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)
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ClinicalTrials.gov Identifier: NCT01243177 |
Recruitment Status
:
Completed
First Posted
: November 18, 2010
Results First Posted
: February 23, 2016
Last Update Posted
: October 26, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Epilepsy Monotherapy | Drug: Lacosamide Drug: Carbamazepine-Controlled Release | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 888 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official 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. |
Study Start Date : | April 2011 |
Actual Primary Completion Date : | July 2015 |
Actual Study Completion Date : | August 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: Lacosamide |
Drug: Lacosamide
Lacosamide:
Other Name: Vimpat®
|
Active Comparator: Carbamazepine-Controlled Release (CBZ-CR) |
Drug: Carbamazepine-Controlled Release
Carbamazepine-CR:
Other Name: Tegretol® Retard Tablets 200 mg
|
- Proportion of Subjects in the Full Analysis Set (FAS) 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 ]The proportion of subjects remaining seizure free for 6 months (26 weeks) was estimated using Kaplan-Meier methods.
- Proportion of Subjects in the Per Protocol Set (PPS) 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 ]The proportion of subjects remaining seizure free for 6 months (26 weeks) was estimated using Kaplan-Meier methods.
- 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) ]An Adverse Event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment-emergent AEs were defined as AEs that started on or after the date of first dose of study medication and within 30 days following the date of final study medication administration, or AEs whose intensity worsened on or after the date of first dose of study medication and within 30 days following the date of last dose.
- 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) ]An Adverse Event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment-emergent AEs were defined as AEs that started on or after the date of first dose of study medication and within 30 days following the date of final study medication administration, or AEs whose intensity worsened on or after the date of first dose of study medication and within 30 days following the date of last dose.
- 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) ]
An Adverse Event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
A Serious Adverse Event must meet 1 or more predefined criteria like death, life-threatening, etc. Treatment-emergent AEs were defined as AEs that started on or after the date of first dose of study medication and within 30 days following the date of final study medication administration, or AEs whose intensity worsened on or after the date of first dose of study medication and within 30 days following the date of last dose.
- 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 ]The proportion of subjects remaining seizure free for 12 months (52 weeks) was estimated using Kaplan-Meier methods.

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Ages Eligible for Study: | 16 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01243177

Study Director: | UCB Cares | +1 877 822 9493 (UCB) |
Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | UCB BIOSCIENCES GmbH |
ClinicalTrials.gov Identifier: | NCT01243177 History of Changes |
Other Study ID Numbers: |
SP0993 2010-019765-28 ( EudraCT Number ) |
First Posted: | November 18, 2010 Key Record Dates |
Results First Posted: | February 23, 2016 |
Last Update Posted: | October 26, 2017 |
Last Verified: | October 2017 |
Keywords provided by UCB Pharma ( UCB BIOSCIENCES GmbH ):
Lacosamide Vimpat® Epilepsy Monotherapy Velocity |
Additional relevant MeSH terms:
Lacosamide Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases Carbamazepine Anticonvulsants Antimanic Agents Tranquilizing Agents Central Nervous System Depressants |
Physiological Effects of Drugs Psychotropic Drugs Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Cytochrome P-450 CYP3A Inducers Cytochrome P-450 Enzyme Inducers Molecular Mechanisms of Pharmacological Action |