Lacosamide for Epilepsy

(VALUE Trial)

No longer recruiting at 147 trial locations

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: UCB BIOSCIENCES, Inc.

Must be taking: Lacosamide

Must not be taking: Investigational drugs

Disqualifiers: Suicidal ideation, Liver dysfunction, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All 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 Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: up to approximately 5 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the safety and effectiveness of lacosamide (also known as Vimpat, Motpoly XR, Lacolit, erlosamide, harkoseride, SPM-927, or ADD 234037) when added to other treatments for individuals with ongoing tonic-clonic seizures. These seizures, a type of epilepsy, cause muscle stiffness and jerking. The trial focuses on individuals with idiopathic generalized epilepsy, where the cause is unknown. Those who completed a previous study or were eligible but couldn't participate may be suitable if they still experience uncontrolled seizures despite treatment. Participants should not use other experimental drugs or devices. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

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.

Is there any evidence suggesting that lacosamide is likely to be safe for humans?

Research shows that lacosamide is generally well-tolerated in adults and children weighing at least 50 kg (about 110 pounds). Studies have found that dizziness, sleepiness, headaches, and nausea are the most common side effects, affecting more than 10% of those using the treatment.

The FDA has already approved lacosamide for treating a different type of seizure, indicating it is somewhat safe for humans. However, its safety for children under 50 kg remains less understood. Since this study is in a later phase, earlier tests have demonstrated the treatment's relative safety.

Prospective participants should consider these findings and discuss any concerns with their healthcare provider. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Lacosamide is unique because it offers a different mechanism of action compared to traditional treatments for epileptic tonic-clonic seizures, such as valproate, levetiracetam, or phenytoin. Most existing drugs target sodium channels in a general manner, but lacosamide targets these channels in a novel way by enhancing slow inactivation. This specific action could potentially lead to fewer side effects and better seizure control. Researchers are excited because this targeted approach might provide an effective option for patients who have not found relief with other medications.

What evidence suggests that lacosamide is effective for uncontrolled primary generalized tonic-clonic seizures?

Research has shown that lacosamide can reduce seizures in adults and children with epilepsy. Previous studies found it particularly effective for individuals with drug-resistant partial-onset seizures, which are difficult to treat. In this trial, participants will receive lacosamide to evaluate its effectiveness for tonic-clonic seizures in patients with idiopathic generalized epilepsy. The earlier success with other seizure types is encouraging. Lacosamide stabilizes electrical activity in the brain, helping to control seizures. Evidence supports its use as an additional treatment, demonstrating it can significantly benefit those who haven't succeeded with other treatments. ^{5 6 7 8 9}

Who Is on the Research Team?

UCB Cares

Principal Investigator

001 844 599 2273

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Lacosamide

How Is the Trial Designed?

Group I: Lacosamide Experimental Treatment 2 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

Who Is Running the Clinical Trial?

UCB BIOSCIENCES, Inc.

Lead Sponsor

Trials

28

Recruited

7,200+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The nociceptin receptor as a potential target in drug design. Smith, PA., Moran, TD.[2003]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lacosamide: A Review in Focal Seizures in Patients with Epilepsy. Scott, LJ.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lacosamide. Perucca, E., Yasothan, U., Clincke, G., et al.[2018]

Citations

1. fda.gov fda.gov/media/170701/download

Clinical Review: Motpoly XR (Lacosamide) Vimpat has been found to be effective in reducing seizure frequency in adult and pediatric patients as young as one month of age with. POS.

2. motpolyxrhcp.com motpolyxrhcp.com/efficacy

Efficacy | MOTPOLY XR™ Lacosamide demonstrated significant control of partial-onset seizures with or without secondary generalization. Efficacy demonstrated in pooled analysis ...

3. neurology.org neurology.org/doi/10.1212/WNL.0000000000211118

The Safety and Efficacy of Adjunctive Lacosamide for ... Adjunctive Lacosamide significantly enhances the efficacy of treatment for patients with drug-resistant partial-onset seizures, but clinicians ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7509528/

Efficacy and safety of adjunctive lacosamide in the ... Overall, 28.1% of patients in the lacosamide group and 34.7% in the placebo group were reported to have juvenile myoclonic epilepsy and 10.7% ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0920121124000652

Lacosamide extended-release capsules are bioequivalent ... The primary outcome was to determine bioequivalence of lacosamide XR capsules to lacosamide IR tablets, as measured by the 90% confidence interval for ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2023/216185s000lbl.pdf

Motpoly™ XR - accessdata.fda.gov The safety and effectiveness of MOTPOLY XR for the treatment of partial-onset seizures have been established in pediatric patients weighing at least 50 kg. Use ...

7. motpolyxrhcp.com motpolyxrhcp.com/safety

Safety | MOTPOLY XR™ Most common adverse reactions (≥10%) reported in patients treated with lacosamide were dizziness (23%), somnolence (17%), headache (14%), and nausea (10%), ...

8. mayoclinic.org mayoclinic.org/drugs-supplements/lacosamide-oral-route/description/drg-20072409

Lacosamide (oral route) - Side effects & dosage Safety and efficacy have not been established. Appropriate studies have not been performed on the relationship of age to the effects of Vimpat® ...

9. motpolyxr.com motpolyxr.com/

MOTPOLY XR™ It is not known if MOTPOLY XR is safe and effective for partial-onset seizures in children weighing less than 50 kg. IMPORTANT SAFETY INFORMATION. Do not ...