A Functional MRI Study on Erenumab Treatment Effects in Episodic Migraine Patients

• Status: Completed
• Trial end date: 2021-07-05
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the effects of erenumab on central sensitization and brain networks connectivity of migraine patients

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Antibodies, Monoclonal; Erenumab

Criteria

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 for any indication in any month during the 2 months prior to the start of the baseline period:

• Ergotamines or triptans on ≥ 10 days per month, or

• Simple analgesics (non-steroidal anti-inflammatory drugs [NSAIDs], acetaminophen) on ≥ 15 days per month, or

• Opioid- or butalbital-containing analgesics on ≥4 days per month.

• Previous exposure to erenumab or exposure to any other prophylactic CGRP-targeted therapy (prior to and during the study)

• History or evidence of any other unstable or clinically significant medical condition that in the opinion of the investigator would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion

• Subject has any clinically significant vital sign, laboratory, or electrocardiogram (ECG) abnormality during screening that, in the opinion of the investigator, could pose a risk to subject safety or interfere with the study evaluation

• Evidence of drug or alcohol abuse or dependence within 12 months prior to screening, based on medical records or patient self-report

• Pregnant or breastfeeding

• All the clinical conditions for which undergoing an MRI scan is contraindicated