Lipoic Acid as a Treatment for Acute Optic Neuritis

NCT01294176 | Completed Phase 1 DMC

• 1 other identifier: OHSU IRB00005634
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Optic Neuritis

Keywords

Optic Neuritis; Lipoic Acid; Multiple Sclerosis; Antioxidant; OCT; Acute

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  Baseline, Week 24

Study Arms (2)

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.

Drug: Lipoic Acid

Avicel™

PLACEBO COMPARATOR

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

Drug: Lipoic Acid

Interventions

Lipoic Acid DRUG

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.

Avicel™; Oral Lipoic Acid

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of acute, unilateral AON with visual symptoms (vision loss) of 14 days or less
• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Optic Neuritis; Multiple Sclerosis

Interventions

Thioctic Acid

Condition Hierarchy (Ancestors)

Optic Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Carboxylic Acids; Organic Chemicals; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 10, 2010
• First Posted: February 11, 2011
• Study Start: January 1, 2011
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: April 26, 2019

Record last verified: 2019-04

Locations

US (1)