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

NCT ID: NCT03977649

Last Updated: 2021-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-30
• Study Completion Date: 2021-07-05

Brief Summary

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

Detailed Description

This is a randomized, double blind, placebo-controlled trial with a 2-sequence, 2-period, 2-treatment crossover design. The study population will consist of adult male and female subjects with a documented history of episodic migraine (4 to 14 baseline migraine days), who have failed at least 2 previous migraine prophylactic treatment for lack of efficacy or tolerability. After a run-in phase of 4 weeks, patients will be randomized, according to a 1:1 ratio, to a 24 weeks of treatment, as follow:

• Sequence 1: A/B
• Sequence 2: B/A where: A=monthly subcutaneous erenumab 140 mg for 12 weeks; B=monthly subcutaneous masked placebo for 12 weeks

Conditions

Migraine Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

erenumab

monthly subcutaneous erenumab 140 mg for 12 weeks

Group Type: EXPERIMENTAL

erenumab

Intervention Type: DRUG

erenumab 140 mg sc every 4 weeks

placebo

monthly subcutaneous masked placebo for 12 weeks.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

placebo sc every 4 weeks

Interventions

erenumab

erenumab 140 mg sc every 4 weeks

Intervention Type: DRUG

placebo

placebo sc every 4 weeks

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Novartis Investigative Site

Milan, MI, Italy

Novartis Investigative Site

Milan, MI, Italy

Novartis Investigative Site

Pavia, PV, Italy

Novartis Investigative Site

L’Aquila, , Italy

Novartis Investigative Site

Napoli, , Italy

Countries

Italy

Other Identifiers

CAMG334AIT03

Identifier Type: -

Identifier Source: org_study_id