239 Participants Needed

Safety and Efficacy of Lacosamide as Additional Therapy in Patients Suffering From Epileptic Tonic-Clonic Seizures

(VALUE Trial)

Recruiting at 118 trial locations
Age: Any Age
Sex: Any
Trial Phase: Phase 3
Sponsor: UCB BIOSCIENCES, Inc.
Must be taking: Lacosamide
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

This trial tests the safety and effectiveness of an oral medication called lacosamide for patients aged 4 and older who have epilepsy with uncontrolled seizures. Lacosamide helps stabilize brain activity to reduce seizures.

Do I need to stop my current medications for this trial?

The trial does not specify if you need to stop your current medications, but you cannot be on any investigational drugs or using experimental devices besides lacosamide.

What data supports the effectiveness of the drug Lacosamide?

Lacosamide is effective in controlling seizures in patients with epilepsy, as shown in clinical trials where it significantly reduced seizure rates when used alongside other antiepileptic drugs. It is generally well tolerated and can be used as both oral and intravenous therapy, providing flexibility in treatment options.12345

How does this drug differ from other treatments for pain?

This drug is unique because it combines properties of both μ- and δ-opioid receptor agonists, offering potent pain relief similar to gabapentin and sufentanil, but with a novel structure that may provide different effects or benefits compared to traditional opioids.678910

Research Team

UC

UCB Cares

Principal Investigator

001 844 599 2273

Eligibility Criteria

Inclusion Criteria

- Subject must have completed or be an eligible Baseline failure from the parent study (SP0982 [NCT02408523]). Note: Other subjects screened for SP0982 may be considered for roll-over to EP0012 if the investigator considers that the subject could benefit from treatment with open-label lacosamide (LCM) and based on prior discussion with and approval from the UCB Study Physician or representative

Exclusion Criteria

You are currently taking any experimental medication or using any experimental medical devices, other than lacosamide (LCM).
You have experienced severe side effects or cannot continue with a previous treatment.
You have recently had thoughts of hurting or killing yourself, as indicated by a specific questionnaire.
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral lacosamide as adjunctive therapy for uncontrolled primary generalized tonic-clonic seizures

up to approximately 5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Participants may continue to receive lacosamide to evaluate long-term safety and efficacy

Long-term

Treatment Details

Interventions

  • Lacosamide
Participant Groups
1Treatment groups
Experimental Treatment
Group I: LacosamideExperimental Treatment2 Interventions
Start dose SP0982 completers at V1: * LCM 10 mg/kg/day for pediatric subjects weighing \<30 kg * LCM 8 mg/kg/day for pediatric subjects weighing ≥ 30kg to \<50 kg * LCM 400 mg/day (200 mg bid) for adult subjects (≥18 years of age) or pediatric subjects weighing ≥50 kg SP0982 Baseline failures at V1: * LCM 2 mg/kg/day for pediatric subjects weighing \<50 kg * LCM 100 mg/day (50 mg bid) for adult subjects (≥18 years of age) or pediatric subjects weighing ≥50 kg Oral solution (pediatric subjects \<50 kg): * Minimum LCM dose: 4 mg/kg/day * Maximum LCM dose: 12 mg/kg/day Tablets (pediatric subjects ≥50kg): * Minimum LCM dose: 200 mg/day * Minimum LCM dose: 600 mg/day Tablets (adult subjects): * Minimum LCM dose: 200 mg/day * Maximum LCM dose: 800 mg/day

Find a Clinic Near You

Who Is Running the Clinical Trial?

UCB BIOSCIENCES, Inc.

Lead Sponsor

Trials
28
Recruited
7,200+

Findings from Research

Lacosamide (Vimpat) was approved in August 2008 by the European Commission and in October 2008 by the FDA as an adjunctive therapy for partial-onset seizures in epilepsy patients.
The approval indicates that lacosamide is considered a safe and effective option to help manage seizures when used alongside other treatments.
Lacosamide.Perucca, E., Yasothan, U., Clincke, G., et al.[2018]
Lacosamide is effective as both monotherapy (in the USA) and adjunctive therapy for focal seizures in adults and adolescents, showing significant reductions in seizure rates compared to placebo in clinical trials.
Patients can safely switch from oral to intravenous lacosamide therapy at the same dosage, making it a flexible treatment option, especially when oral administration is not feasible.
Lacosamide: A Review in Focal Seizures in Patients with Epilepsy.Scott, LJ.[2018]
The nociceptin/orphanin FQ system, involving the new OP(4) receptor, shows potential for drug development, as OP(4) agonists could help manage various conditions like neuropathic pain, anxiety, and drug dependence, while OP(4) antagonists may serve as general analgesics.
Unlike traditional opioids, nociceptin can produce spinal analgesia but may also counteract the effects of conventional opioids, highlighting the need for careful consideration of its unique effects in pain management.
The nociceptin receptor as a potential target in drug design.Smith, PA., Moran, TD.[2003]

References

Lacosamide: a Study of Exposures Reported to US Poison Centers over a 9-Year Period. [2020]
Drug binding assays do not reveal specific binding of lacosamide to collapsin response mediator protein 2 (CRMP-2). [2021]
Lacosamide. [2018]
Lacosamide: A Review in Focal Seizures in Patients with Epilepsy. [2018]
A simple HPLC-UV method for the determination of lacosamide in human plasma. [2018]
Superpotent [Dmt¹] dermorphin tetrapeptides containing the 4-aminotetrahydro-2-benzazepin-3-one scaffold with mixed μ/δ opioid receptor agonistic properties. [2019]
Structure-activity relationship of dermorphin on gastric secretion. [2018]
Functional expression, activation and desensitization of opioid receptor-like receptor ORL1 in neuroblastoma x glioma NG108-15 hybrid cells. [2023]
The nociceptin receptor as a potential target in drug design. [2003]
10.United Statespubmed.ncbi.nlm.nih.gov
Synthesis and opioid activity of dermorphin tetrapeptides bearing D-methionine S-oxide at position 2. [2019]
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