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Lipoic Acid as a Treatment for Acute Optic Neuritis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2015 by Vijayshree Yadav, Oregon Health and Science University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01294176
First Posted: February 11, 2011
Last Update Posted: February 4, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Vijayshree Yadav, Oregon Health and Science University
August 10, 2010
February 11, 2011
February 4, 2015
January 2011
October 2015   (Final data collection date for 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 ]
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.
Same as current
Complete list of historical versions of study NCT01294176 on ClinicalTrials.gov Archive Site
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 ]
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.
Same as current
Not Provided
Not Provided
 
Lipoic Acid as a Treatment for Acute Optic Neuritis
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.

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.

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Optic Neuritis
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.
  • 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.
    Intervention: Drug: Lipoic Acid
  • Placebo Comparator: Avicel™
    The placebo is Avicel™ (microcellulose crystal) and 4.3 mg quercetin (a bioflavanoid).
    Intervention: Drug: Lipoic Acid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
54
October 2015
October 2015   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01294176
OHSU IRB00005634
Yes
Not Provided
Not Provided
Vijayshree Yadav, Oregon Health and Science University
Oregon Health and Science University
Not Provided
Not Provided
Oregon Health and Science University
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP