Assessment of Prolonged Safety and tOLerability of in Migraine Patients in a Long-term OpeN-label Study
CompletedPhase 4NCT04084314
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
This is a 128-week open-label study to assess the long-term safety and tolerabilty of the monoclonal antibody erenumab in migraine patients.
Study details
- Official title
- Assessment of Prolonged Safety and tOLerability of in Migraine Patients in a Long-term OpeN-label Study
- Conditions
- Migraine
- Migraine Disorders
- Migraine Headache
- Interventions
- Sponsor
- Novartis Pharmaceuticals
- Organization
- Novartis
- Start date
- 2019-09-30
- Primary completion
- 2023-02-23
- Sex
- All
- Age range
- from 18 Years to 67 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- Germany
- Total sites listed
- 75
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04084314