Ampyra for Optic Neuritis in Multiple Sclerosis

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Fifty subjects will be enrolled in this Phase II, investigator-initiated, randomized and blinded cross-over trial of dalfampridine of 8 weeks duration The study will test the hypothesis that dalfampridine, when administered to subjects with incomplete visual recovery after optic neuritis from MS, will result in symptomatic improvement in visual function. The study will consist of one screening/baseline visit, one visit during treatment with active drug, and one visit on placebo. After the baseline visit, subjects will be randomly assigned to receive study medication or placebo for the first three weeks, followed by a two week wash-out, and then treatment reallocation for the latter three weeks.

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

Details

• Lead Sponsor: Washington University School of Medicine
• Collaborator: Acorda Therapeutics
• Treatments: 4-Aminopyridine

Criteria

Inclusion criteria are:

1. At least one previous clinical episode of optic neuritis,

2. the last episode of ON must have occurred at least 12 months prior to study entry,

3. clinically definite MS, defined by the revised McDonald criteria, 23

4. ages 18-70,

5. visual acuity greater than or equal to 20/30

6. must be able to read at least 2 of the 5 letters on the top line of the 5% ETDRS chart (logMAR 0.96) at 3 meters, 2 meters or 1 meter, and

7. must have sufficient cognitive function to understand the consent process and to reliably perform all clinical assessments

Exclusion criteria are:

1. Any ophthalmologic condition, other than ON, which can affect vision, including nystagmus in primary position of gaze,

2. history of seizures or spells with altered level of consciousness,

3. pregnancy or breast feeding,

4. an MS exacerbation or use of glucocorticoids within 3 months of entry,

5. a history of moderate to severe renal insufficiency,

6. previous use of 4-aminopyridine, in any formulation, in the prior 4 weeks.