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Lacosamide Oral Solution for Epilepsy (VALUE Trial)

Phase 3
Waitlist Available
Research Sponsored by UCB BIOSCIENCES, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from visit 1 (week 0) to end of treatment period (up to approximately 5 years), compared to the prospective sp0982 baseline period
Awards & highlights

VALUE Trial Summary

This trial is testing the long-term safety and effectiveness of lacosamide as a treatment for uncontrolled primary generalized tonic-clonic seizures in people with idiopathic generalized epilepsy.

Eligible Conditions
  • Epilepsy

VALUE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from visit 1 (week 0) to end of treatment period (up to approximately 5 years), compared to the prospective sp0982 baseline period
This trial's timeline: 3 weeks for screening, Varies for treatment, and from visit 1 (week 0) to end of treatment period (up to approximately 5 years), compared to the prospective sp0982 baseline period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Study Participants With New Appearance of Absence and/or Myoclonic Seizures During the Treatment Period
Number of Study Participants With Treatment-emergent Adverse Events (TEAEs) Over the Duration of the Treatment Period
Number of Study Participants With an Increase of >25% to 50% in Days With Myoclonic Seizures Per 28 Days During the Treatment Period as Compared to the Prospective Baseline (of Study SP0982)
+10 more
Secondary outcome measures
Percent Change in Primary Generalized Tonic-clonic Seizure (PGTCS) Frequency Per 28 Days From Combined Baseline
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (Heart Rate Interval)
Percentage of Study Participants With Treatment-emergent Marked Abnormalities (TEMAs) in 12-lead ECG Parameter (PR Interval)
+33 more

VALUE Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lacosamide Oral Solution
2015
Completed Phase 3
~240
Lacosamide Tablet
2015
Completed Phase 3
~490

Find a Location

Who is running the clinical trial?

UCB BIOSCIENCES, Inc.Lead Sponsor
25 Previous Clinical Trials
6,961 Total Patients Enrolled
13 Trials studying Epilepsy
3,317 Patients Enrolled for Epilepsy
UCB CaresStudy Director001 844 599 2273
203 Previous Clinical Trials
44,123 Total Patients Enrolled
48 Trials studying Epilepsy
11,584 Patients Enrolled for Epilepsy

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA cleared Lacosamide Oral Solution for public use?

"Based on our internal criteria, we believe that the safety of this medication to be a 3."

Answered by AI

Are there any more subjects needed to complete this research project?

"The clinical trial mentioned is not presently looking for patients as per the information available on clinicaltrials.gov. The said trial was initially posted on 8/3/2015 and was most recently edited on 9/22/2022. Although this study is not enrolling candidates anymore, there are 288 other trials presently enrolling patients right now."

Answered by AI

What other similar tests have been conducted in the past?

"As of now, 4 different clinical trials for Lacosamide Oral Solution are ongoing in 35 cities and 25 countries. The first ever study was conducted in 2015 and, since then, 66 others have been completed. That initial trial, sponsored by UCB BIOSCIENCES, Inc., had 239 participants and reached Phase 3 approval."

Answered by AI

In how many distinct geographical areas is this research being conducted?

"This study is taking place at 32 locations, some of which include Ep0012 042 in Loxahatchee Groves, Ep0012 013 in Panama City, and Ep0012 031 in Colorado Springs."

Answered by AI

Are there any other ongoing or completed studies involving Lacosamide Oral Solution?

"The medication known as Lacosamide Oral Solution was first researched in 2015 under the study Ep0012 914. To date, 66 studies have completed. There are currently 4 ongoing clinical trials, a few of which are based in Loxahatchee Groves, Florida."

Answered by AI

How many research subjects are included in these findings?

"This study is not presently seeking candidates at this time. The clinical trial was first posted on 8/3/2015 and was last edited on 9/22/2022. If you are seeking for other studies, there are presently 284 trials actively looking for participants with aura and 4 studies for Lacosamide Oral Solution actively looking for participants."

Answered by AI
~25 spots leftby Mar 2025