Assessment of Prolonged Safety and tOLerability of in Migraine Patients in a Long-term OpeN-label… (NCT04084314) | Clinical Trial Compass
CompletedPhase 4
Assessment of Prolonged Safety and tOLerability of in Migraine Patients in a Long-term OpeN-label Study
Germany701 participantsStarted 2019-09-30
Plain-language 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.
Who can participate
Age range18 Years – 67 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Exposure Adjusted Incidence Rate of AE During Open-label Treatment Epoch Per 100 Subject Years