Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT01026077 |
| Other study ID # |
MLN-MD-30 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 2009 |
| Est. completion date |
June 2025 |
Study information
| Verified date |
November 2023 |
| Source |
Syneos Health |
| Contact |
Savella Pregnancy Registry associate |
| Phone |
877-643-3010 |
| Email |
pregnancyregistries[@]syneoshealth.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
The Savella Pregnancy Registry is a US based registry designed to monitor pregnancies exposed
to Savella (milnacipran HCI). This is an observational, exposure-registration and follow-up
registry designed primarily to estimate the prevalence of major congenital anomalies, and
secondarily to estimate the prevalence of recognized spontaneous abortions, stillbirths,
induced abortions, minor congenital anomalies, and any serious adverse pregnancy outcomes
among pregnancies exposed to Savella as well as adverse outcomes observed during the first
year of life in off-springs born from these exposed pregnancies. Live offspring are followed
from birth until age one. The Savella Pregnancy Registry is sponsored by AbbVie (formerly
Actavis PLC, Forest Laboratories Inc., and Allergan) and managed by Syneos Health.
Description:
Registry enrollment is voluntary and initiated by pregnant patients or their healthcare
providers (HCP). Patient-initiated reports must be verified by the HCP. Enrollment should
occur as early in pregnancy as possible, preferably before any prenatal testing has occurred;
however, enrollment at any time during pregnancy is allowed. Near the estimated date of
delivery, the Registry prompts the HCP to provide pregnancy outcome data. If a live birth is
reported, the Registry conducts follow-up with the infant's HCP at outcome, 4 months, and 12
months of age. If a birth defect is indicated, the Registry requests additional targeted
follow-up information from the HCP. Data are collected on exposure to Savella, potential
confounding factors, pregnancy outcome, and pediatric outcome for all live born babies. Cases
are reviewed and classified according to type of birth defects. Adverse event cases are
forwarded to Allergan.
