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MigrainePhase 4APOLLONNCT04084314

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

A Phase 4 study testing Erenumab in people with Migraine and Migraine Disorders, run by Novartis Pharmaceuticals at 75 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 67 years
Conditions the study is for
Migraine, Migraine Disorders, Migraine Headache
What is being tested?
Erenumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
701 participants
Where
75 sitesGermany
Study dates
30 Sep 2019to 13 Mar 2023
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 67 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

75 sites in 1 country.

75 sites in 1 country

Germany75 sites

  • Novartis Investigative Site

    Aachen, North Rhine-Westphalia, 52062

  • Novartis Investigative Site

    Alzenau in Unterfranken, 63755

  • Novartis Investigative Site

    Bad Homburg, 61348

  • Novartis Investigative Site

    Bad Honnef, 53604

  • Novartis Investigative Site

    Bad Saarow, 15526

  • Novartis Investigative Site

    Bayreuth, 95445

  • Novartis Investigative Site

    Berlin, 10713

  • Novartis Investigative Site

    Berlin, 120999

  • Novartis Investigative Site

    Berlin, 12101

  • Novartis Investigative Site

    Berlin, 12163

  • Novartis Investigative Site

    Berlin, 12627

  • Novartis Investigative Site

    Berlin, 13053

  • Novartis Investigative Site

    Berlin, 13353

  • Novartis Investigative Site

    Berlin, 14169

  • Novartis Investigative Site

    Bielefeld, D 33647

  • Novartis Investigative Site

    Böblingen, 71032

  • Novartis Investigative Site

    Bochum, 44791

  • Novartis Investigative Site

    Bonn, 53111

  • Novartis Investigative Site

    Bonn, 53177

  • Novartis Investigative Site

    Chemnitz, 09117

  • Novartis Investigative Site

    Cologne, 50935

  • Novartis Investigative Site

    Dillingen, 66763

  • Novartis Investigative Site

    Erbach im Odenwald, 64711

  • Novartis Investigative Site

    Essen, 45133

  • Novartis Investigative Site

    Essen, 45147

  • Novartis Investigative Site

    Frankfurt, 60313

  • Novartis Investigative Site

    Freiburg im Breisgau, 79098

  • Novartis Investigative Site

    Gelsenkirchen, 45879

  • Novartis Investigative Site

    Greifswald, 17475

  • Novartis Investigative Site

    Haar, 85540

  • Novartis Investigative Site

    Halle, 06120

  • Novartis Investigative Site

    Hamburg, 20253

  • Novartis Investigative Site

    Hanover, Lower Saxony, 30159

  • Novartis Investigative Site

    Heidelberg, 69120

  • Novartis Investigative Site

    Hoppegarten, 15366

  • Novartis Investigative Site

    Ibbenbueren, 49477

  • Novartis Investigative Site

    Jena, 07740

  • Novartis Investigative Site

    Jülich, 52428

  • Novartis Investigative Site

    Kassel, 34121

  • Novartis Investigative Site

    Kiel, 24149

  • Novartis Investigative Site

    Königstein im Taunus, 61462

  • Novartis Investigative Site

    Leipzig, 04103

  • Novartis Investigative Site

    Leipzig, 04107

  • Novartis Investigative Site

    Lünen, 44534

  • Novartis Investigative Site

    Mannheim, 66163

  • Novartis Investigative Site

    Marburg Wehrda, Germany, 35041

  • Novartis Investigative Site

    Mittweida, 09648

  • Novartis Investigative Site

    München, 81377

  • Novartis Investigative Site

    München, 81675

  • Novartis Investigative Site

    Münster, 48149

  • Novartis Investigative Site

    Neu-Ulm, 89231

  • Novartis Investigative Site

    Neuburg an der Donau, 86633

  • Novartis Investigative Site

    Osnabrück, 49074

  • Novartis Investigative Site

    Pforzheim, 75172

  • Novartis Investigative Site

    Quakenbrück, 49610

  • Novartis Investigative Site

    Regensburg, 93059

  • Novartis Investigative Site

    Rostock, 18057

  • Novartis Investigative Site

    Rülzheim, 76761

  • Novartis Investigative Site

    Schwerin, 19053

  • Novartis Investigative Site

    Schwerin, 19055

  • Novartis Investigative Site

    Seesen, 38723

  • Novartis Investigative Site

    Siegen, 57076

  • Novartis Investigative Site

    Sindelfingen, 71065

  • Novartis Investigative Site

    Stadtroda, 07646

  • Novartis Investigative Site

    Stuttgart, Baden-Wurttemberg, 70178

  • Novartis Investigative Site

    Stuttgart, 70174

  • Novartis Investigative Site

    Stuttgart, 70178

  • Novartis Investigative Site

    Stuttgart, 70182

  • Novartis Investigative Site

    Trier, 54292

  • Novartis Investigative Site

    Tübingen, 72076

  • Novartis Investigative Site

    Ulm, 89073

  • Novartis Investigative Site

    Unterhaching, 82008

  • Novartis Investigative Site

    Westerstede Oldenburg, 26655

  • Novartis Investigative Site

    Wiesbaden, 65191

  • Novartis Investigative Site

    Würzburg, 97080

Other trials in Germany

About this study

This is a 128-week open-label study to assess the long-term safety and tolerabilty of the monoclonal antibody erenumab in migraine patients.

Read the 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 (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.
Being tested
Erenumab
Keywords
migraine, episodic migraine, chronic migraine, headache, erenumab, AMG334, aimovig, monoclonal antibody, CGRP-receptor antibody
Medical subject headings
Migraine Disorders, Headache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ErenumabBiological

    Also called AMG334; Aimovig

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

Study groups in NCT04084314
Study groupRoleWhat they receive
ErenumabExperimentalErenumab dose could be adjusted from 70 mg to 140 mg or vice versa at the discretion of the physician at any scheduled study visit.
Receives: Biological: Erenumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 128 weeks

Secondary outcomes (2)

  1. 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.

    Measured: Up to 128 weeks

  2. 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.

    Measured: Up to 128 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2019
  2. Study start30 Sep 2019
  3. Primary completion23 Feb 2023
  4. Study completion13 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
701 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04084314
Sponsor's protocol ID
CAMG334ADE03
Other IDs
2019-002201-22, 2019
Acronym
APOLLON
Status last verified
Oct 2024
First submitted
6 Sep 2019
Last updated
9 Oct 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • 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.

    PubMed 39322961

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Erenumab in people with Migraine and Migraine Disorders, run by Novartis Pharmaceuticals at 75 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 75 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Exposure Adjusted Incidence Rate of AE During Open-label Treatment Epoch Per 100 Subject Years (time frame: Up to 128 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04084314, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024.

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