- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01294176
Lipoic Acid as a Treatment for Acute Optic Neuritis
Lipoic Acid as a Treatment for Acute Optic Neuritis: A Pilot Study
Study Overview
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 Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Oregon
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Portland, Oregon, United States, 97239
- Oregon Health & Science University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Oral Lipoic Acid
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.
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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.
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Placebo Comparator: Avicel™
The placebo is Avicel™ (microcellulose crystal) and 4.3 mg quercetin (a bioflavanoid).
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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Baseline, Week 24
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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Baseline, Week 24
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Eye Diseases
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Optic Nerve Diseases
- Cranial Nerve Diseases
- Neuritis
- Optic Neuritis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Protective Agents
- Micronutrients
- Vitamins
- Antioxidants
- Vitamin B Complex
- Thioctic Acid
Other Study ID Numbers
- OHSU IRB00005634
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Optic Neuritis
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Medical University of ViennaUnknownOptic; Neuritis, With DemyelinationAustria
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BiogenCompletedAcute Optic NeuritisSweden, Australia, Italy, Spain, United Kingdom, Germany, Belgium, Denmark, Hungary, Czech Republic, Canada
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Novartis PharmaceuticalsTerminatedAcute Demylelinating Optic NeuritisUnited States, Spain
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BiogenCompletedAcute Optic NeuritisSweden, Spain, United Kingdom, Germany, Canada, Denmark, Hungary, Belgium, Czechia, Australia, Italy
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Accure TherapeuticsSimbec ResearchCompletedOptic Neuritis | Optic; Neuritis, With DemyelinationUnited Kingdom
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OculisNeurotrialsRecruitingOptic Neuritis | Optic; Neuritis, With DemyelinationFrance
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Teva Branded Pharmaceutical Products R&D, Inc.Completed
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