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

• Register: EUCTR
• Last refreshed on: 25 November 2019
• Main ID: EUCTR2011-003100-21-HU
• Date of registration: 29/04/2015
• Prospective Registration: Yes
• Primary sponsor: UCB BIOSCIENCES, Inc.
• Public title: 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
• Scientific title: A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF LACOSAMIDE AS ADJUNCTIVE THERAPY FOR UNCONTROLLED PRIMARY GENERALIZED TONIC-CLONIC SEIZURES IN SUBJECTS WITH IDIOPATHIC GENERALIZED EPILEPSY
• Date of first enrolment: 23/06/2015
• Target sample size: 250
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-003100-21
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Belgium, Brazil, Bulgaria, China, Czech Republic, France, Germany, Hungary, Israel, Italy, Japan, Korea, Republic of, Mexico, Poland, Portugal, Romania, Russian Federation, Slovakia, Spain, Taiwan, Turkey, United States

Contacts

• Name: Clin Trial Reg & Results disclosure
• Affiliation: UCB BIOSCIENCES GmbH

• Name: Clin Trial Reg & Results disclosure
• Affiliation: UCB BIOSCIENCES GmbH

Key inclusion & exclusion criteria

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 nonbenzodiazepine 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, e.g. 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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Epilepsy
MedDRA version: 20.0 Level: LLT Classification code 10071096 Term: Idiopathic generalized epilepsy System Organ Class: 100000004852

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

Trade Name: Vimpat 50 mg film-coated tablets
Product Name: Lacosamide
Product Code: SPM927
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: LACOSAMIDE
Current Sponsor code: SPM 927
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Coated tablet
Route of administration of the placebo: Oral use

Trade Name: Vimpat 10mg/ml Oral Solution
Product Name: Lacosamide
Product Code: SPM927
Pharmaceutical Form: Oral solution
INN or Proposed INN: LACOSAMIDE
Current Sponsor code: SPM 927
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Oral solution
Route of administration of the placebo: Oral use

Primary Outcome(s)

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(s)

Secondary end point(s): Seizure freedom for primary generalized tonic clonic (PGTC) seizures

Time to the first primary generalized tonic clonic (PGTC) seizure

Incidence of Treatment Emergent Adverse Events (TEAEs) as reported spontaneously by the subject and/or caregiver or observed by the investigator

Incidence of Serious Adverse Events (SAEs) as reported spontaneously by the subject and/or caregiver or observed by the investigator

Timepoint(s) of evaluation of this end point: 24-week Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24)

During Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24)

From Visit 1 (Week -4) to End of Study Period (up to Week 36)

From Visit 1 (Week -4) to End of Study Period (up to Week 36)

Secondary ID(s)

SP0982

2011-003100-21-PT

Source(s) of Monetary Support

UCB BIOSCIENCES, Inc.

Ethics review

Status: Approved
Approval date:
Contact: