Non-Interventional Post-Authorisation Safety Study of NUCEIVA for the Treatment of Moderate-to-Severe Glabellar Lines (EV-010)

Study identification

• EU PAS number:
  EUPAS48390
• Study ID:
  49251
• Official title and acronym:
  Non-Interventional Post-Authorisation Safety Study of NUCEIVA for the Treatment of Moderate-to-Severe Glabellar Lines (EV-010)
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Spain

  Sweden

  United Kingdom
• Study description:
  This is a prospective, multicentre, NI observational PASS, the 3 cohorts of interest include the total Safety Population, and the 2 sub-populations of botulinum toxin naïve and non-naïve patients. The purpose of this NI PASS is to add to the body of safety data collected in the clinical trial programme by further quantifying safety concerns and providing additional characterisation of the long-term safety of NUCEIVA that is reflective of real-world clinical practice. Safety data will be collected from approximately 750 patients at 20 sites throughout the UK and EU over an 18 month evaluation period.
• Study status:
  Planned

Research institutions and networks

Institutions

Evolus Pharma

Study timelines

Date when funding contract was signed

Planned:18/11/2019

Study start date

Planned:10/01/2023

Date of final study report

Planned:30/03/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Evolus Inc.

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)