Ampyra for Optic Neuritis in MS
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Washington University School of Medicine.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Washington University School of Medicine
Collaborator:
Acorda Therapeutics
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01337986
First received: April 13, 2011
Last updated: May 13, 2011
Last verified: May 2011
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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 Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) 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
U.S. FDA Resources
Further study details as provided by Washington University School of Medicine:
Primary Outcome Measures:
- Efficacy of Dalfampridine on visual function (contrast sensitivity). [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Dalfampridine treatment will result in an improvement quality of life.
| Estimated Enrollment: | 50 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | March 2012 (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:
|
| 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:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| 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 18-55,
- visual acuity greater than or equal to 20/30 but less than or equal to 20/200,
- must be able to read at least 2 of the 5 letters on the top line of the 5% ETDRS chart (logMAR 0.96), 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01337986
Contacts
| Contact: Samantha L Lancia, MS | 314-747-5576 | lancias@neuro.wustl.edu |
| Contact: Nhial Tutlam, MPH | 314-362-3402 | tutlamn@neuro.wustl.edu |
Locations
| United States, Missouri | |
| Washington University (John L. Trotter MS Center) | Recruiting |
| St. Louis, Missouri, United States, 63110 | |
| Contact: Samantha L Lancia, MS 314-747-5576 lancias@neuro.wustl.edu | |
| Contact: Nhial Tutlam, MPH 314-362-3402 tutlamn@neuro.wustl.edu | |
| Principal Investigator: Robert T Naismith, MD | |
Sponsors and Collaborators
Washington University School of Medicine
Acorda Therapeutics
Investigators
| Principal Investigator: | Robert T Naismith, MD | Washington University School of Medicine |
More Information
Additional Information:
Publications:
Farnsworth D. The Farnsworth-Munsell 100-hue and dichotomous tests for color vision. J Opt Soc Am 1943;33:568-574.
| Responsible Party: | Robert T. Naismith, MD, Washington University |
| ClinicalTrials.gov Identifier: | NCT01337986 History of Changes |
| Other Study ID Numbers: | Ampyra Vision 2011 RTN, WU HRPO# : 201104126 |
| Study First Received: | April 13, 2011 |
| Last Updated: | May 13, 2011 |
| Health Authority: | United States: Institutional Review Board |
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:
|
Multiple Sclerosis Neuritis Optic Neuritis Sclerosis 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 Pathologic Processes 4-Aminopyridine Potassium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013