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The Savella Pregnancy Registry (SPR)

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ClinicalTrials.gov Identifier: NCT01026077
Recruitment Status : Recruiting
First Posted : December 4, 2009
Last Update Posted : April 5, 2019
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Syneos Health

Tracking Information
First Submitted Date December 3, 2009
First Posted Date December 4, 2009
Last Update Posted Date April 5, 2019
Study Start Date November 2009
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 3, 2009)
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 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01026077 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 3, 2009)
Estimate the prevalence of spontaneous abortions, stillbirths, induced abortions, minor congenital anomalies, and adverse pregnancy outcomes. [ Time Frame: January 2017 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Savella Pregnancy Registry
Official Title The Savella Pregnancy Registry
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 Syneos Health.
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 Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 1 Year
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Women who are exposed to Savella during pregnancy.
Condition Fibromyalgia
Intervention Not Provided
Study Groups/Cohorts Fibromyalgia/prospective pregnancies
Women taking Savella during pregnancy. Register prospectively, provide verbal consent.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 3, 2009)
350
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Savella Pregnancy Registry associate 877-643-3010 pregnancyregistries@syneoshealth.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01026077
Other Study ID Numbers MLN-MD-30
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Syneos Health
Study Sponsor Syneos Health
Collaborators Allergan
Investigators
Principal Investigator: Sara Ephross, PhD Sr. Advisor, Epidemiology & Health Outcomes
PRS Account Syneos Health
Verification Date April 2019