Study of Efficacy and Safety of Erenumab in Adult Chronic Migraine Patients
Phase 3
Active, not recruiting
- Conditions
- Migraine
- Interventions
- Other: PlaceboBiological: Erenumab
- Registration Number
- NCT03867201
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety of erenumab in patients with chronic migraine in Asian population.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 557
Inclusion Criteria
Not provided
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Exclusion Criteria
Not provided
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Administered by pre-filled syringe Erenumab Erenumab Administered by pre-filled syringe
- Primary Outcome Measures
Name Time Method Change from baseline in monthly migraine days during the last 4 weeks of the 12-week treatment period 12 weeks
- Secondary Outcome Measures
Name Time Method Number of subjects with adverse events as a measure of safety through study completion, an average of 20 weeks Achievement of at least a 50% reduction from baseline in monthly migraine days during the last 4 weeks of the 12-week treatment period 12 weeks Change from baseline in monthly acute headache medication days during the last 4 weeks of the 12-week treatment period 12 weeks Number of subjects with anti-AMG 334 antibodies (binding and if positive, neutralizing) Day1, Week 12, Week 20 Change from baseline in migraine-related disability and productivity as measured by the mMIDAS during the last 4 weeks of the 12-week treatment period 12 weeks
Trial Locations
- Locations (1)
Novartis Investigative Site
🇻🇳Hanoi, Vietnam