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Post Authorisation Safety Study With Raxone in LHON Patients (PAROS)

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Santhera

Status

Completed

Conditions

Leber's Hereditary Optic Neuropathy (LHON)

Treatments

Drug: Idebenone

Study type

Observational

Funder types

Industry

Identifiers

NCT02771379
SNT-IV-003

Details and patient eligibility

About

This study is a multicentre, prospective, non-interventional post-authorisation safety study (PASS) of the clinical outcomes for patients with LHON treated with Raxone®.

No medication will be provided as part of this study. Raxone® will be obtained through commercial channels.

Enrollment

229 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patient prescribed Raxone® for the treatment of LHON;
  • Patient has completed an Informed Consent Form (ICF) indicating that he/she (or a legally acceptable representative) has been informed of all pertinent aspects of the study and has agreed to participate in the study;
  • Patient is not participating in any interventional study.

Exclusion criteria

  • No explicit exclusion criteria exist to avoid selection bias and to allow for documentation of routine clinical practice.

Trial design

229 participants in 1 patient group

Patients who are treated with Raxone®
Treatment:
Drug: Idebenone

Trial contacts and locations

26

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Data sourced from clinicaltrials.gov

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