatment groups difference in change of resting state functional connectivity strength in the brain regions involved in the following migraine symptoms: a. sensory hypersensitivity (allodynia) b. visual or auditory hypersensitivity (photophobia or phonophobia) c. neurovegetative symptoms (nausea) d. altered emotional control of pain; Correlation (by treatment group and in all patients) between: a. the changes in the resting state functional connectivity strength of the brain regions mediating allodynia and the changes in the Allodynia Symptom Checklist 12 (ASC-12) score at month 3 b. the changes in the resting state functional connectivity strength of the brain regions mediating photophobia and phonophobia and the percentage changes in number of attacks with photophobia and phonophobia at month 3 c. the changes in the resting state functional connectivity strength of the brain regions mediating neurovegetative symptoms and the percentage changes in number of attacks with nausea at month 3 d. the changes in the resting state functional connectivity strength of the brain regions underlying the altered emotional control of pain and the changes in HADS score at month 3; Baseline resting state functional connectivity strength will be evaluated by treatment group and in all patients as potential predictors of treatment clinical response defined by the achievement of at least 50% reduction of monthly migraine days.;Timepoint(s) of evaluation of this end point: a. At month 3 of treatment vs baseline b. At month | — |
Countries
Italy
Contacts
Public ContactDrug Regulatory Affairs
Novartis Farma S.p.A.
Outcome results
None listed