europrotection with phenytoin in optic neuritis

• Conditions: Acute demyelinating optic neuritis; MedDRA version: 16.0Level: PTClassification code 10030942Term: Optic neuritisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2011-003475-11-GB
• Lead Sponsor: niversity College London (UCL)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-24
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

a) A clinical diagnosis of acute unilateral optic neuritis (with or without a prior diagnosis of MS), with a visual acuity of = 6/9 (20/30) and an interval between onset of visual loss and randomization of = 14 days.
b) Age 18-60 years. The lower limit has been chosen so informed consent can be obtained, and the upper limit to avoid including participants with cerebrovascular disease, which would potentially influence the cerebral MRI appearances.
c) Gender. Men and women will be included, but we will perform an initial pregnancy test for women of childbearing age, who will be required to use appropriate methods of contraception during treatment with phenytoin and for 6 weeks afterwards to avoid any teratogenic effects of phenytoin.
d) Patients with a prior diagnosis of relapsing MS (whether or not being treated with Glatiramer Acetate or beta-Interferon) are eligible, if =10yr history of MS, and Extended Disability Status Score (EDSS) =3.
e) Considered able to comply with all study requirements.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

a) Any co-morbid ocular disease or previous history of optic neuritis in either eye, as this would interfere with the assessment of outcome.
b) Use of Na+ or Ca2+ channel blockers in the previous 2 weeks, corticosteroids in the previous 2 months, or immunosuppressive/immunomodulatory drugs (including natalizumab) in the previous 3 months.
c) Cardiac, hepatic or renal abnormalities, either in the clinical history or in screening blood tests. Screening ECG will be obtained, and patients with other major systemic diseases will also be excluded.
d) Past untoward reactions or other contraindications to phenytoin, or disabling temperature-dependent symptoms related to MS.
e) Contraindications to phenytoin, including concomitant medications.
f) Standard contraindications to MR imaging.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified