THE SAVELLA® PREGNANCY REGISTRY (MLN-MD-30 / CMO-EPI-NEU-0539)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/35070
• EU PAS number:
  EUPAS22236
• Study ID:
  35070
• Official title and acronym:
  THE SAVELLA® PREGNANCY REGISTRY (MLN-MD-30 / CMO-EPI-NEU-0539)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This is a prospective, observational, exposure-registration and follow-up registry of women and their offspring exposed to Savella during pregnancy and among infants during the first year of life.
• Study status:
  Finalised

Research institutions and networks

Institutions

Syneos Health

United Kingdom

Study timelines

Date when funding contract was signed

Actual: 08/07/2009

Study start date

Actual: 04/12/2009

Date of final study report

Actual: 31/01/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Allergan plc

Study protocol

Initial protocol

Savella MLN-MD-30 Protocol EUPAS

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

NCT01026077