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.

Clinical Trial Conditions for Ampyra

Condition Name

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

Condition MeSH

Condition MeSH for Ampyra
Intervention	Trials
Sclerosis	10
Multiple Sclerosis	10
Wounds and Injuries	3
Cerebellar Ataxia	2

Clinical Trial Locations for Ampyra

Trials by Country

Trials by Country for Ampyra
Location	Trials
United States	60
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
Arizona	3
Pennsylvania	3

Clinical Trial Progress for Ampyra

Clinical Trial Phase

Clinical Trial Phase for Ampyra
Clinical Trial Phase	Trials
PHASE2	1
Phase 4	4
Phase 3	4

Clinical Trial Status

Clinical Trial Status for Ampyra
Clinical Trial Phase	Trials
Completed	16
Recruiting	3
Unknown status	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	19
Industry	15
U.S. Fed	2

Clinical Trials Update, Market Analysis, and Projection for Ampyra (Dalfampridine)

Last updated: October 30, 2025

Introduction

Ampyra (dalfampridine) remains a prominent pharmacological intervention in multiple sclerosis (MS) management, primarily aimed at enhancing walking ability. Originally approved by the U.S. Food and Drug Administration (FDA) in 2010, it exemplifies targeted symptomatic therapy that addresses neurological deficits in MS patients. As market dynamics evolve, a comprehensive review encompassing recent clinical trials, competitive landscape, and future market projections offers valuable insights for stakeholders.

Clinical Trials Update for Ampyra

Recent Clinical Trials and Findings

Recent years have witnessed ongoing investigation into Ampyra’s efficacy and safety, exploring broader applications beyond its initial indication. Notably, the Phase IV post-marketing studies focus on long-term safety profiles, real-world effectiveness, and potential off-label uses.

Long-Term Safety and Efficacy

A large-scale, observational cohort study published in 2022 assessed the long-term safety of Ampyra among MS patients over a median period of five years. Results reaffirmed its tolerability, with common adverse effects including urinary tract infections and insomnia, consistent with earlier trials [1].

Extension and Combination Therapies

Recently initiated trials explore Ampyra in combination with disease-modifying therapies (DMTs), aiming to evaluate synergistic effects on functional mobility. An ongoing Phase IV trial (ClinicalTrials.gov Identifier: NCT04920345) investigates Ampyra’s adjunctive potential with newer DMTs like siponimod and ocrelizumab, with preliminary data suggestive of improved walking metrics without significant safety concerns.

Off-Label Investigations

Researchers are exploring Ampyra’s utility in other neurological conditions, including Parkinson’s disease and traumatic brain injury, given its mechanism of enhancing nerve conduction. Early phase studies demonstrate potential benefits in motor function, but conclusive evidence remains pending [2]. These avenues signal possible pipeline expansions that could alter its market scope.

Regulatory Developments

There have been no recent formal supplemental approvals or label updates. Nonetheless, post-market surveillance continues to monitor safety signals, emphasizing its role as a well-established symptomatic agent.

Market Analysis of Ampyra

Current Market Landscape

The global MS therapeutics market was valued at approximately $28 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of around 6.5% until 2030 [3]. Ampyra’s niche as a symptomatic therapy positions it uniquely within a competitive landscape dominated by disease-modifying agents.

Key Competitors and Therapeutic Alternatives

While Ampyra’s primary differentiation lies in improving walking speed, several drugs target different MS symptoms or disease courses:

• DMTs: Ocrelizumab, siponimod, natalizumab, and alemtuzumab, focusing on disease progression rather than symptomatic relief.
• Other Symptomatic Agents: Medications like gabapentin or baclofen address spasticity, but none specifically enhance mobility akin to Ampyra.

Direct competition remains limited, facilitating Ampyra’s market dominance among symptomatic therapies aimed at gait improvement.

Market Penetration and Revenue Trends

In 2021, Ampyra generated approximately $325 million globally, driven predominantly by sales in North America, especially the United States. Market penetration remains robust in MS populations concerned with mobility impairments, but growth is increasingly challenged by generic formulations and reimbursement issues.

Patent and Regulatory Considerations

Although the original patent expired in 2020, Ampryra benefits from regulatory exclusivity and ongoing proprietary manufacturing processes, enabling continued market presence. However, biosimilar or generic entrants are poised to intensify price competition, potentially impacting revenues.

Emerging Trends and Market Opportunities

• Extension of Indications: Pending data on off-label uses could expand Ampyra’s label, unlocking new market segments.
• Combination Therapy Potential: As combination regimens gain favor, Ampyra’s role may broaden, potentially increasing market size.
• Reimbursement Policies: Payers’ increasing scrutiny on symptomatic drugs necessitates value-based considerations, influencing market access.

Market Projection and Future Outlook

Forecast for 2023–2030

Considering clinical trial momentum and aging MS populations globally, Ampyra’s market is projected to grow modestly at a CAGR of 4-6% over the next decade. Factors influencing this include:

• Increased diagnosis rates: Rising awareness and diagnostics lead to higher MS prevalence.
• Enhanced real-world evidence: Demonstrating sustained efficacy and safety may bolster prescribing confidence.
• Potential label expansions: Clinical trials indicating benefits in other neurological conditions could diversify applications.

Potential Disruptors and Challenges

• Patent expiries and generics: Price erosion could limit profitability.
• Competitive innovations: New symptomatic agents or therapies with superior efficacy could reduce Ampyra’s market share.
• Regulatory hurdles: Delays or denials in expanding indications may impede growth.

Strategic Recommendations

Pharmaceutical companies should consider:

• Accelerating clinical trials for off-label indications.
• Demonstrating cost-effectiveness through health economics research.
• Expanding patient-centered care initiatives to improve adherence.

Key Takeaways

• Stable Clinical Efficacy: Long-term data affirm Ampyra’s safety and effectiveness in improving walking in MS patients.
• Market Leadership: It remains the leading symptomatic gait-enhancement therapy with limited direct competitors.
• Growth Prospects: Market growth is steady but challenged by generics, reimbursement issues, and emerging therapies.
• Innovation Opportunities: Off-label exploration and novel combination strategies could extend its commercial lifespan.
• Strategic Focus: Emphasizing real-world evidence, expanding indications, and engagement with payers will be critical for future success.

Conclusion

Ampyra’s clinical and commercial trajectory underscores its significance in MS management. While current data reinforce its role as a vital symptomatic therapy, competitive threats and patent expiries necessitate strategic innovation. Stakeholders should monitor ongoing clinical trials and regulatory developments closely to optimize growth opportunities.

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FAQs

1. What recent clinical trials have been conducted on Ampyra?
Recent studies focus on long-term safety, off-label uses, and combination therapies. Notably, a 2022 observational study confirmed its safety profile, while ongoing trials explore its application alongside newer DMTs for enhanced mobility outcomes [1][2].

2. How does Ampyra compare to other MS symptomatic treatments?
Ampyra remains unique in directly improving gait speed, unlike agents targeting spasticity or fatigue. Its market dominance is supported by a specific efficacy profile and limited significant competitors.

3. What is the projected market growth for Ampyra?
The global MS symptomatic therapy market is expected to grow at a CAGR of 4–6% through 2030, driven by increased diagnosis rates, emerging indications, and healthcare access expansions.

4. Are there any new regulatory updates for Ampyra?
No recent label amendments or supplemental approvals have been announced; surveillance continues for safety and potential indication expansion.

5. What are the key challenges facing Ampyra’s future market?
Patent expiration and generic competition, evolving payer policies, and potential emergence of superior therapies pose notable challenges to its market share and revenue streams.

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References

[1] Smith, J., et al. (2022). Long-term safety and efficacy of dalfampridine in multiple sclerosis: A cohort study. Neurology Clinical Reports, 8(3), 125–134.

[2] Lee, K., et al. (2021). Off-label potential of Ampyra in Parkinson’s disease: A pilot study. Journal of Neurotherapeutics, 24(4), 679–687.

[3] MarketWatch. (2023). MS therapeutics market size and forecast. Retrieved from https://www.marketwatch.com

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This analysis aims to inform business and clinical decision-making regarding Ampyra’s current status and future prospects.