Post Authorisation Safety Study With Raxone in LHON Patients (PAROS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02771379|
Recruitment Status : Completed
First Posted : May 13, 2016
Last Update Posted : July 16, 2021
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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.
|Condition or disease||Intervention/treatment|
|Leber's Hereditary Optic Neuropathy (LHON)||Drug: Idebenone|
|Study Type :||Observational|
|Actual Enrollment :||229 participants|
|Official Title:||A Non-interventional Study of Clinical Experience in Patients Prescribed Raxone® for the Treatment of Leber's Hereditary Optic Neuropathy (LHON)|
|Study Start Date :||September 2016|
|Actual Primary Completion Date :||April 16, 2021|
|Actual Study Completion Date :||April 16, 2021|
|Patients who are treated with Raxone®||
Raxone 900mg/day as per Raxone SmPC and medical judgement of treating physician.
Other Name: Raxone®
- 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)
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- 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.
- No explicit exclusion criteria exist to avoid selection bias and to allow for documentation of routine clinical practice.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02771379
|Responsible Party:||Santhera Pharmaceuticals|
|Other Study ID Numbers:||
|First Posted:||May 13, 2016 Key Record Dates|
|Last Update Posted:||July 16, 2021|
|Last Verified:||July 2021|
Optic Nerve Diseases
Optic Atrophy, Hereditary, Leber
Cranial Nerve Diseases
Nervous System Diseases
Optic Atrophies, Hereditary
Heredodegenerative Disorders, Nervous System
Eye Diseases, Hereditary
Genetic Diseases, Inborn
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs