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: December 12, 2011

Last verified: December 2011

History of Changes

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:

Genetics Home Reference related topics: ataxia neuropathy spectrum childhood myocerebrohepatopathy spectrum deoxyguanosine kinase deficiency Leber hereditary optic neuropathy Lenz microphthalmia syndrome mitochondrial neurogastrointestinal encephalopathy disease myoclonic epilepsy myopathy sensory ataxia oculofaciocardiodental syndrome Peters plus syndrome

U.S. FDA Resources

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

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:

Klopstock T, Yu-Wai-Man P, Dimitriadis K, Rouleau J, Heck S, Bailie M, Atawan A, Chattopadhyay S, Schubert M, Garip A, Kernt M, Petraki D, Rummey C, Leinonen M, Metz G, Griffiths PG, Meier T, Chinnery PF. A randomized placebo-controlled trial of idebenone in Leber's hereditary optic neuropathy. Brain. 2011 Jul 25; [Epub ahead of print]

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:	December 12, 2011
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 Nerve Diseases
Optic Atrophy, Hereditary, Leber
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases
Optic Atrophies, Hereditary
Optic Atrophy

Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn
Mitochondrial Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on May 16, 2013

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