Phase 3 N=46 Randomized Single-blind Treatment

Ampyra for Optic Neuritis in Multiple Sclerosis

Multiple Sclerosis · Optic Neuritis

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View on ClinicalTrials.gov: NCT01337986 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2020

Primary outcome: Primary: Efficacy of Dalfampridine on Visual Function by Early Diabetic Treatment Retinopathy Study (EDTRS) 5% Contrast Sensitivity Scores — -0.04; -0.06; -0.08; -0.06 LogMAR Score — p=0.84

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Dalfampridine/Placebo (Drug); Placebo/Dalfampridine (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Washington University School of Medicine
Primary completion: Dec 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Efficacy of Dalfampridine on Visual Function by Early Diabetic Treatment Retinopathy Study (EDTRS) 5% Contrast Sensitivity Scores	-0.04; -0.06; -0.08; -0.06	0.84
PRIMARY Efficacy of Dalfampridine on Visual Function Assessed by Change From Baseline in Raw Letters by EDTRS 5% Contrast Sensitivity	2; 2; 4; 3	—
PRIMARY Difference in EDTRS 5% Contrast Sensitivity (LogMAR Score) at Visits 2 and 3 Relative to Visit 1	0.06; 0.05	.64
PRIMARY Change From Baseline in Raw Letters by EDTRS 5% Contrast Sensitivity	3; 2.5	—
SECONDARY Percentage of Eyes That Improved by 2 Lines (10 Letters) on the Sloan 5% Contrast Sensitivity Chart	9.7; 11.1; 11.1; 68.1	0.93
SECONDARY Percentage of Eyes That Improved by One-line (5 Letters)	11.1; 15.3; 37.5; 36.1	.34
SECONDARY Visual Evoked Potential P100 Latency Per Treatment Arm	121.6; 120.2	—
SECONDARY Odds Ratio Quartile of Visual Field Index	77.53; 85.38; 78.50; 86.65; 79.71; 86.00	0.04 sig
SECONDARY Changes in Color Vision Total Error Score From Baseline Based Upon the Farnsworth Munsell Hue 100 Sort Test (FM100).	-13.0; -10.6	0.94
SECONDARY Dalfampridine Effect on Quality of Life Change From Baseline.	0; 0	0.39
SECONDARY Difference in Pelli- Robson Score at Visits 2 and 3 Relative to Visit 1	0.07; 0.06	0.72

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.

Eligibility Criteria

Inclusion criteria are:

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 are:

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,
pregnancy or breast feeding,
an MS exacerbation or use of glucocorticoids within 3 months of entry,
a history of moderate to severe renal insufficiency,
previous use of 4-aminopyridine, in any formulation, in the prior 4 weeks.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01337986). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.