Status:
COMPLETED
Neuroprotection With Phenytoin in Optic Neuritis
Lead Sponsor:
University College, London
Collaborating Sponsors:
National Multiple Sclerosis Society
Multiple Sclerosis Society of Great Britain and Northern Ireland
Conditions:
Optic Neuritis
Multiple Sclerosis
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
Optic neuritis is caused by inflammation of the optic nerve and causes loss of vision in the affected eye. It is often associated with multiple sclerosis. Loss of vision after an attack of optic neuri...
Detailed Description
Demyelinating optic neuritis is the most common cause of acute reversible visual loss in young adults of Northern European Origin. There is a strong association with multiple sclerosis and up to 75% o...
Eligibility Criteria
Inclusion
- Diagnosis of acute optic neuritis
- Visual acuity in affected eye ≤ 6/12
- Corrected vision in normal eye ≥ 6/6
- No history of optic neuritis or other ocular disease in either eye
- ≤ 14 days since onset of visual loss
Exclusion
- Contraindication or known allergy to Phenytoin
- Contraindication to MRI
- Use of a calcium channel or sodium channel blocker in the past 2 months
- Corticosteroid use in the past 2 months
- Tysabri infusion in the past 3 months
- MS with major temperature dependent disability
- Relapsing remitting MS of greater than 10 yrs duration or EDSS\>3
- Pregnancy
- Breast Feeding
- Significant cardiac, renal or liver abnormalities
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT01451593
Start Date
November 1 2011
End Date
March 1 2015
Last Update
September 9 2015
Active Locations (2)
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1
National Hospital for Neurology and Neurosurgery
London, United Kingdom, WC1 3BG
2
Royal Hallamshire Hospital
Sheffield, United Kingdom