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

Phase 4

Completed

• Conditions: Migraine Headache; Migraine; Migraine Disorders
• Interventions: Biological: Erenumab

• Registration Number: NCT04084314
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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.

Study Timeline

• Study First Submitted: 2019-09-06
• Study First Submitted QC: 2019-09-06
• Study First Posted: 2019-09-10
• Study Start: 2019-09-30
• Primary Completion: 2023-02-23
• Study Completion: 2023-03-13
• Results First Submitted: 2024-01-10
• Results First Submitted QC: 2024-01-10
• Results First Posted: 2024-02-06
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 701

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Erenumab	Erenumab	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.

Primary Outcome Measures

Name	Time	Method
Exposure Adjusted Incidence Rate of AE During Open-label Treatment Epoch Per 100 Subject Years	Up to 128 weeks	This outcome measure was calculated dividing the number of adverse events (AEs) by the total patient exposure time and standardizing it per 100 patient-years. Exact Pearson-Clopper confidence intervals for single proportions were calculated to evaluate the precision of the estimated parameter.

Secondary Outcome Measures

Name	Time	Method
Proportion of Patients Discontinuing Open-label Treatment Epoch Due to AE	Up to 128 weeks	Participants discontinuing the Open-label Treatment Epoch due to adverse events (AEs) to evaluate the long-term tolerability of erenumab in patients with episodic migraine or chronic migraine.
Proportion of Patients Discontinuing Open-label Treatment Epoch Due to Non-AE Reasons	Up to 128 weeks	Participants discontinuing the Open-label Treatment Epoch due to non-AE reasons to evaluate the long-term tolerability of erenumab in patients with episodic migraine or chronic migraine.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇩🇪 Wuerzburg, Germany