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Ampyra (Dalfampridine) - Summary

 
 



AMPYRA SUMMARY

AMPYRA (dalfampridine) is a potassium channel blocker, available in a 10 mg tablet strength.

AMPYRA (dalfampridine) is indicated as a treatment to improve walking in patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed [see Clinical Studies].


See all Ampyra indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Ampyra (Dalfampridine)

EMA Panel Backs Daclizumab (Zinbryta) for Multiple Sclerosis
Source: Medscape NeurologyHeadlines [2016.04.29]
Daclizumab, a once-monthly injection, offers a targeted mechanism of action that is not expected to cause broad and prolonged immune cell depletion.
International Approvals

From Vancouver, an Update on Multiple Sclerosis
Source: Medscape NeurologyHeadlines [2016.04.29]
Drs Krieger and Fox review some of the trends and outcomes in multiple sclerosis research at the American Academy of Neurology (AAN) 2016 Annual Meeting in Vancouver.
Medscape Neurology

Harsh out of necessity: To cope with Multiple Sclerosis, patients become morally stricter
Source: Anxiety / Stress News From Medical News Today [2016.04.29]
Multiple sclerosis (MS) can have a strong impact on the life of patients. Not only must they address the unpleasant symptoms, they are also subject to unpredictable relapses after more or less long...

Rituximab is superior to fingolimod for certain patients with multiple sclerosis
Source: Multiple Sclerosis News From Medical News Today [2016.04.22]
A new study indicates that rituximab is more effective than fingolimod for preventing relapses in patients with highly active multiple sclerosis switching from treatment with natalizumab.

Multiple sclerosis: 10-year follow-up data on Lemtrada (alemtuzumab) presented at the AAN 2016 Annual Meeting
Source: Clinical Trials / Drug Trials News From Medical News Today [2016.04.20]
Sanofi Genzyme, the specialty care global business unit of Sanofi, has announced that a new long-term analysis detailing 10 years of clinical efficacy of Lemtrada® (alemtuzumab) in people with...

more news >>

Published Studies Related to Ampyra (Dalfampridine)

Dalfampridine extended release: in multiple sclerosis. [2010.10.01]
Dalfampridine extended release (ER) is an orally administered formulation of dalfampridine (fampridine, 4-aminopyridine), a potassium channel antagonist indicated for the improvement in walking ability in patients with multiple sclerosis (MS). Oral dalfampridine ER improved walking ability in patients with MS in three randomized, double-blind trials of up to 15 weeks' duration...

A phase 3 trial of extended release oral dalfampridine in multiple sclerosis. [2010.10]
OBJECTIVE: A previous phase 3 study showed significant improvement in walking ability in multiple sclerosis (MS) patients treated with oral, extended-release dalfampridine (4-aminopyridine) 10mg twice daily. The current study was designed to confirm efficacy and further define safety and pharmacodynamics... INTERPRETATION: This interventional study provides class 1 evidence that dalfampridine extended-release tablets produce clinically meaningful improvement in walking ability in a subset of people with MS, with the effect maintained between doses.

A phase 3 trial of extended release oral dalfampridine in multiple sclerosis. [2010]
to confirm efficacy and further define safety and pharmacodynamics... INTERPRETATION: This interventional study provides class 1 evidence that

Dalfampridine: a brief review of its mechanism of action and efficacy as a treatment to improve walking in patients with multiple sclerosis. [2011.07]
BACKGROUND: Multiple sclerosis (MS) can cause progressive walking impairment that contributes to disability, loss of independence, and reduced quality of life. Dalfampridine (4-aminopyridine), a voltage-dependent potassium channel blocker, has been shown to improve walking in patients with MS, as demonstrated by an increase in walking speed. OBJECTIVE: To summarize knowledge about the mechanism of action of dalfampridine in the context of clinical evidence of walking improvement in MS patients... CONCLUSIONS: The extended-release formulation of dalfampridine has been shown in clinical trials to improve walking speed in approximately one third of MS patients with ambulatory impairment. The putative mechanism of action of dalfampridine is restoration of action potential conduction via blockade of an as yet uncharacterized subset of potassium channels in demyelinated axons.

Treatment of walking impairment in multiple sclerosis with dalfampridine. [2011.03]
Potassium channel blockade has long been considered a potential therapeutic strategy for treatment of multiple sclerosis (MS) based on the pathophysiology of demyelinated axons. Dalfampridine, which is also known as fampridine or 4-aminopyridine (4-AP), is the potassium channel blocker that has been studied most extensively in MS and other demyelinating neurologic disorders...

more studies >>

Clinical Trials Related to Ampyra (Dalfampridine)

Ampyra for Optic Neuritis in MS [Completed]
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.

A New Medicine to Treat Nonarteritic Anterior Ischemic Optic Neuropathy (NAION) [Active, not recruiting]
Determine whether dalfampridine (Ampyra) can improve visual function in patients who have had nonarteritic ischemic optic neuropathy (NAION) with stable visual impairment.

A Randomized Trial to Evaluate Ampyra for Gait Impairment in Parkinson's Disease [Completed]
The purpose of this study is to evaluate the effect of AMPYRA on a number of symptoms in Parkinson's disease. AMPYRA is a medication approved by FDA for gait dysfunction in multiple sclerosis. There are multiple studies to suggest that persons with multiple sclerosis benefit from this medication and have major improvements in gait after taking this medication. However, this medication was never studied in Parkinson's disease. This study aims to learn about possible benefits of AMPYRA in Parkinson's disease (PD).

An Open Label, Proof of Concept Study to Evaluate the Effects of Dalfampridine Withdrawal on Gait and Balance Parameters in Subjects With Multiple Sclerosis (MS) [Completed]
The purpose of this study is to determine changes on overall gait as well as in multiple gait and balance parameters after withdrawal of dalfampridine-ER 10mg in MS subjects who are receiving the medication consistently for at least two weeks prior to screening.

A Pharmacokinetics (PK) and Safety Study of Oral Fampridine-PR 10 mg in Chinese, Japanese, and Caucasian Adult Healthy Volunteers [Completed]

more trials >>

Reports of Suspected Ampyra (Dalfampridine) Side Effects

Convulsion (149)Fall (90)Gait Disturbance (64)Urinary Tract Infection (63)Abasia (57)Inappropriate Schedule of Drug Administration (57)Multiple Sclerosis Relapse (52)Dizziness (48)Asthenia (40)Nausea (37)more >>


Page last updated: 2016-04-29

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