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Status:

COMPLETED

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

Lead Sponsor:

Novartis Pharmaceuticals

Conditions:

Migraine

Migraine Disorders

Eligibility:

All Genders

18-67 years

Phase:

PHASE4

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 (...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    September 30 2019

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    March 13 2023

    Estimated Enrollment :

    701 Patients enrolled

    Trial Details

    Trial ID

    NCT04084314

    Start Date

    September 30 2019

    End Date

    March 13 2023

    Last Update

    October 9 2024

    Active Locations (75)

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    Page 1 of 19 (75 locations)

    1

    Novartis Investigative Site

    Stuttgart, Baden-Wurttemberg, Germany, 70178

    2

    Novartis Investigative Site

    Marburg Wehrda, Germany, Germany, 35041

    3

    Novartis Investigative Site

    Hanover, Lower Saxony, Germany, 30159

    4

    Novartis Investigative Site

    Aachen, North Rhine-Westphalia, Germany, 52062