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Trial record 2 of 7 for:    apollon

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04084314
Recruitment Status : Active, not recruiting
First Posted : September 10, 2019
Last Update Posted : January 17, 2023
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This is a 128-week open-label study to assess the long-term safety and tolerabilty of the monoclonal antibody erenumab.

Condition or disease Intervention/treatment Phase
Migraine Migraine Disorders Migraine Headache Biological: Erenumab Phase 4

Detailed Description:

The regular assessments in a controlled trial allows a close observation of safety parameters during long-term treatment with erenumab. This 128-week open-label study will provide further treatment to patients of the study CAMG334ADE01 (Eudract number:2019-002201-22) and will provide data about the long-term safety and tolerability of erenumab and patients' quality of life during long-term treatment.

Besides options to adjust the dose, an optional drug holiday is included in this open-label study and the effects of a treatment interruption on safety, tolerability, efficacy and quality of life will be investigated.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 700 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Assessment of Prolonged Safety and tOLerability of in Migraine Patients in a Long-term OpeN-label Study
Actual Study Start Date : September 30, 2019
Estimated Primary Completion Date : March 13, 2023
Estimated Study Completion Date : March 13, 2023

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine
Drug Information available for: Erenumab

Arm Intervention/treatment
Experimental: Erenumab
70 mg and 140 mg Erenumab
Biological: Erenumab
pre-filled pen (auto-injector)
Other Name: AMG334; Aimovig

Primary Outcome Measures :
  1. Exposure adjusted incidence rate of AE during Open-label Treatment Epoch per 100 subject years [ Time Frame: 128 weeks ]
    To evaluate the long-term safety of 70 and 140 mg erenumab

Secondary Outcome Measures :
  1. Proportion of patients discontinuing open-label Treatment Epoch due to AE [ Time Frame: 128 weeks ]
    To evaluate the long-term tolerability of 70 and 140 mg erenumab

  2. Proportion of patients discontinuing open-label Treatment Epoch due to non-AE reasons [ Time Frame: 128 weeks ]
    To evaluate the long-term tolerability of 70 and 140 mg erenumab in patients with episodic migraine.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04084314

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Sponsors and Collaborators
Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04084314    
Other Study ID Numbers: CAMG334ADE03
First Posted: September 10, 2019    Key Record Dates
Last Update Posted: January 17, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
episodic migraine
monoclonal antibody
CGRP-receptor antibody
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Calcitonin Gene-Related Peptide Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs