NCT03977649

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

A RandomizEd, Double-blind, Cross-over Study to Assess Erenumab effecT on BRAIN Networks Function and Structure in Comparison to Placebo in Episodic Migraine Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	erenumab	erenumab 140 mg sc every 4 weeks
DRUG	placebo	placebo sc every 4 weeks

Timeline

• Start date: 2019-07-30
• Primary completion: 2021-07-05
• Completion: 2021-07-05
• First posted: 2019-06-06
• Last updated: 2021-08-13

Locations

5 sites across 1 country: Italy

Regulatory

• FDA-regulated drug study