CLINICAL TRIALS PROFILE FOR LACOSAMIDE

All Clinical Trials for LACOSAMIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00220337 ↗	A Trial to Assess the Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Diabetic Neuropathy	Completed	UCB Pharma	Phase 3	2004-12-01	The purpose of this study is to determine if lacosamide (SPM 927) is safe if taken for a longer period of time and whether it continues to work well to treat pain. Subjects will receive lacosamide at a dose that will be individually determined to be the one that provides most pain relief with the least side effects. The maximum dose will be 600mg/day. Subjects may participate in this trial until October 2007. This time may be extended to allow them to participate until lacosamide is commercially available. If a subject meet the requirements for the study at Visit 1 and after a two weeks phase without trial medication, s/he enters a Titration Phase to determine the personal optimal dose of lacosamide. When this dose is reached s/he will enter the Maintenance Phase and will be asked to return for visits every 4 weeks for the first 24 weeks and every 12 weeks thereafter.
NCT00135109 ↗	Trial to Assess the Efficacy and Safety of SPM 927 (200, 400, and 600mg/Day) in Subjects With Painful Distal Diabetic Neuropathy	Completed	UCB Pharma	Phase 3	2004-10-01	This phase 3 trial is being conducted at approximately 80 sites in the United States (U.S.) to investigate whether lacosamide (SPM 927) at different doses reduces pain in subjects with diabetic neuropathy. Approximately 455 subjects will be randomized to placebo or to one of three doses of lacosamide. To qualify for this trial, subjects with symptoms of painful distal diabetic neuropathy ranging in duration from 6 months to 5 years must have an average pain intensity of greater than or equal to 4 on an 11-point Likert scale (0-10 scale) during the 7 day period prior to the start of treatment. To determine what effect lacosamide has on diabetic neuropathic pain, subjects will use a diary to record their daily pain intensity (morning and evening; and pain interference with sleep (morning) and activity (evening). Use of rescue medication (acetaminophen) and subjects' quality of life will be investigated. In addition, the safety and tolerability of the different doses of lacosamide will be investigated.
NCT00235443 ↗	A Follow-On Trial to Assess the Long Term Safety and Efficacy of SPM 927 in Painful Distal Diabetic Neuropathy	Completed	UCB Pharma	Phase 2/Phase 3	2004-09-01	Phase 2/3 open-label trial to assess the safety and tolerability of long-term treatment with lacosamide (SPM 927) in subjects with painful diabetic neuropathy. The safety and tolerability of the different doses of lacosamide will be investigated.
NCT00220415 ↗	A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Trial to Investigate the Efficacy and Safety of SPM 927 (200mg/Day and 400mg/Day) as Adjunctive Therapy in Subjects With Partial Seizures With or Without Secondary Generaliz	Completed	UCB Pharma	Phase 3	2004-05-01	Male and female patients between 16 and 70 years of age who are diagnosed with epilepsy with partial seizures and are taking up to 3 medications for this medical condition will take part in this research study at approximately 80 different locations in Australia and Europe. The purpose of this study is to evaluate the effectiveness, safety and tolerability of consistent dosages of study drug (lacosamide) taken orally twice a day for about 4 months. Each patient who qualifies and chooses to participate in the study will receive placebo (inactive drug) or gradually increasing doses of lacosamide (SPM 927) up to the target dose of 200mg/day or 400mg/day. The target dose or placebo will be maintained for 12 weeks. The study clinic visits will include a medical history and physical exam, ECG, blood and urine sample collection, and completion of a seizure diary. Patients who complete the study may enroll in an extension trial and receive active study drug.
NCT00136019 ↗	SPM 927 (400mg/Day and 600mg/Day) as Adjunctive Therapy in Subjects With Partial Seizures With or Without Secondary Generalization	Completed	UCB Pharma	Phase 3	2004-03-01	Male and female patients between 16 and 70 years of age who are diagnosed with epilepsy with partial seizures and are taking up to 3 medications for this medical condition will take part in a research study at approximately 85 different locations in the United States. The purpose of the study is to evaluate the effectiveness, safety and tolerability of consistent dosages of a study drug (lacosamide [SPM 927]) taken orally twice a day for about five months. Each patient who qualifies and chooses to participate in the study will receive placebo (inactive drug) or gradually increasing doses of lacosamide up to the target dose of 400mg/day or 600mg/day. The target dose or placebo will be maintained for 12 weeks. The study clinic visits will include a medical history and physical exam, electrocardiogram (ECG), blood and urine sample collection, and completion of a seizure diary. Patients who complete the study may enroll in an extension trial and receive active study drug.

Clinical Trial Conditions for LACOSAMIDE

Condition Name

Condition Name for LACOSAMIDE
Intervention	Trials
Epilepsy	38
Partial Epilepsies	6
Painful Diabetic Neuropathy	4
Healthy Volunteers	3

Condition MeSH

Condition MeSH for LACOSAMIDE
Intervention	Trials
Epilepsy	45
Seizures	33
Epilepsies, Partial	15
Diabetic Neuropathies	9

Clinical Trial Locations for LACOSAMIDE

Trials by Country

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Trials by Country for LACOSAMIDE
Location	Trials
United States	474
Germany	29
Australia	27
Poland	17
Canada	17

Trials by US State

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Trials by US State for LACOSAMIDE
Location	Trials
Texas	27
Ohio	23
North Carolina	22
Florida	21
Maryland	18

Clinical Trial Progress for LACOSAMIDE

Clinical Trial Phase

Clinical Trial Phase for LACOSAMIDE
Clinical Trial Phase	Trials
Phase 4	12
Phase 3	37
Phase 2/Phase 3	4

Clinical Trial Status

Clinical Trial Status for LACOSAMIDE
Clinical Trial Phase	Trials
Completed	71
Terminated	10
Recruiting	6

Clinical Trial Sponsors for LACOSAMIDE

Sponsor Name

Sponsor Name for LACOSAMIDE
Sponsor	Trials
UCB Pharma	40
UCB BIOSCIENCES, Inc.	11
UCB Japan Co. Ltd.	4

Sponsor Type

Sponsor Type for LACOSAMIDE
Sponsor	Trials
Industry	82
Other	51
NIH	3

Lacosamide: Clinical Trials, Market Analysis, and Projections

Introduction to Lacosamide

Lacosamide, an antiepileptic drug (AED), has been approved for the adjunctive treatment of partial-onset seizures in adults and children over one month old. It works by selectively enhancing the slow inactivation of voltage-gated sodium channels, making it a unique and effective treatment option for various neurological conditions.

Clinical Trials Update

LENS Study: Neonatal Seizures

One of the significant ongoing clinical trials involving lacosamide is the LENS study, which aims to evaluate the efficacy, safety, and pharmacokinetics of lacosamide in treating neonatal seizures. This multi-site clinical trial, launched in March 2021 and expected to be completed by September 2023, includes participating sites in 14 states, Australia, and Canada. The study compares lacosamide as a second-line treatment against traditionally used medications like fosphenytoin for neonatal seizures, a condition with sparse published data on the most efficacious treatments[1].

Adult and Pediatric Trials

Previous phase II/III clinical trials have provided valuable insights into the clinical utility of lacosamide in adults with partial-onset seizures. These trials, involving large patient pools, have shown that lacosamide is safe, efficacious, and cost-effective as an adjunctive therapy. Studies have also extended to include children and adults with drug-resistant focal epilepsy, highlighting its efficacy and tolerability in various patient populations[3][4].

Market Analysis

Global Market Size and Growth

The global lacosamide market is experiencing significant growth driven by the increasing incidence of neurological conditions such as epilepsy and diabetic neuropathic pain. As of 2024, the global lacosamide market size was estimated at USD 5.815 billion and is projected to grow at a compound annual growth rate (CAGR) of 4.70% from 2023 to 2030, reaching USD 7.89 billion by 2030[5].

Regional Market Breakdown

• North America: This region holds the largest market share, with over 40% of the global revenue, primarily due to the well-established healthcare system and growing awareness among medical experts. The market in North America is expected to grow at a CAGR of 3.2% from 2024 to 2031[2].
• Europe: Europe accounts for over 30% of the global market, driven by a strong healthcare infrastructure and strict regulatory requirements. The pediatric market is particularly significant here, with children with epilepsy increasingly using lacosamide[2].
• Asia Pacific: This region is experiencing rapid growth, with a CAGR of 7.0% from 2024 to 2031, due to the increasing occurrence of neurological conditions and advancements in healthcare infrastructure[2].
• Latin America and Middle East & Africa: These regions are also seeing steady growth, albeit at a slower pace, due to rising incidence of neurological conditions and efforts to improve healthcare access and infrastructure[2].

Market Drivers and Trends

Increasing Incidence of Neurological Conditions

The growing number of people with epilepsy and other neurological conditions is a major driver of the lacosamide market. According to the World Health Organization (WHO), approximately 50 million people worldwide have epilepsy, and this number is increasing, leading to a higher demand for effective treatments like lacosamide[5].

Healthcare Infrastructure and Regulatory Environment

The well-established healthcare systems in regions like North America and Europe, along with strict regulatory requirements, contribute to the market growth. The European Medicines Agency (EMA) and other regulatory bodies ensure the safety and efficacy of lacosamide, which enhances its acceptance among medical professionals[2].

Patient-Centered Care and Continuous Breakthroughs

The focus on patient-centered care and continuous advancements in treatment alternatives are propelling the market forward. Increased awareness and understanding of epilepsy and other neurological conditions are also driving the demand for lacosamide[2].

Projections and Future Outlook

Market Expansion

The lacosamide market is expected to continue its growth trajectory, driven by the expanding patient base, increasing awareness, and advancements in healthcare. The market is projected to reach USD 7.89 billion by 2030, with significant contributions from North America, Europe, and the Asia Pacific regions[5].

Research and Development

Ongoing and future clinical trials, such as the LENS study, will play a crucial role in expanding the use of lacosamide into new patient populations, including neonates. These studies will provide further evidence of its efficacy and safety, potentially leading to broader approval and increased market share[1].

Observational Studies and Real-World Data

Observational studies and real-world data analyses will continue to provide valuable insights into the long-term efficacy, safety, and tolerability of lacosamide in routine clinical practice. These studies will help in understanding treatment patterns, adoption rates, and adverse effects in diverse patient populations[4].

Key Takeaways

• Clinical Trials: Ongoing trials like the LENS study are evaluating lacosamide's efficacy in neonatal seizures and other conditions.
• Market Growth: The global lacosamide market is projected to grow significantly, driven by increasing incidence of neurological conditions and advancements in healthcare.
• Regional Performance: North America, Europe, and the Asia Pacific are key regions driving market growth.
• Market Drivers: Increasing awareness, well-established healthcare systems, and regulatory environments are major drivers.
• Future Outlook: The market is expected to expand, with ongoing research and development playing a crucial role.

FAQs

What is the primary use of lacosamide?

Lacosamide is primarily used as an adjunctive treatment for partial-onset seizures in adults and children over one month old.

What is the LENS study?

The LENS study is a clinical trial evaluating the efficacy, safety, and pharmacokinetics of lacosamide in treating neonatal seizures.

How is the global lacosamide market expected to grow?

The global lacosamide market is projected to grow at a CAGR of 4.70% from 2023 to 2030, reaching USD 7.89 billion by 2030.

Which regions are driving the growth of the lacosamide market?

North America, Europe, and the Asia Pacific are the key regions driving the growth of the lacosamide market.

What are the main drivers of the lacosamide market?

The main drivers include the increasing incidence of neurological conditions, well-established healthcare systems, and continuous advancements in treatment alternatives.

How does lacosamide work?

Lacosamide works by selectively enhancing the slow inactivation of voltage-gated sodium channels, making it an effective treatment for partial-onset seizures.

Sources

1. CHOC patient enrolled in clinical trial for anti-seizure medications - CHOC Children's.
2. Lacosamide Market will grow at a CAGR of 5.00% from 2024 to 2031 - Cognitive Market Research.
3. Examining the clinical utility of lacosamide: pooled analyses of three ... - PubMed.
4. Clinical Efficacy and Safety of Lacosamide as an Adjunctive ... - Frontiers in Neurology.
5. Lacosamide Market Size, Share, Trends, Growth & Forecast - Verified Market Research.