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OpenTrials
Completed

NCT Number: NCT02771379

Post Authorisation Safety Study With Raxone in LHON Patients

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.

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Key information

Conditions

Leber's Hereditary Optic Neuropathy (LHON) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cranial Nerve Diseases Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Metabolic Diseases Mitochondrial Diseases Nervous System Diseases Neurodegenerative Diseases Nutritional and Metabolic Diseases Optic Atrophies, Hereditary Optic Atrophy Optic Atrophy, Hereditary, Leber Optic Nerve Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitaetsklinikum Graz, Graz, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Idebenone

Drug

Raxone 900mg/day as per Raxone SmPC and medical judgement of treating physician.

Other names: Raxone®

Primary outcomes

  1. Long-term safety profile of Raxone® in the treatment of patients with LHON when used under conditions of routine clinical care.

    Time frame: up to 5 years

    Safety will be assessed by the collection and analysis of adverse events of special interest (AESIs), frequency and nature of AEs and serious adverse events (SAEs), adverse drug reactions (ADRs) and serious adverse drug reactions (SADRs)

Secondary outcomes

  1. Long-term effectiveness of Raxone® in the treatment of patients with LHON when used under conditions of routine clinical care

    Time frame: up to 5 years

    According to the Summary of Product Characteristics (SmPC) a patient's vision should be continually monitored therefore effectiveness will be assessed by measuring on-therapy changes in patients' visual acuity (VA), visual fields (VF), colour contrast sensitivity and Retinal Nerve Fibre Layer thickness (RNFL) where available.

Sponsors and collaborators

Lead sponsor

Santhera Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: PAROS

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
May 13, 2016
Registry last updated
Jul 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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