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NCT01421381 Clinical Trial

RHODOS Follow-up Single-visit Study

Leber's Hereditary Optic Neuropathy Clinical Trial

— RHODOS-OFU  

Official title:
A Single Visit, Observational, Follow-up Study of Patients With Leber's Hereditary Optic Neuropathy Following Participation in SNT-II-003 Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01421381
Other study ID # SNT-II-003-OFU
Secondary ID
Status Completed
Phase N/A
First received August 19, 2011
Last updated May 24, 2013
Start date September 2011
Est. completion date December 2011

Study information
Verified date May 2013
Source Santhera Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics CommissionGermany: Federal Institute for Drugs and Medical DevicesCanada: Ethics Review CommitteeCanada: Health CanadaUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: National Health Service
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date December 2011
Est. primary completion date November 2011
Accepts healthy volunteers No
Gender Both
Age group 15 Years to 69 Years
Eligibility Inclusion Criteria:

- Previous participation in study SNT-II-003

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Canada Hôpital Notre-Dame (CHUM) Montreal, Quebec
Germany Friedrich Baur Institut Neurologische Klinik und Poliklinik München
United Kingdom Biomedical Research Centre, The Medical School Newcastle upon Tyne

Sponsors (1)
Lead Sponsor Collaborator
Santhera Pharmaceuticals

Countries where clinical trial is conducted

Canada,  Germany,  United Kingdom, 

References & Publications (2)

Klopstock T, Metz G, Yu-Wai-Man P, Büchner B, Gallenmüller C, Bailie M, Nwali N, Griffiths PG, von Livonius B, Reznicek L, Rouleau J, Coppard N, Meier T, Chinnery PF. Persistence of the treatment effect of idebenone in Leber's hereditary optic neuropathy. — View Citation

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 Sep;134(Pt 9):2677-86. doi: 10.1093/brain/awr170. Epub 2011 Jul 25. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary logMAR visual acuity 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 measure taken at the single study visit (Week 24) No
See also
  Status Clinical Trial Phase
Completed NCT00747487 - Study to Assess Efficacy,Safety and Tolerability of Idebenone in the Treatment of Leber's Hereditary Optic Neuropathy Phase 2
Completed NCT04909398 - Pupil Dynamics and Color Vision for the Detection of Eye Diseases N/A
Completed NCT02693119 - A Study Investigating the Safety, Tolerability, and Efficacy of Elamipretide Topical Ophthalmic Solution for Treatment of Leber's Hereditary Optic Neuropathy Phase 2
Active, not recruiting NCT02161380 - Safety Study of an Adeno-associated Virus Vector for Gene Therapy of Leber's Hereditary Optic Neuropathy Phase 1
Withdrawn NCT01495715 - Study With Idebenone in Patients With Chronic Vision Loss Due to Leber's Hereditary Optic Neuropathy (LHON) Phase 3
No longer available NCT04381091 - Expanded Access Program for Idebenone in Patients With Leber's Hereditary Optic Neuropathy Who Completed the LEROS Study
No longer available NCT02300753 - Emergency Administration of EPI-743 to a Single Patient With Leber's Hereditary Optic Neuropathy [LHON] N/A