CLINICAL TRIALS PROFILE FOR AMPYRA

All Clinical Trials for Ampyra

Trial ID	Title	Status	Sponsor	Phase	Start Date	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	2010-12-01	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	2010-12-01	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 Multiple Sclerosis	Completed	Acorda Therapeutics	Phase 2/Phase 3	2011-05-01	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 Multiple Sclerosis	Completed	Washington University School of Medicine	Phase 2/Phase 3	2011-05-01	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	2011-09-01	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	2011-09-01	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.

Clinical Trial Conditions for Ampyra

Condition Name

Condition Name for Ampyra
Intervention	Trials
Multiple Sclerosis	10
Transverse Myelitis	2
Idiopathic Transverse Myelitis	2
Myelitis NOS	2

Condition MeSH

Condition MeSH for Ampyra
Intervention	Trials
Sclerosis	10
Multiple Sclerosis	10
Neuromyelitis Optica	2
Wounds and Injuries	2

Clinical Trial Locations for Ampyra

Trials by Country

Trials by Country for Ampyra
Location	Trials
United States	59
France	14
United Kingdom	13
Canada	12
Germany	12

Trials by US State

Trials by US State for Ampyra
Location	Trials
New York	6
Florida	6
Massachusetts	4
Pennsylvania	3
California	3

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	4

Clinical Trial Status

Clinical Trial Status for Ampyra
Clinical Trial Phase	Trials
Completed	16
Recruiting	2
Not yet recruiting	1

Clinical Trial Sponsors for Ampyra

Sponsor Name

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

Sponsor Type

Sponsor Type for Ampyra
Sponsor	Trials
Other	18
Industry	15
U.S. Fed	2

Ampyra (Dalfampridine): Clinical Trials, Market Analysis, and Projections

Introduction to Ampyra

Ampyra, known generically as dalfampridine, is a potassium channel blocker designed to enhance conduction in damaged nerves. It is specifically indicated for improving walking in patients with multiple sclerosis (MS)[1].

Clinical Trials Overview

The FDA approval of Ampyra was based on two significant clinical trials.

Trial One

This 21-week, randomized, placebo-controlled study involved 301 patients with MS at 33 centers in the U.S. and Canada. Patients were assigned to either Ampyra 10 mg twice daily or a placebo. The primary measure of efficacy was walking speed, as measured by the Timed 25-foot Walk (T25W). The results showed that 34.8% of patients taking Ampyra were responders, compared to 8.3% of those taking the placebo. This significant improvement was observed across all four major types of MS disease courses[1].

Trial Two

This 14-week study enrolled 239 patients with MS at 39 centers in the U.S. and Canada. Similar to the first trial, patients were assigned to either Ampyra 10 mg twice daily or a placebo. The primary endpoint was again walking speed measured by the T25W. Here, 42.9% of patients taking Ampyra were responders, compared to 9.3% of those on the placebo. This trial also showed significant improvements in walking speed across all MS disease courses[1].

Additional Clinical Findings

Post-Marketing Studies

A post-marketing study requested by the FDA to assess the safety and efficacy of a lower dose (5 mg twice daily) of Ampyra did not show improvement in walking speed compared to the approved 10 mg dose. The 10 mg dose still significantly improved walking speed in responders, but the 5 mg dose did not. This study also highlighted the importance of adhering to the recommended dosage to avoid adverse events such as seizures, particularly in patients with kidney impairment[4].

Mechanism of Action

Ampyra works by blocking potassium channels, although the exact mechanism by which it exerts its therapeutic effect is not fully understood. It is available as an extended-release tablet for twice-daily oral administration, with a maximum recommended dose of one 10 mg tablet twice daily[1].

Market Analysis

Current Market Performance

Ampyra's market performance has been declining since the introduction of generic versions in 2018. In 2022, Ampyra generated $72.9 million in revenue, a 13% decline from the previous year. Biogen's sales of Fampyra (the European version of Ampyra) also peaked at $105.2 million in 2021 and slipped to $96.6 million in 2022[5].

Market Share

As of recent reports, Ampyra holds approximately 15% of the dalfampridine market. However, its market share is expected to continue declining, stabilizing at around 10% of peak sales through 2027[2].

Competitive Landscape

The entry of generic competitors has significantly impacted Ampyra's sales. Despite this, Acorda Therapeutics continues to promote the brand, and there has been a resurgence in prescriptions from about 200 healthcare professionals in 2022. Approximately 70% of all covered lives have access to Ampyra, indicating continued support from payers[2].

Projections and Future Outlook

Sales Projections

Given the competitive pressure from generics, Ampyra's sales are expected to continue their downward trend. However, Acorda Therapeutics anticipates that the brand will stabilize at a lower level, with long-term value projected at around 10% of peak sales through 2027[2].

Strategic Focus

Acorda Therapeutics is focusing on other products, such as INBRIJA, which is expected to grow in the U.S. and expand into additional international markets. This strategic shift aims to offset the declining sales of Ampyra and ensure the company's financial stability[2].

Safety and Side Effects

Ampyra is associated with several adverse events, including urinary tract infections, insomnia, dizziness, headache, nausea, asthenia, back pain, balance disorder, multiple sclerosis relapse, paresthesia, nasopharyngitis, constipation, dyspepsia, and pharyngolaryngeal pain. It is crucial for patients to follow the prescribed dosage and monitor their kidney function to minimize the risk of seizures and other serious adverse events[1][4].

Patient Impact

Clinical Meaningfulness

Patients have reported significant improvements in their walking ability using Ampyra, as measured by the 12-item Multiple Sclerosis Walking Scale (MSWS-12). This patient-based assessment highlights the clinical meaningfulness of the improved walking speeds observed in clinical trials[3].

Real-World Experience

Thousands of patients in the U.S. and other countries have experienced improvements in their walking since initiating therapy with Ampyra. The drug has filled a significant unmet medical need for MS patients, offering a novel therapeutic option to enhance their mobility[3].

Key Takeaways

• Ampyra is approved for improving walking in adults with multiple sclerosis.
• Clinical trials have shown significant improvements in walking speed compared to placebo.
• The drug faces declining sales due to generic competition.
• Acorda Therapeutics is focusing on stabilizing Ampyra's market share and shifting focus to other products.
• Patient safety and adherence to dosage are critical to minimizing adverse events.

FAQs

What is Ampyra used for?

Ampyra is used to improve walking in patients with multiple sclerosis (MS)[1].

How does Ampyra work?

Ampyra works by blocking potassium channels, though the exact mechanism of its therapeutic effect is not fully understood[1].

What were the key findings of the clinical trials for Ampyra?

The clinical trials showed that a significantly greater proportion of patients taking Ampyra had improvements in walking speed compared to those taking a placebo[1].

Why are Ampyra sales declining?

Ampyra sales are declining due to the introduction of generic versions of the drug in 2018[5].

What are the common side effects of Ampyra?

Common side effects include urinary tract infections, insomnia, dizziness, headache, nausea, and others. Seizures are a serious potential side effect, particularly in patients with kidney impairment[1][4].

Sources

1. CenterWatch, "Ampyra (dalfampridine) - CenterWatch"
2. Business Wire, "Acorda Therapeutics Provides Long-Term Business Plan and Financial Guidance"
3. Biogen, "European Medicines Agency's Committee for Medicinal Products for Human Use Issues Positive Opinion on Marketing Authorisation Application for FAMPYRA"
4. MS Canada, "Low dose Ampyra does not improve walking speed in MS"
5. MedCity News, "Biogen Bows Out of Acorda Pact on MS Med; Focus Turns to New Therapies"

Last updated: 2025-01-05