The Savella Pregnancy Registry (SPR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by INC Research
Actavis Inc.
Information provided by (Responsible Party):
INC Research Identifier:
First received: December 3, 2009
Last updated: December 15, 2015
Last verified: December 2015
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 Actavis plc (formerly Forest Laboratories Inc.) and managed by INC Research, LLC.


Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: The Savella Pregnancy Registry

Resource links provided by NLM:

Further study details as provided by INC Research:

Primary Outcome Measures:
  • The primary objective is to estimate the prevalence of major congenital anomalies among off-springs of women exposed to Savella during pregnancy. [ Time Frame: January 2017 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Estimate the prevalence of spontaneous abortions, stillbirths, induced abortions, minor congenital anomalies, and adverse pregnancy outcomes. [ Time Frame: January 2017 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 350
Study Start Date: November 2009
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Fibromyalgia/prospective pregnancies
Women taking Savella during pregnancy. Register prospectively, provide verbal consent.

Detailed 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 Forest.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Women who are exposed to Savella during pregnancy.

Inclusion Criteria:

  • Females exposed to Savella during pregnancy
  • Willing to provide verbal consent
  • 18 y/o, US citizen

Exclusion Criteria:

  • Male
  • Under 18 y/o
  • Females not pregnant, not exposed to savella
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01026077

Contact: Savella Pregnancy Registry associate 877-643-3010

United States, North Carolina
INC Research Recruiting
Wilmington, North Carolina, United States, 28405
Contact: Wayne Wilson, MPH    877-643-3010   
Contact: Susan Goodlow    877-643-3010   
Sponsors and Collaborators
INC Research
Actavis Inc.
Principal Investigator: Susan Sinclair, RN, PhD Sr. Epidemiologist
  More Information

Additional Information:
Responsible Party: INC Research Identifier: NCT01026077     History of Changes
Other Study ID Numbers: MLN-MD-30 
Study First Received: December 3, 2009
Last Updated: December 15, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by INC Research:
Savella pregnant
savella pregnancy
fibromyalgia pregnant
fibromyalgia pregnancy
pregnancy registry savella

Additional relevant MeSH terms:
Muscular Diseases
Myofascial Pain Syndromes
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Rheumatic Diseases
Adrenergic Agents
Adrenergic Uptake Inhibitors
Antidepressive Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors processed this record on May 26, 2016