Phase 4
N=701
Assessment of Prolonged Safety and tOLerability of in Migraine Patients in a Long-term OpeN-label Study
Migraine · Migraine Disorders · Migraine Headache
Bottom Line
View on ClinicalTrials.gov: NCT04084314 ↗Enrolled (actual)
701
Serious AEs
12.3%
Results posted
Feb 2024
Primary outcome: Primary: Exposure Adjusted Incidence Rate of AE During Open-label Treatment Epoch Per 100 Subject Years — 101.71 number of AEs per 100 patient-years
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Erenumab (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Exposure Adjusted Incidence Rate of AE During Open-label Treatment Epoch Per 100 Subject Years |
101.71 | — |
| SECONDARY Proportion of Patients Discontinuing Open-label Treatment Epoch Due to AE |
29 | — |
| SECONDARY Proportion of Patients Discontinuing Open-label Treatment Epoch Due to Non-AE Reasons |
126 | — |
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.
Eligibility Criteria
The study population consisted of patients with a documented history of episodic (4 - 14 baseline migraine days) or chronic migraine (≥15 baseline headache days), who had been successfully randomized to clinical trial CAMG334ADE01.
Key inclusion Criteria
- Signed informed consent must be obtained prior to participation in the study
- Patient is capable of understanding the nature, significance and implications of the clinical trial.
- Adults ≥18 years of age upon entry into screening
Key exclusion Criteria
- Use of a prophylactic migraine medication within five plasma clearance half-lives, or a device or procedure within one month prior to the start of the Open-label Treatment Epoch. This exclusion criteria does not apply to erenumab or topiramate administered within clinical trial CAMG334ADE01
- Any prior exposure to (investigational) prophylactic migraine products targeting the CGRP pathway, other than erenumab.
Data sourced from ClinicalTrials.gov (NCT04084314). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.