AN EXPLORATIVE STUDY TO EVALUATE THE TOLERABILITY AND EFFICACY OF LACOSAMIDE WHENADDED TO LEVETIRACETAM WITH WITHDRAWAL OF THE CONCOMITANT SODIUM CHANNEL BLOCKING ANTIEPILEPTIC DRUG IN SUBJECTS WITH UNCONTROLLED PARTIAL-ONSET SEIZURES

• Conditions: Epilepsy with partial onset seizures; MedDRA version: 14.1Level: PTClassification code 10015037Term: EpilepsySystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2011-002461-37-AT
• Lead Sponsor: CB BIOSCIENCES Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-01
• Last Update Posted: 17 February 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Subject is male or female, at least 18 years of age.
2. Subject has a diagnosis of epilepsy with partial-onset seizures according to the International Classification of Epileptic Seizures (1981).
3. Subject is taking LEV in combination with 1 sodium channel blocking antiepileptic drug (defined as carbamazepine, lamotrigine, oxcarbazepine, phenytoin, or eslicarbazepine) as adjunctive treatment for epilepsy.
4. The minimum required seizure frequency during the 8-week Retrospective Seizure Baseline is on average =2 partial-onset seizures per 28 days with at least 1 seizure per 4 week period within the 8-week Retrospective Seizure Baseline. Additionally, subjects must experience at least 1 seizure during the 4-week Prospective Seizure Baseline.
5. Subject has been maintained on a stable dose of LEV and a sodium channel blocking antiepileptic drug for at least 4 weeks prior to the Screening Visit (Visit 1) and during the 4-week Prospective Seizure Baseline.
6. The minimum required seizure frequency during the 8-week Retrospective Seizure Baseline is on average =2 partial-onset seizures (IA, IB, or IC) per 28 days (based on investigator assessment of subject report) with at least 1 seizure per 4 week period within the 8-week Retrospective Seizure Baseline.
7. Subject has been maintained on a stable dose of LEV and a SCB-AED for at least 4 weeks prior to the Screening Visit (Visit 1) and during the 4-week Prospective Seizure Baseline, with or without additional concurrent stable vagal nerve stimulation (VNS). The VNS must have been in place for at least 6 months prior to the Screening Visit (Visit 1) with constant settings for at least 4-weeks prior to the Screening Visit (Visit 1) and throughout the duration of the study.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 294
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

1. Previous use of lacosamide.
2. History of alcohol or drug abuse.
3. History of seizure disorder characterized primarily by isolated auras.
4. History of primary generalized seizures.
5. History of status epilepticus within the 12-months.
6. History of clustering seizures.
7. Nonepileptic events, including pseudoseizures that could be confused with seizures
8. History of any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize the subject’s health or would compromise the subject’s ability to participate in this study.
9. Lifetime history of suicide attempt,or suicidal ideation in the past 6 months.
10. Hypersensitivity to any component of LCM.
11. History of acute or sub-acute progressive central nervous system disease.
12. History of severe anaphylactic reaction or serious blood dyscrasias.
13. Impaired renal function (ie, creatinine clearance [CLcr] is lower than 30mL/min) at Visit 1.
14. History of sick sinus syndrome without a pacemaker, or atrioventricular (AV) block, or subject has any other clinically significant ECG abnormalities.
15. History sodium channelopathy, such as Brugada syndrome.
16. History of myocardial infarction in the last 3 months.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified