The Savella Pregnancy Registry (SPR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by INC Research
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
INC Research
ClinicalTrials.gov Identifier:
NCT01026077
First received: December 3, 2009
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

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 Forest Laboratories Inc. (Forest) and managed by INC Research, LLC.


Condition
Fibromyalgia

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)
Groups/Cohorts
Fibromyalgia/prospective pregnancies
Women taking Savella during pregnancy. Register prospectively, provide verbal consent.

  Eligibility

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.

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
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 ClinicalTrials.gov identifier: 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: Wayne Wilson, MPH    877-643-3010    pregnancyregistries@incresearch.com   
Contact: Susan Goodlow    877.643.3010    pregnancyregistries@incresearch.com   
Sponsors and Collaborators
INC Research
Forest Laboratories
Investigators
Principal Investigator: Susan Sinclair, RN, PhD Sr. Epidemiologist
  More Information

Additional Information:
No publications provided

Responsible Party: INC Research
ClinicalTrials.gov Identifier: NCT01026077     History of Changes
Other Study ID Numbers: MLN-MD-30
Study First Received: December 3, 2009
Last Updated: March 10, 2014
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
Fibromyalgia
Myofascial Pain Syndromes
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Milnacipran
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents

ClinicalTrials.gov processed this record on August 20, 2014