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Lipoic Acid as a Treatment for Acute Optic Neuritis

Primary Purpose

Optic Neuritis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Lipoic Acid
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Optic Neuritis focused on measuring Optic Neuritis, Lipoic Acid, Multiple Sclerosis, Antioxidant, OCT, Acute

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Oregon Health & Science University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Oral Lipoic Acid

Avicel™

Arm Description

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.

The placebo is Avicel™ (microcellulose crystal) and 4.3 mg quercetin (a bioflavanoid).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 10, 2010
Last Updated
April 25, 2019
Sponsor
Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT01294176
Brief Title
Lipoic Acid as a Treatment for Acute Optic Neuritis
Official Title
Lipoic Acid as a Treatment for Acute Optic Neuritis: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Optic Neuritis
Keywords
Optic Neuritis, Lipoic Acid, Multiple Sclerosis, Antioxidant, OCT, Acute

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral Lipoic Acid
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Avicel™
Arm Type
Placebo Comparator
Arm Description
The placebo is Avicel™ (microcellulose crystal) and 4.3 mg quercetin (a bioflavanoid).
Intervention Type
Drug
Intervention Name(s)
Lipoic Acid
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
Baseline, Week 24
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
Baseline, Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

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Lipoic Acid as a Treatment for Acute Optic Neuritis

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