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

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

Detailed Description
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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.

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

Conditions
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Migraine, Migraine Disorders, Migraine Headache

Intervention / Treatment
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* Biological: Erenumab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Erenumab<br>70 mg and 140 mg Erenumab | Biological: Erenumab<br>* pre-filled pen (auto-injector)<br>* Other names: AMG334; Aimovig;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exposure adjusted incidence rate of AE during Open-label Treatment Epoch per 100 subject years | To evaluate the long-term safety of 70 and 140 mg erenumab | 128 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CGRP-receptor antibody, migraine, episodic migraine, headache, erenumab, AMG334, aimovig, monoclonal antibody