A Functional MRI Study on Erenumab Treatment Effects in Episodic Migraine Patients (NCT03977649) | Clinical Trial Compass
CompletedPhase 4
A Functional MRI Study on Erenumab Treatment Effects in Episodic Migraine Patients
Italy62 participantsStarted 2019-07-30
Plain-language summary
The purpose of this study is to investigate the effects of erenumab on central sensitization and brain networks connectivity of migraine patients
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Signed informed consent must be obtained prior to participation in the study History of migraine with or without aura for at least 12 months prior to screening 4. Migraine frequency: ≥ 4 and \< 15 migraine days per month on average across the 3 months prior to screening and confirmed during the baseline phase based on diary calculation
* Headache frequency: \<15 headache days per month on average across the 3 months prior to screening and confirmed during the baseline phase based on diary calculation
* Failure to 2 or more previous treatment categories locally indicated for migraine prophylaxis due to either lack of efficacy or poor tolerability
Exclusion Criteria:
* History of cluster headache or hemiplegic migraine headache
* History of chronic pain disorders and neuropathic pain
* History of head trauma or seizure or major psychiatric disorders or suicidal ideation/behavior at any time before screening
* Currently, receiving 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), or less than 60 days or 5 half-lives prior to the start of the baseline period, during the baseline period, or treatment period
* Exposure to botulinum toxin in the head and/or neck region within 4 months prior to the start of the baseline period, during the baseline period, or treatment period.
* Taken the following fo…