A Retrospective and prospective, obsErvational (non-interventional), post-authorization Safety cohort sTudy to evaluate the incidence of the breAkages and insertion/Removal complications of buprenorphine implants in rouTine clinical care (RE-START)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000092
• EU PAS number:
  EUPAS1000000092
• Study ID:
  1000000092
• Official title and acronym:
  A Retrospective and prospective, obsErvational (non-interventional), post-authorization Safety cohort sTudy to evaluate the incidence of the breAkages and insertion/Removal complications of buprenorphine implants in rouTine clinical care (RE-START)
• DARWIN EU® study:
  No
• Study countries:
  Italy
• Study description:
  RE-START study, under real world conditions, aims to describe the rate of breakage of Sixmo® implants occurring during the observation period. The study population consists of adult patients with a diagnosis of opioid dependence and treated with Sixmo® as part of their routine clinical care, according to the approved Summary of Product Characteristics (SmPC).
• Study status:
  Ongoing

Research institutions and networks

Institutions

L. Molteni & C. dei Fratelli Alitti Società di Esercizio S.p.A.

Study timelines

Date when funding contract was signed

Actual: 03/05/2024

Study start date

Actual: 24/10/2022

Date of final study report

Planned: 31/12/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

The Sponsor of RE-START study is L. Molteni & C. dei Fratelli Alitti Società di Esercizio S.p.A.
(Address: Strada Statale 67 - Loc. Granatieri 50018 Scandicci (Fi), Italy)

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)
• Regulatory procedure number:
  EMEA/H/C/PSA/S/0097