ClinicalTrials.gov
ClinicalTrials.gov Menu

The Savella Pregnancy Registry (SPR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01026077
Recruitment Status : Recruiting
First Posted : December 4, 2009
Last Update Posted : April 3, 2018
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
INC Research

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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 Allergan (formerly Actavis PLC and Forest Laboratories Inc.) and managed by INC Research, LLC.

Condition or disease
Fibromyalgia

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 Allergan.

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Observational [Patient Registry]
Estimated Enrollment : 350 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: The Savella Pregnancy Registry
Study Start Date : November 2009
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Fibromyalgia/prospective pregnancies
Women taking Savella during pregnancy. Register prospectively, provide verbal consent.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Estimate the prevalence of spontaneous abortions, stillbirths, induced abortions, minor congenital anomalies, and adverse pregnancy outcomes. [ Time Frame: January 2017 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Women who are exposed to Savella during pregnancy.
Criteria

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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01026077


Contacts
Contact: Savella Pregnancy Registry associate 877-643-3010 pregnancyregistries@incresearch.com

Locations
United States, North Carolina
INC Research Recruiting
Wilmington, North Carolina, United States, 28405
Contact    877-643-3010    pregnancyregistries@incresearch.com   
Sponsors and Collaborators
INC Research
Allergan
Investigators
Principal Investigator: Susan Sinclair, RN, PhD Sr. Epidemiologist
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Study and enrollment information for healthcare providers and patients  This link exits the ClinicalTrials.gov site

Responsible Party: INC Research
ClinicalTrials.gov Identifier: NCT01026077     History of Changes
Other Study ID Numbers: MLN-MD-30
First Posted: December 4, 2009    Key Record Dates
Last Update Posted: April 3, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Milnacipran
Antidepressive Agents
Psychotropic Drugs
 Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents