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Ampyra for Optic Neuritis in MS

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ClinicalTrials.gov Identifier: NCT01337986
Recruitment Status : Completed
First Posted : April 19, 2011
Last Update Posted : February 19, 2014
Sponsor:
Collaborator:
Acorda Therapeutics
Information provided by (Responsible Party):
Robert Naismith, Washington University School of Medicine

Study Description
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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 Design
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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

U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Group A: Dalfampridine/Placebo 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 B: Placebo/Dalfampridine 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


Outcome Measures
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Primary Outcome Measures :
  1. Efficacy of Dalfampridine on visual function (contrast sensitivity). [ Time Frame: 8 weeks ]
    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.


Secondary Outcome Measures :
  1. Dalfampridine reduce visual evoked potential P100 latency. [ Time Frame: 8 weeks ]
    Dalfampridine treatment will reduce visual evoked potential P100 latency following remote optic neuritis.

  2. Dalfampridine improvement in other vision testing (acuity, color, and fields). [ Time Frame: 8 weeks ]
    Dalfampridine treatment will result in an improvement in visual fields, high contrast visual acuity, and color vision.

  3. Dalfampridine affect on quality of life. [ Time Frame: 8 weeks ]
    Dalfampridine treatment will result in an improvement quality of life.


Eligibility Criteria
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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.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
United States, Missouri
Washington University (John L. Trotter MS Center)
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Acorda Therapeutics
Investigators
Principal Investigator: Robert T Naismith, MD Washington University School of Medicine
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
John L. Trotter MS Center, Washington University School of Medicine & Barnes Jewish Hospital  This link exits the ClinicalTrials.gov site

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).

Responsible Party: Robert Naismith, Assistant Professor of Neurology, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01337986     History of Changes
Other Study ID Numbers: Ampyra Vision 2011 RTN
WU HRPO# : 201104126 ( Other Identifier: Washington University HRPO )
First Posted: April 19, 2011    Key Record Dates
Last Update Posted: February 19, 2014
Last Verified: February 2014

Keywords provided by Robert Naismith, Washington University School of Medicine:
Multiple Sclerosis
Optic Neuritis
Ampyra
Dalfampridine
 Fampridine
Remote Optic Neuritis
Contrast Sensitivity
Treatment

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Neuritis
Optic Neuritis
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