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Last Updated: April 20, 2025

CLINICAL TRIALS PROFILE FOR VIMPAT


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All Clinical Trials for Vimpat

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00237458 ↗ An Open-label Continuation Trial to Assess the Continued Efficacy and Safety of Ascending Doses of Lacosamide in Subjects With Chronic Refractory Neuropathic Pain Completed UCB Pharma Phase 2 2001-05-01 This trial is the follow-on trial to a preceeding open-label trial which included patients with chronic refractory neuropathic pain. It is conducted at one site in the United Kingdom and the patient enrollment is completed. The patients had successfully completed the above mentioned trial and, in the investigator's opinion, would benefit from long-term administration of Lacosamide. After a 1-week run-in phase the patients were uptitrated to their optimal dose and then continued into the maintenance phase. Different pain qualities are assessed by a patient's diary.
NCT00401830 ↗ Assessing Efficacy and Safety of Lacosamide Compared to Placebo in Reducing Signs and Symptoms of Fibromyalgia Syndrome. Completed UCB Pharma Phase 2 2006-10-01 This trial investigated the efficacy and safety of 400mg/day of lacosamide as compared to placebo in reducing the signs and symptoms of fibromyalgia syndrome.
NCT00440518 ↗ A Study Designed to Test the Effectiveness and Safety of Treating Patients With Lacosamide for Migraine Prophylaxis Completed UCB Pharma Phase 2 2007-02-01 The purpose of this study is to see how safe and effective Lacosamide (LCM) is when taken by mouth, twice a day for up to 18 weeks to prevent migraines.
NCT00485472 ↗ Trial to Assess Efficacy and Safety of Lacosamide in Subjects With Osteoarthritis of the Knee Terminated UCB Pharma Phase 2 2007-03-01 The purpose of this trial is to evaluate the effectiveness, safety and tolerability of lacosamide (LCM) 400mg/day in treating the signs and symptoms of osteoarthritis of the knee.
NCT00520741 ↗ Trial to Demonstrate the Efficacy and Safety of Conversion to Lacosamide Monotherapy for Partial-onset Seizures Completed UCB BIOSCIENCES, Inc. Phase 3 2007-08-01 The objective of this historical-controlled trial is to demonstrate the efficacy and safety of conversion to Lacosamide monotherapy in subjects with Partial-onset Seizures who are withdrawn from 1 to 2 marketed antiepileptic drugs.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Vimpat

Condition Name

Condition Name for Vimpat
Intervention Trials
Epilepsy 22
Partial Epilepsies 4
Partial Onset Seizures 3
Partial-onset Seizures 3
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Condition MeSH

Condition MeSH for Vimpat
Intervention Trials
Epilepsy 29
Seizures 25
Epilepsies, Partial 10
Glioma 2
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Clinical Trial Locations for Vimpat

Trials by Country

Trials by Country for Vimpat
Location Trials
United States 302
Germany 17
Australia 14
Poland 12
Canada 12
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Trials by US State

Trials by US State for Vimpat
Location Trials
Texas 17
Ohio 17
Florida 14
North Carolina 13
California 12
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Clinical Trial Progress for Vimpat

Clinical Trial Phase

Clinical Trial Phase for Vimpat
Clinical Trial Phase Trials
Phase 4 5
Phase 3 20
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Vimpat
Clinical Trial Phase Trials
Completed 39
Terminated 7
Not yet recruiting 2
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Clinical Trial Sponsors for Vimpat

Sponsor Name

Sponsor Name for Vimpat
Sponsor Trials
UCB Pharma 21
UCB BIOSCIENCES, Inc. 8
UCB Japan Co. Ltd. 4
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Sponsor Type

Sponsor Type for Vimpat
Sponsor Trials
Industry 49
Other 20
NIH 3
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VIMPAT (Lacosamide): Clinical Trials, Market Analysis, and Projections

Introduction to VIMPAT

VIMPAT, known generically as lacosamide, is a significant player in the epilepsy treatment market. Developed by UCB, it is distributed and marketed in collaboration with Daiichi Sankyo in Japan. Here, we delve into the clinical trials, market analysis, and future projections for this drug.

Mechanism of Action

VIMPAT works by selectively promoting the gradual inactivation of potential-dependent Na channels, thereby suppressing excessive neuronal excitation. This unique mechanism sets it apart from other antiepileptic drugs (AEDs), although the precise mechanism of its antiepileptic effect in humans is still not fully understood[3].

Clinical Trials and Efficacy

Long-Term Efficacy

Clinical trials have demonstrated that VIMPAT provides sustained efficacy for up to five years when used as an adjunctive treatment for partial-onset seizures. Pooled data from double-blind and open-label trials involving 1,327 patients showed consistent reduction in seizure frequency over the treatment period[3].

Real-World Data

Real-world data from a retrospective chart review published in Acta Neurologica Scandinavica confirmed that outcomes with lacosamide monotherapy for focal seizures are similar to those in clinical trials. The study noted that patients who received lacosamide as first-line monotherapy had a higher seizure-free status compared to those who were converted to lacosamide after other AEDs. Adverse events, particularly dizziness, were found to be relatively low, possibly due to more responsive dosing adjustments in real-world practice[4].

Expanded Indications

In Japan, a supplemental application was filed to expand the indication for VIMPAT to include adjunctive therapy for tonic-clonic seizures in epilepsy patients. This move aims to broaden the therapeutic scope of the drug, further solidifying its position in the epilepsy treatment market[1].

Market Analysis

Global Market Forecast

The global epilepsy drugs market, which includes VIMPAT, is projected to cross the $9 billion mark by 2025. VIMPAT, along with Keppra (levetiracetam) and Epidiolex, plays a significant role in this market. The United States dominates this market due to its robust healthcare system, growing awareness, and increasing per capita healthcare expenditure[5].

Market Segmentation

The epilepsy drugs market is categorized into three generations: first, second, and third. VIMPAT falls under the second and third generation of AEDs, which are anticipated to play a crucial role in the market during the forecast period of 2019-2025. These newer generations offer improved efficacy and safety profiles compared to older drugs[2][5].

Competitive Landscape

VIMPAT competes with other notable AEDs such as Keppra, Sabril (vigabatrin), Onfi (clobazam), Fycompa, Briviact (brivaracetam), and Epidiolex. Despite the competition, VIMPAT's unique mechanism of action and sustained efficacy make it a preferred choice for many clinicians and patients[2][5].

Market Projections

Growth Drivers

The growth of the epilepsy drugs market, including VIMPAT, is driven by several factors:

  • Increasing Prevalence of Epilepsy: The rising number of epilepsy cases globally contributes to the demand for effective treatments.
  • Advancements in Drug Development: The introduction of second and third-generation AEDs like VIMPAT has improved treatment outcomes.
  • Better Healthcare Infrastructure: Countries with advanced healthcare systems, such as the United States, are expected to drive market growth[5].

Regional Performance

The United States is expected to maintain its dominance in the global epilepsy drugs market. Other significant markets include the UK, France, Germany, Italy, Spain, India, China, and Japan. The collaboration between UCB and Daiichi Sankyo in Japan has been instrumental in expanding VIMPAT's reach in this region[5].

Safety and Adverse Events

Clinical trials and real-world data have shown that VIMPAT has a favorable safety profile. The most common adverse drug reaction is dizziness, but this occurs at a lower frequency in real-world practice compared to clinical trials, possibly due to more individualized dosing adjustments[4].

Conclusion

VIMPAT (lacosamide) is a crucial drug in the treatment of epilepsy, particularly for partial-onset and focal seizures. Its sustained efficacy, unique mechanism of action, and favorable safety profile make it a significant player in the global epilepsy drugs market. As the market continues to grow, driven by increasing prevalence and advancements in drug development, VIMPAT is poised to remain a key treatment option.

Key Takeaways

  • Sustained Efficacy: VIMPAT provides consistent reduction in seizure frequency for up to five years.
  • Unique Mechanism: It works by selectively promoting the gradual inactivation of potential-dependent Na channels.
  • Market Dominance: The drug plays a significant role in the global epilepsy drugs market, expected to cross $9 billion by 2025.
  • Safety Profile: VIMPAT has a favorable safety profile with low incidence of adverse events like dizziness.
  • Expanded Indications: Efforts are underway to expand its indication for tonic-clonic seizures.

FAQs

What is the mechanism of action of VIMPAT?

VIMPAT works by selectively promoting the gradual inactivation of potential-dependent Na channels, thereby suppressing excessive neuronal excitation.

How long does VIMPAT maintain its efficacy?

Clinical trials have shown that VIMPAT maintains its efficacy for up to five years when used as an adjunctive treatment for partial-onset seizures.

What are the common adverse events associated with VIMPAT?

The most common adverse drug reaction is dizziness, although it occurs at a lower frequency in real-world practice compared to clinical trials.

Which regions dominate the market for VIMPAT?

The United States dominates the global epilepsy drugs market, followed by other significant markets such as the UK, France, Germany, Italy, Spain, India, China, and Japan.

What is the projected market size for epilepsy drugs by 2025?

The global epilepsy drugs market, including VIMPAT, is projected to cross the $9 billion mark by 2025.

Sources

  1. UCB Japan Co., Ltd. and Daiichi Sankyo Company, Limited. "Anti-epilepsy Drug VIMPATĀ®, Submission for Supplemental Application to Expand Indication for Adjunctive Therapy for Tonic-Clonic Seizures in Epilepsy Patients." February 27, 2020.
  2. Business Wire. "The 2019 Global Epilepsy Drugs Market - $9+ Billion Forecast to 2025: Vimpat, Keppra and Epidiolex are Playing a Significant Role - ResearchAndMarkets.com." February 4, 2019.
  3. PR Newswire. "New Data for VimpatĀ® (Lacosamide) C-V Showed Sustained Efficacy for Up to 5 Years and Improved Seizure Control When Added to a Broad Range of Antiepileptic Drugs."
  4. HCPLive. "Real-World Data of Lacosamide for Focal Seizures Confirms Clinical Trial Outcomes." November 29, 2018.
  5. GlobeNewswire. "Global Epilepsy Drugs Market 2013-2019 & 2025 by Drugs (Vimpat, Keppra, Sabril, Onfi, etc), Treatment Drugs Generation (First, Second, Third), Companies & Forecasts." February 19, 2019.

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