The Savella Pregnancy Registry (SPR)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified September 2016 by INC Research
Sponsor:
INC Research
Collaborator:
Allergan
Information provided by (Responsible Party):
INC Research
ClinicalTrials.gov Identifier:
NCT01026077
First received: December 3, 2009
Last updated: September 20, 2016
Last verified: September 2016
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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 Allergan (formerly Actavis PLC and Forest Laboratories Inc.) 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: | September 2019 |
| Estimated Primary Completion Date: | September 2019 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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 Allergan.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| 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
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 877-643-3010 pregnancyregistries@incresearch.com | |
Sponsors and Collaborators
INC Research
Allergan
Investigators
| Principal Investigator: | Susan Sinclair, RN, PhD | Sr. Epidemiologist |
More Information
Additional Information:
| 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: | September 20, 2016 |
| 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 |
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 |
ClinicalTrials.gov processed this record on September 30, 2016