RHODOS Follow-up Single-visit Study (RHODOS-OFU)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Santhera Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01421381
First received: August 19, 2011
Last updated: May 24, 2013
Last verified: May 2013
  Purpose

This study aims to evaluate the current visual acuity of SNT-II-003 participants and compare this with the last visit from the SNT-II-003 study.


Condition
Leber's Hereditary Optic Neuropathy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Single Visit, Observational, Follow-up Study of Patients With Leber's Hereditary Optic Neuropathy Following Participation in SNT-II-003 Trial

Resource links provided by NLM:


Further study details as provided by Santhera Pharmaceuticals:

Primary Outcome Measures:
  • logMAR visual acuity [ Time Frame: measure taken at the single study visit (Week 24) ] [ Designated as safety issue: No ]
    Change in best logMAR visual acuity (Best Acuity) compared to Visit 2/Baseline and Visit 5/Week 24 or last treatment visit of SNT-II-003


Enrollment: 60
Study Start Date: September 2011
Study Completion Date: December 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   15 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients who participated in study SNT-II-003

Criteria

Inclusion Criteria:

  • Previous participation in study SNT-II-003
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01421381

Locations
Canada, Quebec
Hôpital Notre-Dame (CHUM)
Montreal,, Quebec, Canada, H2L 4M1
Germany
Friedrich Baur Institut Neurologische Klinik und Poliklinik
München, Germany, D-80336
United Kingdom
Biomedical Research Centre, The Medical School
Newcastle upon Tyne, United Kingdom, NE2 4HH
Sponsors and Collaborators
Santhera Pharmaceuticals
Investigators
Principal Investigator: Patrick Chinnery, MD Clinical Research Facility
  More Information

Publications:
Responsible Party: Santhera Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01421381     History of Changes
Other Study ID Numbers: SNT-II-003-OFU
Study First Received: August 19, 2011
Last Updated: May 24, 2013
Health Authority: Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Canada: Ethics Review Committee
Canada: Health Canada
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: National Health Service

Keywords provided by Santhera Pharmaceuticals:
leber's hereditary optic neuropathy
idebenone

Additional relevant MeSH terms:
Optic Atrophy, Hereditary, Leber
Optic Atrophies, Hereditary
Eye Diseases, Hereditary
Optic Nerve Diseases
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases
Optic Atrophy
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Mitochondrial Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on September 16, 2014