Trial Comparing the Efficacy and Safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR); Initial Monotherapy in Epilepsy; Subjects Aged 16 and Older

• Register: ClinicalTrials.gov
• Last refreshed on: 20 May 2013
• Main ID: NCT01243177
• Date of registration: 16/11/2010
• Primary sponsor: UCB BIOSCIENCES GmbH
• Public title: Trial Comparing the Efficacy and Safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR); Initial Monotherapy in Epilepsy; Subjects Aged 16 and Older SP0993
• Scientific title: A Multicenter, Double-blind, Double-dummy, Randomized, Positive- Controlled Study Comparing the Efficacy and Safety of Lacosamide (200 to 600 mg/Day) to Controlled Release Carbamazepine (400 to 1200 mg/Day), Used as Monotherapy in Subjects (= 16 Years) Newly or Recently Diagnosed With Epilepsy and Experiencing Partial-onset or Generalized Tonic-clonic Seizures.
• Date of first enrolment: April 2011
• Target sample size: 878
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01243177
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Countries of recruitment

Australia, Belgium, Bulgaria, Canada, Czech Republic, Finland, France, Germany, Greece, Hungary, Italy, Korea, Republic of, Latvia, Lithuania, Mexico, Poland, Portugal, Romania, Russian Federation, Slovakia, Spain, Sweden, Switzerland, Thailand, Ukraine, United Kingdom, United States

Contacts

• Name: UCB Clinical Trial Call Center

• Name: UCB Clinical Trial Call Center
• Affiliation: [phone] (UCB)

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subject able to comply with study requirements

- Subject is 16 years and older (female; male). Minors will be included in countries
only if legally permitted

- Subject has newly or recently diagnosed Epilepsy experiencing partial onset seizures
(POS) or generalized tonic-clonic seizures with at least 2 unprovoked seizures
separated by 48 hours in the 12 months preceding Visit 1 out of which at least 1
seizure occured 3 months preceding Visit 1

- Subject has had an Electroencephalogram (EEG) and a brain Computed Tomography (CT)
scan or Magnetic Resonance Imaging (MRI) exam of the brain within the past 12 months.
If the EEG and brain CT scan or MRI exam were not performed prior to Visit 1, they
need to be completed and results must be available prior to randomization at Visit 2

Exclusion Criteria:

- Subject has a history or presence of seizures of other types than partial-onset (IA,
IB, IC with clear focal origin) and generalized tonic-clonic (without clear focal
origin) seizures (eg, myoclonic, absence)

- Subject has a history or presence of seizures occurring only in clustered patterns,
defined as repeated seizures occurring over a short period of time (ie, < 20 minutes)
with or without function regained between 2 ictal events

- Subject has a history, clinical, or Electroencephalogram (EEG) finding suggestive of
Idiopathic Generalized Epilepsy (IGE) at randomization

- Subject has current or previous diagnosis of pseudoseizures, conversion disorders,
or other nonepileptic ictal events that could be confused with seizures based on
expert opinion and/or EEG evidence

- Subject has any medical or psychiatric condition

- Subject has a lifetime history of suicide attempt (including an actual attempt,
interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6
months as indicated by a positive response (Yes) to either Question 4 or Question 5
of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening

- Subject has received treatment with Phenobarbital or Primidone within 28 days prior
to Visit 1

- Subject is taking Benzodiazepines for a nonepilepsy indication

- Subject has been treated for Epilepsy with any Antiepileptic Drug (AED) (including
Benzodiazepines) in the last 6 months before Visit. However, acute and subacute
seizure treatment is accepted with a maximum of 2 weeks duration and if treatment was
stopped at least 3 days prior to randomization

- Prior use of Felbamate or Vigabatrin is not allowed

- Benzodiazepines as rescue therapy for Epilepsy may have been used as needed in this
time period, but not more frequently than once per week

- Subject has a medical condition that could reasonably be expected to interfere with
drug absorption, distribution, metabolism, or excretion, has a history of alcohol or
drug abuse within the previous 2 years

- Asian ancestry and tests positive for HLA-B*1502 allele

- Asian ancestry and tests positive for HLA-A*3101 allele



Age minimum: 16 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Epilepsy

Monotherapy

Intervention(s)

Drug: Carbamazepine-Controlled Release

Drug: Lacosamide

Primary Outcome(s)

Number of subjects who withdraw from the study due to a treatment-emergent Adverse Event (AE) during the Treatment Phase (up to 113 weeks) [Time Frame: Duration of the Treatment Phase (up to 113 weeks)]

Number of subjects with at least one treatment- emergent Serious Adverse Event (SAE) during the Treatment Phase (up to 113 weeks) [Time Frame: Duration of the Treatment Phase (up to 113 weeks)]

Number of subjects with at least one treatment-emergent Adverse Event (AE) during the Treatment Phase (up to 113 weeks) [Time Frame: Duration of the Treatment Phase (up to 113 weeks)]

Proportion of subjects remaining seizure free for 6 consecutive months (26 consecutive weeks) of treatment following stabilization at the last evaluated dose for each subject [Time Frame: 6 consecutive months (26 consecutive weeks) of treatment following stabilization at the last evaluated dose for each subject]

Secondary Outcome(s)

Proportion of subjects remaining seizure free for 12 consecutive months (52 consecutive weeks) following stabilization at the last evaluated dose for each subject [Time Frame: 12 consecutive months of treatment following stabilization at the last evaluated dose for each subject]

Secondary ID(s)

2010-019765-28

SP0993

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

EDEV S.À.R.L