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Trial record 2 of 7 for:    apollon
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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04084314
Recruitment Status : Not yet recruiting
First Posted : September 10, 2019
Last Update Posted : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 560 participants
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
Estimated Study Start Date : September 26, 2019
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : August 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

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


Outcome Measures
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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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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.
Contacts and Locations
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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


Contacts
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Contact: Novartis Pharmaceuticals +41613241111 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals

Sponsors and Collaborators
Novartis Pharmaceuticals
More Information
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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: September 10, 2019
Last Verified: September 2019
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: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
migraine
episodic migraine
headache
erenumab
 AMG334
aimovig
monoclonal antibody
CGRP-receptor antibody
Additional relevant MeSH terms:
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Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
 Erenumab
Antibodies
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Calcitonin Gene-Related Peptide Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents