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Ampyra for Optic Neuritis in Multiple Sclerosis

Primary Purpose

Multiple Sclerosis, Optic Neuritis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dalfampridine/Placebo
Placebo/Dalfampridine
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Optic Neuritis, Ampyra, Dalfampridine, Fampridine, Remote Optic Neuritis, Contrast Sensitivity, Treatment

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Washington University (John L. Trotter MS Center)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group B: Dalfampridine First

Group A: Dalfampridine Second

Arm Description

Dalfampridine/Placebo: Weeks 1-3: Dalfampridine 10mg (1 tablet) every 12 hours for 3 weeks. Weeks 4-5: 2 weeks of wash-out. Weeks 5-8: Placebo (sugar pill) 1 tablet every 12 hours for 3 weeks.

Placebo/Dalfampridine: Weeks 1-3: Placebo (sugar pill) 1 tablet every 12 hours for 3 weeks. Weeks 4-5: 2 weeks of wash-out. Weeks 6-8: Dalfampridine 10mg (1 tablet) every 12 hours for 3 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Percentage of Eyes That Improved by 2 Lines (10 Letters) on the Sloan 5% Contrast Sensitivity Chart
Percentage of Eyes That Improved by One-line (5 Letters)
Percentage of eyes that improved by one-line (5 letters) on the 5% contrast sensitivity chart
Visual Evoked Potential P100 Latency Per Treatment Arm
Visual evoked potential 60min P100 latency on dalfampridine vs. placebo.
Odds Ratio Quartile of Visual Field Index
The Visual Field Index (VFI) is a global index that assigns a number between 1% to 100% based on an aggregate percentage of visual function, with 100% being a perfect age-adjusted visual field. Probability of falling in the best quartile for visual field (VFI) measures (Q1), relative to the three next quartiles for worse VFIs (Q2-4), while on Dalfampridine vs Placebo. Due to the clustered observations at different times in a cross-over design, the visual field data is not suited to a normal theory model and should not be expressed as a continuous variable. Thus, a categorical model that uses a multinomial distribution for measurement of 4 categories was selected for proper statistical modeling, with results expressed as odds ratios.
Changes in Color Vision Total Error Score From Baseline Based Upon the Farnsworth Munsell Hue 100 Sort Test (FM100).
Dalfampridine will change color vision Total Error Scores from baseline on the Farnsworth Munsell 100 Hue Sort Test. Farnsworth Munsell 100 Hue Test requires placing 100 color palettes in the correct order based upon color hue. Scores are determined by the frequency and severity of any displacement in the correct order. One error equates to one misplaced hue, by one step or position. An error score greater than 500 indicates virtually no color discrimination. An error score of 0 indicates no errors in ordering the hues. A Total Error Score of 0 to 128 could be seen in a normal population.
Dalfampridine Effect on Quality of Life Change From Baseline.
Dalfampridine treatment will result in change in quality of life. The National Eye Institute Visual Function Questionnaire consists of 25 questions characterizing visual function at home and in the community. Score ranges from 100 (best) to 0 (worst).
Difference in Pelli- Robson Score at Visits 2 and 3 Relative to Visit 1
Difference in Pelli- Robson Score at Visits 2 and 3 Relative to Visit 1 on Dalfampridine vs Placebo. Pelli-Robson is scored based upon the numbers read on the chart converted to LogMAR units. The scale is 0.00 (worst) to 2.35 (best).

Full Information

First Posted
April 13, 2011
Last Updated
January 23, 2020
Sponsor
Washington University School of Medicine
Collaborators
Acorda Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT01337986
Brief Title
Ampyra for Optic Neuritis in Multiple Sclerosis
Official Title
Dalfampridine After Optic Neuritis to Improve Visual Function in Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
Acorda Therapeutics

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
Optic neuritis (ON) is the presenting feature of multiple sclerosis (MS) in 15% of cases, and occurs over the disease course in 50% of patients.1-3 Vision remains a major concern for MS patients, as visual dysfunction leads to lower quality of life.4-6 Despite the high prevalence of ON in MS, treatment and management options remain limited. Although intravenous glucocorticoids are employed to aid recovery of an acute episode of ON, no convincing evidence supports their efficacy in altering the degree of long-term recovery.7 Although some individuals with ON can have a dramatic recovery from blindness, ON often impairs visual function permanently. In the Optic Neuritis Treatment Trial, 63% reported that vision had not returned to normal after 6 months, and 20% had vision worse than 20/20 after 5 years of follow-up.8, 9 Visual impairment creates difficulties at home and work, leading to decreased independence and impaired mobility within the community. Visual dysfunction in combination with MS impairments within cerebellar and proprioceptive systems can be particularly disabling. Optic neuritis classically impairs one's ability to read print or a computer screen, to drive in bright or low light, and to appreciate colors and contrasts. Unfortunately, when optic neuritis results in lasting impairment, there are no pharmacologic therapies to restore vision. Low vision specialists may provide magnifying glasses, brighter lights, and advice to optimize the position of objects at home and in the workplace. Better treatment options are needed to improve visual function. Ampyra (dalfampridine) is a potassium-channel antagonist, with a mechanism-of-action to improve nerve conduction in demyelinated axons, resulting in an electrophysiologic and clinical benefit.10-22 Demyelinated axons within the anterior visual pathway would be a prime and ideal target to study the effects of Ampyra. In fact, Stefoski et al demonstrated visual function benefit in an open-label study of IV 4-aminopyridine in 12 subjects.21 The optic nerves are a well-defined white-matter tract, commonly affected in MS, and with clear clinical outcome measures. In addition, visual evoked potentials (VEPs) can be included within the study design as a secondary endpoint, to confirm improved nerve conduction. Because VEPs are such a precise, reliable, and accepted measure of demyelination, the anterior visual pathway is the ideal in vivo human system to study the electro-physiologic effects of a therapeutic such as Ampyra. Hypothesis 1: Dalfampridine treatment will improve visual function, measured by the 5% ETDRS contrast sensitivity chart, in subjects with long-term visual impairment secondary to optic neuritis from MS. Hypothesis 2: Dalfampridine treatment will reduce visual evoked potential P100 latency following remote optic neuritis. Hypothesis 3: Dalfampridine treatment will result in an improvement in secondary endpoints, including visual fields, high contrast visual acuity, color vision, and quality of life. The study will be conducted at the Department of Neurology and Neurosurgery, Washington University School of Medicine, St. Louis, the institution at which Dr. Naismith is based. The MS patients will come from the 1800 active MS patients in our clinic and the 3500 in the St. Louis area. Fifty subjects will be enrolled in this Phase II, investigator-initiated, randomized and blinded cross-over trial of dalfampridine of 8 weeks duration (Table 1). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Optic Neuritis
Keywords
Multiple Sclerosis, Optic Neuritis, Ampyra, Dalfampridine, Fampridine, Remote Optic Neuritis, Contrast Sensitivity, Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group B: Dalfampridine First
Arm Type
Active Comparator
Arm Description
Dalfampridine/Placebo: Weeks 1-3: Dalfampridine 10mg (1 tablet) every 12 hours for 3 weeks. Weeks 4-5: 2 weeks of wash-out. Weeks 5-8: Placebo (sugar pill) 1 tablet every 12 hours for 3 weeks.
Arm Title
Group A: Dalfampridine Second
Arm Type
Active Comparator
Arm Description
Placebo/Dalfampridine: Weeks 1-3: Placebo (sugar pill) 1 tablet every 12 hours for 3 weeks. Weeks 4-5: 2 weeks of wash-out. Weeks 6-8: Dalfampridine 10mg (1 tablet) every 12 hours for 3 weeks
Intervention Type
Drug
Intervention Name(s)
Dalfampridine/Placebo
Other Intervention Name(s)
Ampyra (R), Fampridine
Intervention Description
Weeks 1-3: Dalfampridine 10mg (1 tablet) every 12 hours for 3 weeks. Weeks 4-5: 2 weeks of wash-out. Weeks 5-8: Placebo (sugar pill) 1 tablet every 12 hours for 3 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo/Dalfampridine
Other Intervention Name(s)
Ampyra (R), Fampridine
Intervention Description
Weeks 1-3: Placebo (sugar pill) 1 tablet every 12 hours for 3 weeks. Weeks 4-5: 2 weeks of wash-out. Weeks 6-8: Dalfampridine 10mg (1 tablet) every 12 hours for 3 weeks.
Primary Outcome Measure Information:
Title
Efficacy of Dalfampridine on Visual Function by Early Diabetic Treatment Retinopathy Study (EDTRS) 5% Contrast Sensitivity Scores
Description
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.
Time Frame
Visit 1 (Week 0), Visit 2 (Week 3) and Visit 3 (Week 8)
Title
Efficacy of Dalfampridine on Visual Function Assessed by Change From Baseline in Raw Letters by EDTRS 5% Contrast Sensitivity
Description
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
Time Frame
Visit 1 (Week 0), Visit 2 (Week 3) and Visit 3 (Week 8)
Title
Difference in EDTRS 5% Contrast Sensitivity (LogMAR Score) at Visits 2 and 3 Relative to Visit 1
Description
Intent to treat analysis of treatment effect in primary endpoint EDTRS 5% Contrast Sensitivity. Improvement from baseline scores.
Time Frame
Visit 1 (Week 0), Visit 2 (Week 3) and Visit 3 (Week 8)
Title
Change From Baseline in Raw Letters by EDTRS 5% Contrast Sensitivity
Description
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.
Time Frame
Visit 1 (Week 0), Visit 2 (Week 3) and Visit 3 (Week 8)
Secondary Outcome Measure Information:
Title
Percentage of Eyes That Improved by 2 Lines (10 Letters) on the Sloan 5% Contrast Sensitivity Chart
Time Frame
Visit 1 (Week 0), Visit 2 (Week 3) and Visit 3 (Week 8)
Title
Percentage of Eyes That Improved by One-line (5 Letters)
Description
Percentage of eyes that improved by one-line (5 letters) on the 5% contrast sensitivity chart
Time Frame
Visit 1 (Week 0), Visit 2 (Week 3) and Visit 3 (Week 8)
Title
Visual Evoked Potential P100 Latency Per Treatment Arm
Description
Visual evoked potential 60min P100 latency on dalfampridine vs. placebo.
Time Frame
Visit 1 (Week 0), Visit 2 (Week 3) and Visit 3 (Week 8)
Title
Odds Ratio Quartile of Visual Field Index
Description
The Visual Field Index (VFI) is a global index that assigns a number between 1% to 100% based on an aggregate percentage of visual function, with 100% being a perfect age-adjusted visual field. Probability of falling in the best quartile for visual field (VFI) measures (Q1), relative to the three next quartiles for worse VFIs (Q2-4), while on Dalfampridine vs Placebo. Due to the clustered observations at different times in a cross-over design, the visual field data is not suited to a normal theory model and should not be expressed as a continuous variable. Thus, a categorical model that uses a multinomial distribution for measurement of 4 categories was selected for proper statistical modeling, with results expressed as odds ratios.
Time Frame
Visit 1 (Week 0 - baseline), Visit 2 (Week 3 - post intervention 1) and Visit 3 (Week 8 - post intervention 2)
Title
Changes in Color Vision Total Error Score From Baseline Based Upon the Farnsworth Munsell Hue 100 Sort Test (FM100).
Description
Dalfampridine will change color vision Total Error Scores from baseline on the Farnsworth Munsell 100 Hue Sort Test. Farnsworth Munsell 100 Hue Test requires placing 100 color palettes in the correct order based upon color hue. Scores are determined by the frequency and severity of any displacement in the correct order. One error equates to one misplaced hue, by one step or position. An error score greater than 500 indicates virtually no color discrimination. An error score of 0 indicates no errors in ordering the hues. A Total Error Score of 0 to 128 could be seen in a normal population.
Time Frame
Visit 1 (Week 0 - baseline), Visit 2 (Week 3 - postintervention 1) and Visit 3 (Week 8 - post intervention 2)
Title
Dalfampridine Effect on Quality of Life Change From Baseline.
Description
Dalfampridine treatment will result in change in quality of life. The National Eye Institute Visual Function Questionnaire consists of 25 questions characterizing visual function at home and in the community. Score ranges from 100 (best) to 0 (worst).
Time Frame
Visit 1 (Week 0), Visit 2 (Week 3) and Visit 3 (Week 8)
Title
Difference in Pelli- Robson Score at Visits 2 and 3 Relative to Visit 1
Description
Difference in Pelli- Robson Score at Visits 2 and 3 Relative to Visit 1 on Dalfampridine vs Placebo. Pelli-Robson is scored based upon the numbers read on the chart converted to LogMAR units. The scale is 0.00 (worst) to 2.35 (best).
Time Frame
Visit 1 (Week 0), Visit 2 (Week 3) and Visit 3 (Week 8)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert T Naismith, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University (John L. Trotter MS Center)
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Ampyra for Optic Neuritis in Multiple Sclerosis

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