A study to assess the safety and efficacy of Lacosamide versus placebo (a pill without active medication) in patients with idiopathic generalised epilepsy who are already taking anti-epileptic medications

Phase 1

Conditions: Epilepsy
MedDRA version: 20.0Level: LLTClassification code 10071096Term: Idiopathic generalized epilepsySystem Organ Class: 100000004852
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2011-003100-21-Outside-EU/EEA

Lead Sponsor: CB BIOSCIENCES, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 242

Inclusion Criteria

• Subject with a confirmed diagnosis at least 24 weeks prior to Visit 1 and a disease onset prior to 30 years of age, consistent with idiopathic generalized epilepsy (IGE) experiencing primary generalized tonic-clonic (PGTC) seizures (Type IIE) that are classifiable according to the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures (ILAE, 1981).

• Subject has =3 PGTC seizures during the 16-week Combined Baseline (12-week Historical Baseline plus 4-week Prospective Baseline)

• If a brain magnetic resonance imaging (MRI)/computed tomography (CT) scan has been performed, there must be no evidence of any progressive abnormality or any lesion likely to be associated with partial-onset seizures.

• Subject has been maintained on a stable dose regimen of 1 to 2 non-benzodiazepine marketed Anti-epileptic drugs (AEDs) with no benzodiazepine AEDs OR 1 benzodiazepine marketed AED with 1 to 2 non-benzodiazepine marketed AEDs for at least 28 days prior to Visit 1 with or without additional concurrent stable Vagus nerve stimulation (VNS).

• Subjects are required to have had an electroencephalogram (EEG) report consistent with IGE (eg, generalized =3Hz epileptiform discharges and a normal EEG background) confirmed by a Central Reviewer.
Are the trial subjects under 18? yes
Number of subjects for this age range: 60
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 170
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

• Subject is receiving any investigational drugs or using any experimental devices in addition to Lacosamide (LCM)
• Subject meets the withdrawal criteria for SP0982 or is experiencing an ongoing serious adverse event (SAE)
•Subject has >=2x upper limit of normal (ULN) of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or >ULN total bilirubin (>=1.5xULN total bilirubin if known Gilbert's syndrome). If subject has elevations only in total bilirubin that are >ULN and <1.5xULN, fractionate bilirubin to identify possible undiagnosed Gilbert's syndrome (ie, direct bilirubin <35%).
• History of partial onset seizures or EEG findings indicating partial onset seizures
• Symptomatic generalized epilepsy, (eg, Lennox-Gastaut Syndrome
typically presenting with seizures including tonic seizures), some other related syndrome like Doose’s syndrome (typically presenting with myoclonic-atonic seizures) or evidence of both focal and generalized epilepsy.
• Lifetime history of suicide attempt, or suicidal ideation in past 6 months
• Women of child bearing potential must practice contraception according to protocol requirements
• Regular use of clozapine, monoamine oxidase A (MAO-A) inhibitors, barbiturates (for indication other than epilepsy) within 28 days prior to Visit 1
• Use of Felbamate or Vigabatrin within last 6 months
• Subject is on a ketogenic diet that has either changed within the 4 weeks prior to Visit 1 or is expected to change during the study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate the efficacy of oral lacosamide (LCM) vs placebo as adjunctive therapy for uncontrolled primary generalized tonic-clonic (PGTC) seizures in subjects with idiopathic generalized epilepsy (IGE) currently taking 1 to 3 concomitant anti-epileptic drugs (AEDs) independent of the number of prior failed AEDs;Secondary Objective: To assess the safety and tolerability of lacosamide (LCM) in subjects with idiopathic generalized epilepsy (IGE) with uncontrolled primary generalized tonic-clonic (PGTC) seizures;Primary end point(s): Time to the second primary generalized tonic clonic (PGTC) seizure;Timepoint(s) of evaluation of this end point: 24-week Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24)

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: 24-week Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24)<br><br>During Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24)<br><br>From Visit 1 (Week -4) to End of Study Period (up to Week 36)<br><br>From Visit 1 (Week -4) to End of Study Period (up to Week 36);Secondary end point(s): Seizure freedom for primary generalized tonic clonic (PGTC) seizures<br><br>Time to the first primary generalized tonic clonic (PGTC) seizure<br><br>Incidence of Treatment Emergent Adverse Events (TEAEs) as reported spontaneously by the subject and/or caregiver or observed by the investigator<br><br>Incidence of Serious Adverse Events (SAEs) as reported spontaneously by the subject and/or caregiver<br>or observed by the investigator

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