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Ampyra for Optic Neuritis in Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01337986
Recruitment Status : Completed
First Posted : April 19, 2011
Results First Posted : January 30, 2020
Last Update Posted : January 30, 2020
Sponsor:
Collaborator:
Acorda Therapeutics
Information provided by (Responsible Party):
Washington University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Optic Neuritis Drug: Dalfampridine/Placebo Drug: Placebo/Dalfampridine Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Dalfampridine After Optic Neuritis to Improve Visual Function in Multiple Sclerosis
Study Start Date : May 2011
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group B: Dalfampridine First
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.
Drug: 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.
Other Names:
  • Ampyra (R)
  • Fampridine

Active Comparator: Group A: Dalfampridine Second
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
Drug: 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.
Other Names:
  • Ampyra (R)
  • Fampridine




Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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) ]
  2. Percentage of Eyes That Improved by One-line (5 Letters) [ Time Frame: Visit 1 (Week 0), Visit 2 (Week 3) and Visit 3 (Week 8) ]
    Percentage of eyes that improved by one-line (5 letters) on the 5% contrast sensitivity chart

  3. Visual Evoked Potential P100 Latency Per Treatment Arm [ Time Frame: Visit 1 (Week 0), Visit 2 (Week 3) and Visit 3 (Week 8) ]
    Visual evoked potential 60min P100 latency on dalfampridine vs. placebo.

  4. Odds Ratio Quartile of Visual Field Index [ Time Frame: Visit 1 (Week 0 - baseline), Visit 2 (Week 3 - post intervention 1) and Visit 3 (Week 8 - post intervention 2) ]

    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.


  5. Changes in Color Vision Total Error Score From Baseline Based Upon the Farnsworth Munsell Hue 100 Sort Test (FM100). [ Time Frame: Visit 1 (Week 0 - baseline), Visit 2 (Week 3 - postintervention 1) and Visit 3 (Week 8 - post intervention 2) ]
    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.

  6. Dalfampridine Effect on Quality of Life Change From Baseline. [ Time Frame: Visit 1 (Week 0), Visit 2 (Week 3) and Visit 3 (Week 8) ]
    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).

  7. Difference in Pelli- Robson 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) ]
    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).



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01337986


Locations
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United States, Missouri
Washington University (John L. Trotter MS Center)
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Acorda Therapeutics
Investigators
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Principal Investigator: Robert T Naismith, MD Washington University School of Medicine
Publications:
Farnsworth D. The Farnsworth-Munsell 100-hue and dichotomous tests for color vision. J Opt Soc Am 1943;33:568-574.
Acorda Therapeutics. AMPRYA package insert (2010).

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01337986    
Other Study ID Numbers: Ampyra Vision 2011 RTN
WU HRPO# : 201104126 ( Other Identifier: Washington University HRPO )
First Posted: April 19, 2011    Key Record Dates
Results First Posted: January 30, 2020
Last Update Posted: January 30, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Washington University School of Medicine:
Multiple Sclerosis
Optic Neuritis
Ampyra
Dalfampridine
Fampridine
Remote Optic Neuritis
Contrast Sensitivity
Treatment
Additional relevant MeSH terms:
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Multiple Sclerosis
Neuritis
Optic Neuritis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Optic Nerve Diseases
Cranial Nerve Diseases
Eye Diseases
4-Aminopyridine
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action