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

Migraine Clinical Trial

— APOLLON  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04084314
• Other study ID #: CAMG334ADE03
• Secondary ID: 2019-002201-22
• Status: Completed
• Phase: Phase 4
• Start date: September 30, 2019
• Est. completion date: March 13, 2023

Study information

• Verified date: January 2024
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 701
• Est. completion date: March 13, 2023
• Est. primary completion date: February 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 67 Years

Eligibility

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.

Related Conditions & MeSH terms

• Headache
• Migraine
• Migraine Disorders
• Migraine Headache

Intervention

Biological:
• Erenumab
Erenumab was supplied as a pre-filled pen (auto-injector) for subcutaneous injection.

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Aachen	Nordrhein-Westfalen
Germany	Novartis Investigative Site	Alzenau
Germany	Novartis Investigative Site	Bad Homburg
Germany	Novartis Investigative Site	Bad Honnef
Germany	Novartis Investigative Site	Bad Saarow
Germany	Novartis Investigative Site	Bayreuth
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Bielefeld
Germany	Novartis Investigative Site	Boblingen
Germany	Novartis Investigative Site	Bochum
Germany	Novartis Investigative Site	Bonn
Germany	Novartis Investigative Site	Bonn
Germany	Novartis Investigative Site	Chemnitz
Germany	Novartis Investigative Site	Dillingen
Germany	Novartis Investigative Site	Erbach
Germany	Novartis Investigative Site	Essen
Germany	Novartis Investigative Site	Essen
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Freiburg
Germany	Novartis Investigative Site	Gelsenkirchen
Germany	Novartis Investigative Site	Greifswald
Germany	Novartis Investigative Site	Haar
Germany	Novartis Investigative Site	Halle
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hannover	Niedersachsen
Germany	Novartis Investigative Site	Heidelberg
Germany	Novartis Investigative Site	Hoppegarten
Germany	Novartis Investigative Site	Ibbenbueren
Germany	Novartis Investigative Site	Jena
Germany	Novartis Investigative Site	Juelich
Germany	Novartis Investigative Site	Kassel
Germany	Novartis Investigative Site	Kiel
Germany	Novartis Investigative Site	Koln
Germany	Novartis Investigative Site	Königstein im Taunus
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Luenen
Germany	Novartis Investigative Site	Mannheim
Germany	Novartis Investigative Site	Marburg Wehrda
Germany	Novartis Investigative Site	Mittweida
Germany	Novartis Investigative Site	Muenchen
Germany	Novartis Investigative Site	Muenchen
Germany	Novartis Investigative Site	Muenster
Germany	Novartis Investigative Site	Neu-Ulm
Germany	Novartis Investigative Site	Neuburg an der Donau
Germany	Novartis Investigative Site	Osnabrück
Germany	Novartis Investigative Site	Pforzheim
Germany	Novartis Investigative Site	Quakenbrueck
Germany	Novartis Investigative Site	Regensburg
Germany	Novartis Investigative Site	Rostock
Germany	Novartis Investigative Site	Ruelzheim
Germany	Novartis Investigative Site	Schwerin
Germany	Novartis Investigative Site	Schwerin
Germany	Novartis Investigative Site	Seesen
Germany	Novartis Investigative Site	Siegen
Germany	Novartis Investigative Site	Sindelfingen
Germany	Novartis Investigative Site	Stadtroda
Germany	Novartis Investigative Site	Stuttgart
Germany	Novartis Investigative Site	Stuttgart
Germany	Novartis Investigative Site	Stuttgart
Germany	Novartis Investigative Site	Stuttgart	Baden Wuertemberg
Germany	Novartis Investigative Site	Trier
Germany	Novartis Investigative Site	Tuebingen
Germany	Novartis Investigative Site	Ulm
Germany	Novartis Investigative Site	Unterhaching
Germany	Novartis Investigative Site	Westerstede Oldenburg
Germany	Novartis Investigative Site	Wiesbaden
Germany	Novartis Investigative Site	Wuerzburg

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exposure Adjusted Incidence Rate of AE During Open-label Treatment Epoch Per 100 Subject Years	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.	Up to 128 weeks
Secondary	Proportion of Patients Discontinuing Open-label Treatment Epoch Due to AE	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.	Up to 128 weeks
Secondary	Proportion of Patients Discontinuing Open-label Treatment Epoch Due to Non-AE Reasons	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.	Up to 128 weeks