Leber's Hereditary Optic NeuropathyRHODOS-OFUNCT01421381
RHODOS Follow-up Single-visit Study
An observational study of Leber's Hereditary Optic Neuropathy, run by Santhera Pharmaceuticals at 3 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 15 to 69 years
- Conditions the study is for
- Leber's Hereditary Optic Neuropathy
- How many people
- 60 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Sep 2011to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 69 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who participated in study SNT-II-003
Who may be able to join
- Previous participation in study SNT-II-003
Who cannot join
None listed.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Germany1 site
Friedrich Baur Institut Neurologische Klinik und Poliklinik
München, D-80336
United Kingdom1 site
Biomedical Research Centre, The Medical School
Newcastle upon Tyne, NE2 4HH
About this study
Official title: A Single Visit, Observational, Follow-up Study of Patients With Leber's Hereditary Optic Neuropathy Following Participation in SNT-II-003 Trial
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.
- Conditions
- Leber's Hereditary Optic Neuropathy
- Keywords
- leber's hereditary optic neuropathy, idebenone
- Medical subject headings
- Optic Atrophy, Hereditary, Leber
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: measure taken at the single study visit (Week 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionNov 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Leber's Hereditary Optic NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Santhera Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrick Chinnery, MD, Principal investigator, Clinical Research Facility
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01421381
- Sponsor's protocol ID
- SNT-II-003-OFU
- Acronym
- RHODOS-OFU
- Status last verified
- May 2013
- First submitted
- 19 Aug 2011
- Last updated
- 27 May 2013
- Results posted
- No
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 Sep;134(Pt 9):2677-86. doi: 10.1093/brain/awr170. Epub 2011 Jul 25.
PubMed 21788663Klopstock T, Metz G, Yu-Wai-Man P, Buchner B, Gallenmuller 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. Brain. 2013 Feb;136(Pt 2):e230. doi: 10.1093/brain/aws279. Epub 2013 Feb 6. No abstract available.
PubMed 23388409
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Visit, Observational, Follow-up Study of Patients With Leber's Hereditary Optic Neuropathy Following Participation in SNT-II-003 Trial
- ClinicalTrials.gov ID
- NCT01421381
- Acronym / sponsor ID
- RHODOS-OFU / SNT-II-003-OFU
- Conditions
- Leber's Hereditary Optic Neuropathy
- Keywords
- leber's hereditary optic neuropathy, idebenone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Santhera PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 22 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who participated in study SNT-II-003
Key inclusion criteria (1 listed)
- Previous participation in study SNT-II-003
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
logMAR visual acuity
Time frame: measure taken at the single study visit (Week 24)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2013.
- Background: PubMed 21788663Klopstock 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.
- Results publication: PubMed 23388409Klopstock T, Metz G, Yu-Wai-Man P, Buchner B, Gallenmuller 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. Brain. 2013 Feb;136(Pt 2):e230. doi: 10.1093/brain/aws279. Epub 2013 Feb 6. No abstract available.
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Leber Hereditary Optic Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Chinnery, MD principal investigator
Clinical Research Facility
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leber's Hereditary Optic Neuropathy, run by Santhera Pharmaceuticals at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada, Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
logMAR visual acuity (time frame: measure taken at the single study visit (Week 24)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01421381, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2013.