Ampyra for Optic Neuritis in MS

This study has been completed.

Sponsor:

Collaborator:

Acorda Therapeutics

Information provided by (Responsible Party):

Robert Naismith, Washington University School of Medicine

ClinicalTrials.gov Identifier:

NCT01337986

First received: April 13, 2011

Last updated: February 14, 2014

Last verified: February 2014

History of Changes

Purpose

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	Intervention	Phase
Multiple Sclerosis Optic Neuritis	Drug: Dalfampridine/Placebo Drug: Placebo/Dalfampridine	Phase 2 Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single Blind (Participant) Primary Purpose: Treatment
Official Title:	Dalfampridine After Optic Neuritis to Improve Visual Function in Multiple Sclerosis

Resource links provided by NLM:

Genetics Home Reference related topics: multiple sclerosis

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Dalfampridine

Genetic and Rare Diseases Information Center resources: Optic Neuritis

U.S. FDA Resources

Further study details as provided by Robert Naismith, Washington University School of Medicine:

Primary Outcome Measures:

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:

Dalfampridine reduce visual evoked potential P100 latency. [ Time Frame: 8 weeks ]
Dalfampridine treatment will reduce visual evoked potential P100 latency following remote optic neuritis.
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.
Dalfampridine affect on quality of life. [ Time Frame: 8 weeks ]
Dalfampridine treatment will result in an improvement quality of life.


Enrollment:	53
Study Start Date:	May 2011
Study Completion Date:	December 2013
Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Show Detailed Description

Eligibility


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

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Publications:

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Naismith RT, Tutlam NT, Xu J, Shepherd JB, Klawiter EC, Song SK, Cross AH. Optical coherence tomography is less sensitive than visual evoked potentials in optic neuritis. Neurology. 2009 Jul 7;73(1):46-52. doi: 10.1212/WNL.0b013e3181aaea32.

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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 )
Study First Received:	April 13, 2011
Last Updated:	February 14, 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 Optic Neuritis Neuritis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases	Immune System Diseases Optic Nerve Diseases Cranial Nerve Diseases Eye Diseases Peripheral Nervous System Diseases Neuromuscular Diseases 4-Aminopyridine Potassium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 22, 2017

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