Optic NeuritisPhase 1NCT01294176
Lipoic Acid as a Treatment for Acute Optic Neuritis
A Phase 1 study testing Lipoic Acid in people with Optic Neuritis, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The purpose of this study is to determine if oral lipoic acid can safely help relieve permanent optic nerve injury in patients diagnosed with acute optic neuritis. It will also explore how the body absorbs and breaks down the study drug, and what effects it has on the immune system. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Optic Neuritis
- What is being tested?
- Lipoic Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Nov 2016
- Phase
- Phase 1
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of acute, unilateral AON with visual symptoms (vision loss) of 14 days or less
- 18 - 65 years of age, inclusive
- AON as a first event (possibly idiopathic) or in relationship to clinically isolated syndrome or to MS according to McDonald criteria
- No previous history of optic neuritis or ophthalmoscopic signs of optic atrophy in the affected eye
- Subject is available for treatment initiation within 14 days of onset of AON symptoms
Who cannot join
- Other causes of visual loss in the affected eye (e.g. amblyopia or glaucoma
- OCT is non-evaluable at screening visit due to edema.
- AON symptoms improve before administration of study medication.
- Subject has fever or active infection at time of enrollment.
- Subject is pregnant or breast-feeding.
- Subject has diabetes mellitus.
- Subject has another significant health problem (e.g. active coronary heart disease, liver disease, significant pulmonary disease).
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Lipoic Acid as a Treatment for Acute Optic Neuritis: A Pilot Study
The purpose of this study is to determine if oral lipoic acid can safely help relieve permanent optic nerve injury in patients diagnosed with acute optic neuritis. It will also explore how the body absorbs and breaks down the study drug, and what effects it has on the immune system.
Read the detailed description
Oral lipoic acid is an antioxidant that helps proteins work in the body. It is available in oral and intravenous formulations and has been used in the past to treat nerve damage like that seen in diabetes and some other metabolic disorders. It is available as a dietary supplement in the United States.
Patients with a diagnosis of acute optic neuritis who are enrolled in the study will undergo medical and nervous system examinations, and blood draws. The study doctor will take a medical history and perform physical examinations. Research assistants at the MS Center, who are trained in blood draws, will perform the blood draws. Patients will also undergo Optical coherence tomography (OCT) examination at Casey Eye Institute, and receive two MRIs at Oregon Health and Science University (OHSU). Because it is a placebo-controlled trial, subjects will have a 50:50 chance of receiving either placebo (inactive) or study drug. If enrolled in the study, patients will take two gel capsules of the study drug or placebo at the same time every day for six weeks.
- Conditions
- Optic Neuritis
- Being tested
- Lipoic Acid
- Keywords
- Optic Neuritis, Lipoic Acid, Multiple Sclerosis, Antioxidant, OCT, Acute
- Medical subject headings
- Optic Neuritis, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipoic AcidDrug
Lipoic acid will be administered orally, in two 600mg capsules, for a total 1200mg dose. The dose will be administered daily for a 6-week treatment period.
| Study group | Role | What they receive |
|---|---|---|
| Oral Lipoic Acid | Active comparator | Lipoic acid is a natural antioxidant available as an oral dietary supplement. A higher than average dose of 1200mg will be administered in this trial. Receives: Drug: Lipoic Acid |
| Avicel™ | Placebo comparator | The placebo is Avicel™ (microcellulose crystal) and 4.3 mg quercetin (a bioflavanoid). Receives: Drug: Lipoic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure will be the difference from baseline in retinal nerve fiber layer (RNFL) thickness of the affected optic nerve, as determined by OCT, at 12 and 24weeks post LA treatment.
Individual data will be assessed at the last study visit (six months post baseline). Group data cannot be assessed until all participants have exited the study. The time frame for final assessment of the primary outcome measure is dependent on how quickly the recruitment goal is met.
Measured: Baseline, Week 24
Secondary outcomes (1)
Secondary outcome measures to assess optic nerve injury will be changes from baseline in the RNFL thickness at week 24, and changes from baseline in low- and high-contrast visual acuity, contrast sensitivity, and visual field changes at weeks 12 and 24.
Individual data will be assessed at the last study visit (six months post baseline). Group data cannot be assessed until all participants have exited the study. The time frame for final assessment of the primary outcome measure is dependent on how quickly the recruitment goal is met.
Measured: Baseline, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optic NeuritisStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vijayshree Yadav, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01294176
- Sponsor's protocol ID
- OHSU IRB00005634
- Status last verified
- Apr 2019
- First submitted
- 10 Aug 2010
- Last updated
- 26 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lipoic Acid as a Treatment for Acute Optic Neuritis: A Pilot Study
- ClinicalTrials.gov ID
- NCT01294176
- Acronym / sponsor ID
- OHSU IRB00005634
- Conditions
- Optic Neuritis
- Keywords
- Optic Neuritis, Lipoic Acid, Multiple Sclerosis, Antioxidant, OCT, Acute
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 11 Feb 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 purpose of this study is to determine if oral lipoic acid can safely help relieve permanent optic nerve injury in patients diagnosed with acute optic neuritis. It will also explore how the body absorbs and breaks down the study drug, and what effects it has on the immune system.
Detailed description
Oral lipoic acid is an antioxidant that helps proteins work in the body. It is available in oral and intravenous formulations and has been used in the past to treat nerve damage like that seen in diabetes and some other metabolic disorders. It is available as a dietary supplement in the United States.
Patients with a diagnosis of acute optic neuritis who are enrolled in the study will undergo medical and nervous system examinations, and blood draws. The study doctor will take a medical history and perform physical examinations. Research assistants at the MS Center, who are trained in blood draws, will perform the blood draws. Patients will also undergo Optical coherence tomography (OCT) examination at Casey Eye Institute, and receive two MRIs at Oregon Health and Science University (OHSU). Because it is a placebo-controlled trial, subjects will have a 50:50 chance of receiving either placebo (inactive) or study drug. If enrolled in the study, patients will take two gel capsules of the study drug or placebo at the same time every day for six weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Lipoic Acid | Active comparator | Drug: Lipoic AcidLipoic acid is a natural antioxidant available as an oral dietary supplement. A higher than average dose of 1200mg will be administered in this trial. |
| Avicel™ | Placebo comparator | Drug: Lipoic AcidThe placebo is Avicel™ (microcellulose crystal) and 4.3 mg quercetin (a bioflavanoid). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of acute, unilateral AON with visual symptoms (vision loss) of 14 days or less
- 18 - 65 years of age, inclusive
- AON as a first event (possibly idiopathic) or in relationship to clinically isolated syndrome or to MS according to McDonald criteria
- No previous history of optic neuritis or ophthalmoscopic signs of optic atrophy in the affected eye
- Subject is available for treatment initiation within 14 days of onset of AON symptoms
Key exclusion criteria (7 listed)
- Other causes of visual loss in the affected eye (e.g. amblyopia or glaucoma
- OCT is non-evaluable at screening visit due to edema.
- AON symptoms improve before administration of study medication.
- Subject has fever or active infection at time of enrollment.
- Subject is pregnant or breast-feeding.
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 |
|---|---|---|
| Lipoic AcidLipoic acid will be administered orally, in two 600mg capsules, for a total 1200mg dose. The dose will be administered daily for a 6-week treatment period. | Drug | Avicel™, Oral Lipoic Acid |
Primary outcome
The primary outcome measure will be the difference from baseline in retinal nerve fiber layer (RNFL) thickness of the affected optic nerve, as determined by OCT, at 12 and 24weeks post LA treatment.
Time frame: Baseline, Week 24
Individual data will be assessed at the last study visit (six months post baseline). Group data cannot be assessed until all participants have exited the study. The time frame for final assessment of the primary outcome measure is dependent on how quickly the recruitment goal is met.
1 secondary outcome
Secondary outcome measures to assess optic nerve injury will be changes from baseline in the RNFL thickness at week 24, and changes from baseline in low- and high-contrast visual acuity, contrast sensitivity, and visual field changes at weeks 12 and 24.
Time frame: Baseline, Week 24
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 26 Apr 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lipoic Acid in people with Optic Neuritis, run by Oregon Health and Science University at 1 site in United States.
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 5 inclusion and 7 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 26 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 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?
The primary outcome measure will be the difference from baseline in retinal nerve fiber layer (RNFL) thickness of the affected optic nerve, as determined by OCT, at 12 and 24weeks post LA treatment. (time frame: Baseline, Week 24). It is what the study was designed to measure, not a finding.
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 26 Apr 2019.