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 range18 Years – 55 Years

SexALL

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

✕. Any ophthalmologic condition, other than ON, which can affect vision, including nystagmus in primary position of gaze,
✕. history of seizures or spells with altered level of consciousness,

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 range18 Years – 55 Years

SexALL

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

✕. Any ophthalmologic condition, other than ON, which can affect vision, including nystagmus in primary position of gaze,
✕. history of seizures or spells with altered level of consciousness,