Leber's Hereditary Optic NeuropathyPhase 3NCT01495715
Study With Idebenone in Patients With Chronic Vision Loss Due to Leber's Hereditary Optic Neuropathy (LHON)
A Phase 3 study testing Idebenone in people with Leber's Hereditary Optic Neuropathy, run by Santhera Pharmaceuticals.
Trial summary
The objective of the study is to determine whether administration of idebenone can shorten the time to improvement of visual acuity in patients with chronic vision loss due to LHON. Read more about this study
- Who is it for?
- Ages 10 to 65 years
- Conditions the study is for
- Leber's Hereditary Optic Neuropathy
- What is being tested?
- Idebenone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 3
- 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 10 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age > or equal 10 years and < 65 years
- Impaired visual acuity in affected eyes due to LHON: Visual acuity in best eye >0.4 logMAR
- No explanation for visual loss besides LHON
Who cannot join
- Any previous use of idebenone
- Participation in another clinical trial of any investigational drug within 3 months prior to Baseline
- Previous participation in Study SNT-II-003 (RHODOS) for idebenone.
About this study
The objective of the study is to determine whether administration of idebenone can shorten the time to improvement of visual acuity in patients with chronic vision loss due to LHON.
- Conditions
- Leber's Hereditary Optic Neuropathy
- Being tested
- Idebenone, Placebo
- Medical subject headings
- Optic Atrophy, Hereditary, Leber
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IdebenoneDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Idebenone | Experimental | Not described Receives: Drug: Idebenone |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase 3
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Santhera Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01495715
- Sponsor's protocol ID
- SNT-III-011
- Status last verified
- Aug 2014
- First submitted
- 16 Dec 2011
- Last updated
- 22 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study With Idebenone in Patients With Chronic Vision Loss Due to Leber's Hereditary Optic Neuropathy (LHON)
- ClinicalTrials.gov ID
- NCT01495715
- Acronym / sponsor ID
- SNT-III-011
- Conditions
- Leber's Hereditary Optic Neuropathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Santhera PharmaceuticalsIndustry (pharma, biotech, devices)
- First posted
- 20 Dec 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.
The objective of the study is to determine whether administration of idebenone can shorten the time to improvement of visual acuity in patients with chronic vision loss due to LHON.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Idebenone | Experimental | Drug: Idebenone |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 10 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age > or equal 10 years and < 65 years
- Impaired visual acuity in affected eyes due to LHON: Visual acuity in best eye >0.4 logMAR
- No explanation for visual loss besides LHON
Key exclusion criteria (3 listed)
- Any previous use of idebenone
- Participation in another clinical trial of any investigational drug within 3 months prior to Baseline
- Previous participation in Study SNT-II-003 (RHODOS) for idebenone.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Idebenone | Drug | Idebenone |
| Placebo | Drug | Placebo |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Idebenone in people with Leber's Hereditary Optic Neuropathy, run by Santhera Pharmaceuticals.
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 3 inclusion and 3 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: withdrawn, as of the sponsor's last update on 22 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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.
Where can I read the original study information?
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 22 Aug 2014.