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|
Recruitment Status : Not yet recruiting
First Posted : September 10, 2019
Last Update Posted : September 10, 2019
|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)|
|Estimated Enrollment :||560 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
70 mg and 140 mg 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.
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
|Contact: Novartis Pharmaceuticalsfirstname.lastname@example.org|
|Contact: Novartis Pharmaceuticals|