Assessment of Prolonged Safety and tOLerability of in Migraine Patients in a Long-term OpeN-label Study — APOLLON  

Migraine Clinical Trial

Official title: Assessment of Prolonged Safety and tOLerability of in Migraine Patients in a Long-term OpeN-label Study

Status Completed

Clinical Trial Summary

This is a 128-week open-label study to assess the long-term safety and tolerabilty of the monoclonal antibody erenumab in migraine patients.

Clinical Trial Description

This was an open-label, multi-center, single arm study with flexible dosing allowing both dose adjustment and one drug holiday per patient.

The study design consisted of 3 parts:

• Screening Epoch (0 - 2 weeks): required for all patients to assess initial eligibility. Eligible patients came from study CAMG334ADE01 (NCT03828539).

• Open-label Treatment Epoch (128 weeks): Individual patients were treated for 128 weeks. In this open-label treatment phase, the erenumab dose could be adjusted from 70 mg to 140 mg or vice versa at the discretion of the physician at any scheduled study visit. Additionally, a voluntary single treatment interruption ('drug holiday') of up to 24 weeks (approximately six months) could be introduced after at least 12 weeks of treatment in the open-label Treatment Epoch.

• Follow-up Epoch (4 weeks): A Follow-Up Visit 4 weeks after the last regular study visit (8 weeks after last investigational medicinal product [IMP] application) was required as part of routine safety monitoring. ;

Related Conditions & MeSH terms

• Headache
• Migraine
• Migraine Disorders
• Migraine Headache

• NCT number: NCT04084314
• Study type: Interventional
• Source: Novartis
• Status: Completed
• Phase: Phase 4
• Start date: September 30, 2019
• Completion date: March 13, 2023