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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease |
---|
Fibromyalgia |
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 |

Group/Cohort |
---|
Fibromyalgia/prospective pregnancies
Women taking Savella during pregnancy. Register prospectively, provide verbal consent.
|
- 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 ]
- Estimate the prevalence of spontaneous abortions, stillbirths, induced abortions, minor congenital anomalies, and adverse pregnancy outcomes. [ Time Frame: January 2017 ]

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, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
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

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
Contact: Savella Pregnancy Registry associate | 877-643-3010 | pregnancyregistries@incresearch.com |
United States, North Carolina | |
INC Research | Recruiting |
Wilmington, North Carolina, United States, 28405 | |
Contact 877-643-3010 pregnancyregistries@incresearch.com |
Principal Investigator: | Susan Sinclair, RN, PhD | Sr. Epidemiologist |
Additional Information:
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 |