NCT01337986

Dalfampridine After Optic Neuritis to Improve Visual Function in Multiple Sclerosis

Completed Phase 2/Phase 3 Results posted Last updated 23 January 2020

What this trial tests

Phase 2/Phase 3 trial testing Dalfampridine/Placebo in Multiple Sclerosis in 53 participants. Completed in 1 December 2013.

Timeline

1 May 2011

Primary endpoint
1 December 2013

1 December 2013

Quick facts

Lead sponsor	Washington University School of Medicine
Phase	Phase 2/Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	treatment
Enrollment	53
Start date	1 May 2011
Primary completion	1 December 2013
Estimated completion	1 December 2013
Sites	1 location across United States

Drugs / interventions tested

• Dalfampridine/Placebo — full drug profile →
• Placebo/Dalfampridine — full drug profile →

Conditions studied

• Multiple Sclerosis — all drugs for Multiple Sclerosis →
• Optic Neuritis — all drugs for Optic Neuritis →

Sponsor

Washington University School of Medicine

Who can join

Adults 18 to 55, any sex, with Multiple Sclerosis or Optic Neuritis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Efficacy of Dalfampridine on Visual Function by Early Diabetic Treatment Retinopathy Study (EDTRS) 5% Contrast Sensitivity Scores
  Time frame: Visit 1 (Week 0), Visit 2 (Week 3) and Visit 3 (Week 8)
  Per Protocol Analysis to assess differences in EDTRS 5% Contrast Sensitivity (LogMAR) Scores at visits 2 and 3 Relative to Visit 1 on patients taking Dalfampridine vs Placebo.
• Efficacy of Dalfampridine on Visual Function Assessed by Change From Baseline in Raw Letters by EDTRS 5% Contrast Sensitivity
  Time frame: Visit 1 (Week 0), Visit 2 (Week 3) and Visit 3 (Week 8)
  Per Protocol Analysis to assess difference in number of letters on the EDTRS 5% Contrast Sensitivity (LogMAR) Chart scores at visits 2 and 3 Relative to Visit 1
• Difference in EDTRS 5% Contrast Sensitivity (LogMAR Score) at Visits 2 and 3 Relative to Visit 1
  Time frame: Visit 1 (Week 0), Visit 2 (Week 3) and Visit 3 (Week 8)
  Intent to treat analysis of treatment effect in primary endpoint EDTRS 5% Contrast Sensitivity. Improvement from baseline scores.
• Change From Baseline in Raw Letters by EDTRS 5% Contrast Sensitivity
  Time frame: Visit 1 (Week 0), Visit 2 (Week 3) and Visit 3 (Week 8)
  Intent to treat analysis of treatment effect in primary endpoint EDTRS 5% Contrast Sensitivity. Change in the number of letters able to read while on Dalfampridine and Placebo relative to their baseline scores.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Leveraging Visual Outcome Measures to Advance Therapy Development in Neuroimmunologic Disorders.
   Graves JS, Oertel FC, Van der Walt A, Collorone S, et al · · 2022 · cited 45× · PMID 34955459 · DOI 10.1212/nxi.0000000000001126