Recruiting
Sponsor ID
20180125
Aimovig Pregnancy Exposure Registry
Study Details
The primary objective of this study is to estimate the proportion of major congenital malformations in infants of women with migraine exposed to erenumab-aooe during pregnancy compared to infants of women with migraine unexposed to erenumeb-aooe.
Protocol Summary
Primary Outcome Measures
Number of Infants Experiencing Major Congenital Malformations
Timeframe: Up to 52 Weeks
Secondary Outcome Measures
Number of Women with Pregnancy Complications Following Erenumab-aooe Administration
Timeframe: Week 52
Number of Women Experiencing Spontaneous Abortion, Still Birth, Elective Termination, and Preterm Birth
Timeframe: Up to Approximately 38 Weeks
Percentage of Infants of Women Exposed to Erenumab-aooe who are Small-for-gestational age
Timeframe: Up to Approximately 38 Weeks
Percentage of Infants of Women Exposed to Erenumab-aooe Experiencing Minor Congenital Malformations
Timeframe: Up to Week 52
Percentage of Infants of Women Exposed to Erenumab-aooe with Postnatal Growth and Development Deficiency Through the First Year of life
Timeframe: Up to Week 52
Percentage of Participants with Maternal Outcomes
Timeframe: Up to Approximately 38 Weeks
Percentage of Participants with Fetal Outcomes
Timeframe: Up to Approximately 38 Weeks
Percentage of Participants with Infant Outcomes
Timeframe: Up to Week 52
Frequency of Major Congenital Malformations of Women with Migraine Exposed to Erenumab-aooe During Pregnancy with Women Representing the Prevalence of Birth Defects in the General Population (External Comparator)
Timeframe: Up to Week 52
Locations
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