Multiple Sclerosis Clinical Trial
Official title:
A Phase II Double Blind, Randomized, Placebo Controlled Trial of Neuroprotection With Phenytoin in Acute Optic Neuritis
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 neuritis is caused by damage to the nerve fibres in the optic nerve. There are a
number of factors that contribute to nerve fibre damage including increased levels of sodium
within them, so blocking sodium entry could help to protect them against damage.
The purpose of this study is determine whether phenytoin (which blocks sodium entry into
cells) can protect against loss of nerve fibres and prevent loss of vision after optic
neuritis.
Status | Completed |
Enrollment | 92 |
Est. completion date | March 2015 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | National Hospital for Neurology and Neurosurgery | London | |
United Kingdom | Royal Hallamshire Hospital | Sheffield |
Lead Sponsor | Collaborator |
---|---|
University College, London | Multiple Sclerosis Society of Great Britain and Northern Ireland, National Multiple Sclerosis Society |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean Retinal nerve fibre layer thickness | The primary comparison will estimate active versus placebo mean retinal nerve fibre layer thickness of the retinal nerve fibre layer after 6 months, adjusted for the corresponding baseline measurement in the unaffected eye. | Measured at entry and after 6 months | No |
Secondary | Visual function | logMAR visual acuity, low contrast sensitvity using 1.25% and 2.5% sloan charts and colour vision using Farnsworth-Munsell 100 Hue test. | Measured at entry and 6 months | No |
Secondary | Visual evoked potentials | Measurement of latency and amplitude will be performed. Axonal protection with phenytoin may enable axons to survive long enough to undergo remyelination. VEPS will give independent estimates of remyelination in the optic nerve. | Measured at entry (or within 4 weeks) and after 6 months | No |
Secondary | Optic nerve and brain MRI | Brain MRI to detect demyelinating lesions that can be used in considering the prognosis for or diagnosis of multiple sclerosis using McDonald criteria. Optic nerve MRI - The following sequences will be performed: Fat sat T2 coronal-oblique to visualize the symptomatic lesion and obtain optic nerve area measurements. 3D gradient echo magnetization transfer sequence MTR to obtain measures of optic nerve myelination. Diffusion tensor imaging to obtain axial and radial diffusivity metrics of the optic nerve to determine axonal integrity. |
Brain MRI will be performed at entry(or within 4 weeks) Optic nerve MRI will be performed at entry (or within 4 weeks) and after 6 months | No |
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