CompletedPhase 2/3

Ampyra for Optic Neuritis in Multiple Sclerosis

United States53 participantsStarted 2011-05

Plain-language 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.

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. At least one previous clinical episode of optic neuritis,
. the last episode of ON must have occurred at least 12 months prior to study entry,
. clinically definite MS, defined by the revised McDonald criteria, 23
. ages 18-70,
. visual acuity greater than or equal to 20/30
. 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
. must have sufficient cognitive function to understand the consent process and to reliably perform all clinical assessments

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Efficacy of Dalfampridine on Visual Function by Early Diabetic Treatment Retinopathy Study (EDTRS) 5% Contrast Sensitivity Scores

Timeframe: Visit 1 (Week 0), Visit 2 (Week 3) and Visit 3 (Week 8)

Efficacy of Dalfampridine on Visual Function Assessed by Change From Baseline in Raw Letters by EDTRS 5% Contrast Sensitivity

Timeframe: Visit 1 (Week 0), Visit 2 (Week 3) and Visit 3 (Week 8)

Difference in EDTRS 5% Contrast Sensitivity (LogMAR Score) at Visits 2 and 3 Relative to Visit 1

Timeframe: Visit 1 (Week 0), Visit 2 (Week 3) and Visit 3 (Week 8)

Change From Baseline in Raw Letters by EDTRS 5% Contrast Sensitivity

Timeframe: Visit 1 (Week 0), Visit 2 (Week 3) and Visit 3 (Week 8)

Trial details

NCT IDNCT01337986

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-12

Results submitted2016-05-04

View on ClinicalTrials.gov More Multiple Sclerosis trials

Plain-language summary

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. At least one previous clinical episode of optic neuritis,
. the last episode of ON must have occurred at least 12 months prior to study entry,
. clinically definite MS, defined by the revised McDonald criteria, 23
. ages 18-70,
. visual acuity greater than or equal to 20/30
. 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
. must have sufficient cognitive function to understand the consent process and to reliably perform all clinical assessments