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Generated: February 19, 2019

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CLINICAL TRIALS PROFILE FOR AMPYRA

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Clinical Trials for Ampyra

Trial ID Title Status Sponsor Phase Summary
NCT01235221 Open Label Extension Study to Evaluate the Safety and Tolerability of Oral Fampridine-Sustained Release (SR) in Canadian Participants With Multiple Sclerosis Who Participated in Acorda Extension Trials. Completed Acorda Therapeutics Phase 3 The primary objective of the study is to evaluate the long-term safety and tolerability of BIIB041 (fampridine-sustained release (SR)) treatment in Canadian participants with multiple sclerosis (MS) who previously participated in the registrational and extension studies conducted by Acorda. Those studies include NCT00654927 (MS-F202EXT), NCT00648908 (MS-F203EXT) and NCT00649792 (MS-F204EXT).
NCT01235221 Open Label Extension Study to Evaluate the Safety and Tolerability of Oral Fampridine-Sustained Release (SR) in Canadian Participants With Multiple Sclerosis Who Participated in Acorda Extension Trials. Completed Biogen Phase 3 The primary objective of the study is to evaluate the long-term safety and tolerability of BIIB041 (fampridine-sustained release (SR)) treatment in Canadian participants with multiple sclerosis (MS) who previously participated in the registrational and extension studies conducted by Acorda. Those studies include NCT00654927 (MS-F202EXT), NCT00648908 (MS-F203EXT) and NCT00649792 (MS-F204EXT).
NCT01337986 Ampyra for Optic Neuritis in MS Completed Acorda Therapeutics Phase 2/Phase 3 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.
NCT01337986 Ampyra for Optic Neuritis in MS Completed Washington University School of Medicine Phase 2/Phase 3 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.
NCT01444300 Dalfampridine for Imbalance in Multiple Sclerosis Completed Acorda Therapeutics Phase 2 Dalfampridine is a new medication that was FDA approved in 2010 to improve walking speed in people with Multiple Sclerosis (MS). People with MS walk slowly in part because MS damages the myelin insulation around nerves which slows conduction of messages from the brain to the leg muscles. Dalfampridine works by improving conduction in nerves with damaged myelin. Recent research indicates that imbalance in MS is in large part caused by poor conduction by the nerves that transmit information about the position of the legs to the brain. It is therefore likely that, by improving nerve conduction, dalfampridine will also improve imbalance in people with MS. Dalfampridine will be administered in this study by the same route (oral), dosage (10mg), and frequency (every 12 hours) approved by the FDA to improve walking speed in people with MS. The proposed pilot study will examine the effects of dalfampridine on imbalance in 24 subjects with Multiple Sclerosis (MS) and imbalance. This small pilot study will help to show if dalfampridine improves imbalance in MS and will guide the design and implementation of a larger full scale study to definitively determine if dalfampridine improves balance and prevents falls in people with MS.
NCT01444300 Dalfampridine for Imbalance in Multiple Sclerosis Completed Oregon Health and Science University Phase 2 Dalfampridine is a new medication that was FDA approved in 2010 to improve walking speed in people with Multiple Sclerosis (MS). People with MS walk slowly in part because MS damages the myelin insulation around nerves which slows conduction of messages from the brain to the leg muscles. Dalfampridine works by improving conduction in nerves with damaged myelin. Recent research indicates that imbalance in MS is in large part caused by poor conduction by the nerves that transmit information about the position of the legs to the brain. It is therefore likely that, by improving nerve conduction, dalfampridine will also improve imbalance in people with MS. Dalfampridine will be administered in this study by the same route (oral), dosage (10mg), and frequency (every 12 hours) approved by the FDA to improve walking speed in people with MS. The proposed pilot study will examine the effects of dalfampridine on imbalance in 24 subjects with Multiple Sclerosis (MS) and imbalance. This small pilot study will help to show if dalfampridine improves imbalance in MS and will guide the design and implementation of a larger full scale study to definitively determine if dalfampridine improves balance and prevents falls in people with MS.
NCT01446575 Safety and Efficacy of Sustained Release Dalfampridine in Transverse Myelitis Terminated Acorda Therapeutics Phase 4 Transverse myelitis is an inflammatory disorder of the spinal cord that leads to disabilities of gait. Dalfampridine, a sustained-release potassium channel blocker that has been shown to be effective in improving gait and other neurologic functions in multiple sclerosis. Dalfampridine has the potential to improve gait and neurologic function in patients with transverse myelitis as this rare disorder shares a similar pathogenic process with multiple sclerosis. The investigators propose a clinical trial to test the efficacy of dalfampridine in this particular cohort of patients. The clinical trial that the investigators propose to conduct will focus on monophasic idiopathic Transverse Myelitis (TM) and will evaluate the efficacy of dalfampridine in primary neurologic outcome, 25-foot timed walk, and several secondary outcomes including valid behavioral and neurophysiological measures. To better understand the mechanisms underlying the proposed behavioral gains, the investigators will use Transcranial Magnetic Stimulation as the neurophysiologic measure to identify changes in corticomotor excitability in the spinal cord.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Ampyra

Condition Name

Condition Name for Ampyra
Intervention Trials
Multiple Sclerosis 9
Transverse Myelitis 2
Relapsing-Remitting Multiple Sclerosis 1
Fatigue 1
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Condition MeSH

Condition MeSH for Ampyra
Intervention Trials
Sclerosis 9
Multiple Sclerosis 9
Myelitis, Transverse 2
Myelitis 2
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Clinical Trial Locations for Ampyra

Trials by Country

Trials by Country for Ampyra
Location Trials
United States 55
United Kingdom 13
France 11
Canada 9
Spain 6
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Trials by US State

Trials by US State for Ampyra
Location Trials
New York 6
Florida 5
California 3
Maryland 3
Missouri 3
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Clinical Trial Progress for Ampyra

Clinical Trial Phase

Clinical Trial Phase for Ampyra
Clinical Trial Phase Trials
Phase 4 4
Phase 3 4
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Ampyra
Clinical Trial Phase Trials
Completed 11
Active, not recruiting 2
Unknown status 2
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Clinical Trial Sponsors for Ampyra

Sponsor Name

Sponsor Name for Ampyra
Sponsor Trials
Acorda Therapeutics 10
Biogen 5
Johns Hopkins University 2
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Sponsor Type

Sponsor Type for Ampyra
Sponsor Trials
Other 16
Industry 15
U.S. Fed 1
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