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Optic Neuritis Recovery After Oral or IV Corticosteroids

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. Identifier: NCT01524250
Recruitment Status : Completed
First Posted : February 1, 2012
Last Update Posted : September 2, 2015
The Physicians' Services Incorporated Foundation
Information provided by (Responsible Party):
Sarah Morrow, London Health Sciences Centre

Brief Summary:
Patients aged 18-65 with acute demyelinating optic neuritis where treatment with high dose corticosteroids are already been chosen by the patient and the diagnosing physician will be contacted for screening and enrollment. Patients will then be randomized to receive equivalent doses of either intravenous (IV) or oral corticosteroid treatment. Optic nerve function assessments will be compared at baseline, prior to treatment, one and six months post corticosteroid treatment. This will allow for a comparison on whether the route of medication plays a role in the effectiveness of treatment with high dose corticosteroids.

Condition or disease Intervention/treatment Phase
Optic Neuritis Drug: corticosteroids Phase 2 Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Recovery of Demyelinating Optic Neuritis After Treatment With Equivalent High Doses of Oral vs. Intravenous Corticosteroids: a Randomized Single Blinded Clinical Trial
Study Start Date : March 2012
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

Arm Intervention/treatment
Experimental: oral prednisone
1250mg oral prednisone daily for 3 days
Drug: corticosteroids
1250mg of oral prednisone daily for 3 days

Active Comparator: IV methylprednisolone
1000mg IV methylprednisolone daily for 3 days
Drug: corticosteroids
1000mg IV methylprednisolone daily for 3 days

Primary Outcome Measures :
  1. P100 latency of the Visual Evoked Potential in the affected eye [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. High contrast visual acuity [ Time Frame: one and six months ]
  2. contrast sensitivity [ Time Frame: one and six months ]
  3. P100 latency of the Visual Evoked Potential in the affected eye [ Time Frame: one month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Males/Females who are ≥ 18 years old and < 65 years old and are capable of understanding and complying with the protocol
  2. Have a diagnosis of unilateral acute demyelinating optic neuritis and will be treated with high dose corticosteroids
  3. Are within 14 days of symptom onset
  4. Have a visual acuity in the affected of eye of ≥ 20/40
  5. Have not received corticosteroids in the last thirty (30) days
  6. Medications that could potentially affect the VEP P100 amplitude or may cause drowsiness/difficulty with visual fixation are allowed if there has been no change in dose within 30 days of study enrollment or anytime during the study. These medications include:

    1. Carbamazepine or other anticonvulsants (45)
    2. Benzodiazepines
    3. Opioid and opiates
    4. Barbiturates
    5. Sleep aids such as zopiclone or trazadone
    6. Tricyclic antidepressants
  7. Have given written informed consent prior to any study related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to his/her future medical care

Exclusion Criteria:

  1. Have another medical condition that could affect the visual outcomes, such as, but not limited to, diabetes retinopathy, glaucoma, cataracts and optic neuropathy not due to a demyelinating lesion
  2. Have had optic neuritis in the same eye previously

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01524250

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Canada, Ontario
London Health Sciences Center
London, Ontario, Canada, N6A 5A5
London Health Sciences Center
London, Ontario, Canada, N6G1W8
Sponsors and Collaborators
London Health Sciences Centre
The Physicians' Services Incorporated Foundation

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Sarah Morrow, Assistant Professor of Neurology, London Health Sciences Centre Identifier: NCT01524250     History of Changes
Other Study ID Numbers: REB 18804
First Posted: February 1, 2012    Key Record Dates
Last Update Posted: September 2, 2015
Last Verified: September 2015
Keywords provided by Sarah Morrow, London Health Sciences Centre:
Multiple Sclerosis
Additional relevant MeSH terms:
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Optic Neuritis
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Optic Nerve Diseases
Cranial Nerve Diseases
Eye Diseases
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents