Lipoic Acid as a Treatment for Acute Optic Neuritis

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Oregon Health and Science University
Sponsor:
Information provided by (Responsible Party):
Vijayshree Yadav, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01294176
First received: August 10, 2010
Last updated: November 2, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Optic Neuritis
Drug: Lipoic Acid
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Lipoic Acid as a Treatment for Acute Optic Neuritis: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

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. [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
    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. [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 54
Study Start Date: January 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Lipoic Acid
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.
Placebo Comparator: Avicel™
The placebo is Avicel™ (microcellulose crystal) and 4.3 mg quercetin (a bioflavanoid).
Drug: Lipoic Acid
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • No evidence of a systemic disease associated with the optic neuritis, such as other autoimmune diseases (e.g., lupus)
  • 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01294176

Contacts
Contact: Melissa Tee, MA 503-494-3549 teem@ohsu.edu

Locations
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Principal Investigator: Vijayshree Yadav, MD         
Sponsors and Collaborators
Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Vijayshree Yadav, Principal Investigator, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01294176     History of Changes
Other Study ID Numbers: OHSU IRB00005634
Study First Received: August 10, 2010
Last Updated: November 2, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
Optic Neuritis
Lipoic Acid
Multiple Sclerosis
Antioxidant
OCT
Acute

Additional relevant MeSH terms:
Neuritis
Optic Neuritis
Cranial Nerve Diseases
Eye Diseases
Nervous System Diseases
Neuromuscular Diseases
Optic Nerve Diseases
Peripheral Nervous System Diseases
Thioctic Acid
Antioxidants
Growth Substances
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Vitamin B Complex
Vitamins

ClinicalTrials.gov processed this record on October 23, 2014