NCT04084314

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
701

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2019

Longer than P75 for phase_4

Geographic Reach
1 country

75 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 10, 2019

Completed
20 days until next milestone

Study Start

First participant enrolled

September 30, 2019

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2023

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2023

Completed
11 months until next milestone

Results Posted

Study results publicly available

February 6, 2024

Completed
Last Updated

October 9, 2024

Status Verified

October 1, 2024

Enrollment Period

3.4 years

First QC Date

September 6, 2019

Results QC Date

January 10, 2024

Last Update Submit

October 7, 2024

Conditions

MigraineMigraine DisordersMigraine Headache

Keywords

migraineepisodic migrainechronic migraineheadacheerenumabAMG334aimovigmonoclonal antibodyCGRP-receptor antibody

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Proportion of Patients Discontinuing Open-label Treatment Epoch Due to AE

    Up to 128 weeks

  • Proportion of Patients Discontinuing Open-label Treatment Epoch Due to Non-AE Reasons

    Up to 128 weeks

Study Arms (1)

Erenumab

EXPERIMENTAL

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.

Biological: Erenumab

Interventions

ErenumabBIOLOGICAL

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

Also known as: AMG334; Aimovig
Erenumab

Eligibility Criteria

Age18 Years - 67 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Any prior exposure to (investigational) prophylactic migraine products targeting the CGRP pathway, other than erenumab.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (75)

Novartis Investigative Site

Stuttgart, Baden-Wurttemberg, 70178, Germany

Location

Novartis Investigative Site

Marburg Wehrda, Germany, 35041, Germany

Location

Novartis Investigative Site

Hanover, Lower Saxony, 30159, Germany

Location

Novartis Investigative Site

Aachen, North Rhine-Westphalia, 52062, Germany

Location

Novartis Investigative Site

Alzenau in Unterfranken, 63755, Germany

Location

Novartis Investigative Site

Bad Homburg, 61348, Germany

Location

Novartis Investigative Site

Bad Honnef, 53604, Germany

Location

Novartis Investigative Site

Bad Saarow, 15526, Germany

Location

Novartis Investigative Site

Bayreuth, 95445, Germany

Location

Novartis Investigative Site

Berlin, 10713, Germany

Location

Novartis Investigative Site

Berlin, 120999, Germany

Location

Novartis Investigative Site

Berlin, 12101, Germany

Location

Novartis Investigative Site

Berlin, 12163, Germany

Location

Novartis Investigative Site

Berlin, 12627, Germany

Location

Novartis Investigative Site

Berlin, 13053, Germany

Location

Novartis Investigative Site

Berlin, 13353, Germany

Location

Novartis Investigative Site

Berlin, 14169, Germany

Location

Novartis Investigative Site

Bielefeld, D 33647, Germany

Location

Novartis Investigative Site

Bochum, 44791, Germany

Location

Novartis Investigative Site

Bonn, 53111, Germany

Location

Novartis Investigative Site

Bonn, 53177, Germany

Location

Novartis Investigative Site

Böblingen, 71032, Germany

Location

Novartis Investigative Site

Chemnitz, 09117, Germany

Location

Novartis Investigative Site

Cologne, 50935, Germany

Location

Novartis Investigative Site

Dillingen, 66763, Germany

Location

Novartis Investigative Site

Erbach im Odenwald, 64711, Germany

Location

Novartis Investigative Site

Essen, 45133, Germany

Location

Novartis Investigative Site

Essen, 45147, Germany

Location

Novartis Investigative Site

Frankfurt, 60313, Germany

Location

Novartis Investigative Site

Freiburg im Breisgau, 79098, Germany

Location

Novartis Investigative Site

Gelsenkirchen, 45879, Germany

Location

Novartis Investigative Site

Greifswald, 17475, Germany

Location

Novartis Investigative Site

Haar, 85540, Germany

Location

Novartis Investigative Site

Halle, 06120, Germany

Location

Novartis Investigative Site

Hamburg, 20253, Germany

Location

Novartis Investigative Site

Heidelberg, 69120, Germany

Location

Novartis Investigative Site

Hoppegarten, 15366, Germany

Location

Novartis Investigative Site

Ibbenbueren, 49477, Germany

Location

Novartis Investigative Site

Jena, 07740, Germany

Location

Novartis Investigative Site

Jülich, 52428, Germany

Location

Novartis Investigative Site

Kassel, 34121, Germany

Location

Novartis Investigative Site

Kiel, 24149, Germany

Location

Novartis Investigative Site

Königstein im Taunus, 61462, Germany

Location

Novartis Investigative Site

Leipzig, 04103, Germany

Location

Novartis Investigative Site

Leipzig, 04107, Germany

Location

Novartis Investigative Site

Lünen, 44534, Germany

Location

Novartis Investigative Site

Mannheim, 66163, Germany

Location

Novartis Investigative Site

Mittweida, 09648, Germany

Location

Novartis Investigative Site

München, 81377, Germany

Location

Novartis Investigative Site

München, 81675, Germany

Location

Novartis Investigative Site

Münster, 48149, Germany

Location

Novartis Investigative Site

Neu-Ulm, 89231, Germany

Location

Novartis Investigative Site

Neuburg an der Donau, 86633, Germany

Location

Novartis Investigative Site

Osnabrück, 49074, Germany

Location

Novartis Investigative Site

Pforzheim, 75172, Germany

Location

Novartis Investigative Site

Quakenbrück, 49610, Germany

Location

Novartis Investigative Site

Regensburg, 93059, Germany

Location

Novartis Investigative Site

Rostock, 18057, Germany

Location

Novartis Investigative Site

Rülzheim, 76761, Germany

Location

Novartis Investigative Site

Schwerin, 19053, Germany

Location

Novartis Investigative Site

Schwerin, 19055, Germany

Location

Novartis Investigative Site

Seesen, 38723, Germany

Location

Novartis Investigative Site

Siegen, 57076, Germany

Location

Novartis Investigative Site

Sindelfingen, 71065, Germany

Location

Novartis Investigative Site

Stadtroda, 07646, Germany

Location

Novartis Investigative Site

Stuttgart, 70174, Germany

Location

Novartis Investigative Site

Stuttgart, 70178, Germany

Location

Novartis Investigative Site

Stuttgart, 70182, Germany

Location

Novartis Investigative Site

Trier, 54292, Germany

Location

Novartis Investigative Site

Tübingen, 72076, Germany

Location

Novartis Investigative Site

Ulm, 89073, Germany

Location

Novartis Investigative Site

Unterhaching, 82008, Germany

Location

Novartis Investigative Site

Westerstede Oldenburg, 26655, Germany

Location

Novartis Investigative Site

Wiesbaden, 65191, Germany

Location

Novartis Investigative Site

Würzburg, 97080, Germany

Location

Related Publications (1)

  • Gobel H, Schlegel E, Jaeger K, Ortler S, Leist L. Assessment of prolonged safety and tolerability of erenumab in migraine patients in a long-term open-label study (APOLLON). J Headache Pain. 2024 Sep 25;25(1):157. doi: 10.1186/s10194-024-01860-w.

    PMID: 39322961DERIVED

Related Links

MeSH Terms

Conditions

Migraine DisordersHeadache

Interventions

erenumab

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
Novartis.email@novartis.com
862-778-8300

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2019

First Posted

September 10, 2019

Study Start

September 30, 2019

Primary Completion

February 23, 2023

Study Completion

March 13, 2023

Last Updated

October 9, 2024

Results First Posted

February 6, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Locations

DE(75)