NCT04084314

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 701 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 67 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Migraine
• Migraine Disorders
• Migraine Headache

Interventions

Type	Name	Description
BIOLOGICAL	Erenumab	Erenumab was supplied as a pre-filled pen (auto-injector) for subcutaneous injection.

Timeline

• Start date: 2019-09-30
• Primary completion: 2023-02-23
• Completion: 2023-03-13
• First posted: 2019-09-10
• Last updated: 2024-10-09
• Results posted: 2024-02-06

Locations

75 sites across 1 country: Germany

Regulatory

• FDA-regulated drug study