Assessment of Prolonged Safety and tOLerability of in Migraine Patients in a Long-term OpeN-label Study
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 560
Summary
- Conditions
- Migraine
- Migraine Disorders
- Migraine Headache
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 60 years
- Gender
- Both males and females
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 ...
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.
Tracking Information
- NCT #
- NCT04084314
- Collaborators
- Not Provided
- Investigators
- Not Provided
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