Optic Neuritis Recovery After Oral or IV Corticosteroids

• Status: Completed
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: London Health Sciences Centre
• Collaborator: The Physicians' Services Incorporated Foundation
• Treatments: Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Prednisone

Criteria

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prior to any study related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to his/her future medical care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