A Non-interventional Study of Clinical Experience in Patients Prescribed Raxone® for the Treatment of Leber’s Hereditary Optic Neuropathy (LHON) (PAROS)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/48523
• EU PAS number:
  EUPAS13438
• Study ID:
  48523
• Official title and acronym:
  A Non-interventional Study of Clinical Experience in Patients Prescribed Raxone® for the Treatment of Leber’s Hereditary Optic Neuropathy (LHON) (PAROS)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  France

  Germany

  Greece

  Italy

  Netherlands

  Norway
• Study description:
  This study is a multicentre, prospective, non-interventional post-authorisation safety study (PASS) to collect additional information on the use of Raxone® when used under conditions of routine clinical practice.
• Study status:
  Finalised

Study timelines

Date when funding contract was signed

Planned: 01/10/2015

Actual: 23/09/2016

Study start date

Planned: 03/10/2016

Actual: 23/09/2016

Date of final study report

Planned: 13/12/2021

Actual: 18/05/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Santhera Pharmaceuticals (Switzerland) Ltd

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 2 (specific obligation of marketing authorisation)