Assessment of Prolonged Safety and tOLerability of in Migraine Patients in a Long-term OpeN-label Study (APOLLON)
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| ClinicalTrials.gov Identifier: NCT04084314 |
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Recruitment Status :
Active, not recruiting
First Posted : September 10, 2019
Last Update Posted : January 17, 2023
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Migraine Migraine Disorders Migraine Headache | Biological: Erenumab | Phase 4 |
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 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 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Erenumab
70 mg and 140 mg Erenumab
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Biological: Erenumab
pre-filled pen (auto-injector)
Other Name: AMG334; Aimovig |
- 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
- 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
- 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.
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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.
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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| 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 |
| 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 |
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migraine episodic migraine headache erenumab |
AMG334 aimovig monoclonal antibody CGRP-receptor antibody |
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Migraine Disorders Headache Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Pain |
Neurologic Manifestations Erenumab Calcitonin Gene-Related Peptide Receptor Antagonists Molecular Mechanisms of Pharmacological Action Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |