Status:
COMPLETED
Optic Neuritis Recovery After Oral or IV Corticosteroids
Lead Sponsor:
London Health Sciences Centre
Collaborating Sponsors:
The Physicians' Services Incorporated Foundation
Conditions:
Optic Neuritis
Eligibility:
All Genders
18-64 years
Phase:
PHASE2
PHASE3
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 scr...
Detailed Description
This will be a single-blind, randomized comparison study between 1000mg IV methylprednisolone daily for three days and 1250mg oral prednisone daily for three days of the recovery of optic nerve functi...
Eligibility Criteria
Inclusion
- Males/Females who are ≥ 18 years old and \< 65 years old and are capable of understanding and complying with the protocol
- Have a diagnosis of unilateral acute demyelinating optic neuritis and will be treated with high dose corticosteroids
- Are within 14 days of symptom onset
- Have a visual acuity in the affected of eye of ≥ 20/40
- Have not received corticosteroids in the last thirty (30) days
- 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:
- Carbamazepine or other anticonvulsants (45)
- Benzodiazepines
- Opioid and opiates
- Barbiturates
- Sleep aids such as zopiclone or trazadone
- Tricyclic antidepressants
- 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prior to any study related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to his/her future medical care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
- 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
- Have had optic neuritis in the same eye previously
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT01524250
Start Date
March 1 2012
End Date
May 1 2015
Last Update
September 2 2015
Active Locations (2)
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1
London Health Sciences Center
London, Ontario, Canada, N6A 5A5
2
London Health Sciences Center
London, Ontario, Canada, N6G1W8