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NCT Number: NCT04084314

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

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Headache Disorders Headache Disorders, Primary Migraine Disorders Migraine Headache Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–67 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site, Stuttgart, Baden-Wurttemberg, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Erenumab

Biological

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

Other names: AMG334; Aimovig

Primary outcomes

  1. Exposure Adjusted Incidence Rate of AE During Open-label Treatment Epoch Per 100 Subject Years

    Time frame: Up to 128 weeks

    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.

Secondary outcomes

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

    Time frame: Up to 128 weeks

    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.

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

    Time frame: Up to 128 weeks

    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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Acronym: APOLLON

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Sep 10, 2019
Registry last updated
Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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