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)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
EDEV S.À.R.L
Information provided by (Responsible Party):
UCB, Inc. ( UCB BIOSCIENCES GmbH )
ClinicalTrials.gov Identifier:
NCT01243177
First received: November 16, 2010
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

Compare efficacy and safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR) as monotherapy in newly or recently newly diagnosed subjects with a primary efficacy endpoint of 6-month seizure freedom. Noninferiority design to show a similar risk/benefit balance between Lacosamide (LCM) and Carbamazepine-CR (CBZ-CR).


Condition Intervention Phase
Epilepsy
Monotherapy
Drug: Lacosamide
Drug: Carbamazepine-Controlled Release
Phase 3

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
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.

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 878
Study Start Date: April 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lacosamide Drug: Lacosamide

Lacosamide:

  • Strengths: 50 mg / 100 mg
  • Form: tablets
  • Dosage: 100 mg, 200 mg; 300 mg; 400 mg; 500 mg; 600 mg/ total daily dose, administered twice daily in divided doses
  • Duration: up to 118 weeks
Other Name: Vimpat®
Active Comparator: Carbamazepine-Controlled Release (CBZ-CR) Drug: Carbamazepine-Controlled Release

Carbamazepine-CR:

  • Strengths: 200 mg
  • Form: tablets
  • Dosage: 200 mg; 400 mg; 600 mg; 800 mg; 1000 mg; 1200 mg/ total daily dose, administered twice daily in divided doses
  • Duration: up to 118 weeks
Other Name: Tegretol® Retard Tablets 200 mg

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01243177

  Show 192 Study Locations
Sponsors and Collaborators
UCB BIOSCIENCES GmbH
EDEV S.À.R.L
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: UCB, Inc. ( UCB BIOSCIENCES GmbH )
ClinicalTrials.gov Identifier: NCT01243177     History of Changes
Other Study ID Numbers: SP0993, 2010-019765-28
Study First Received: November 16, 2010
Last Updated: July 24, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Finland: Finnish Medicines Agency
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
Hungary: National Institute of Pharmacy
Italy: The Italian Medicines Agency
Mexico: Federal Commission for Protection Against Health Risks
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal: National Pharmacy and Medicines Institute
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Slovakia: State Institute for Drug Control
Spain: Agencia Española de Medicamentos y Productos Sanitarios
South Korea: Korea Food and Drug Administration (KFDA)
Sweden: Medical Products Agency
Ukraine: State Pharmacological Center - Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Switzerland: Swissmedic
Thailand: Ministry of Public Health
Philippines: Bureau of Food and Drugs
Lithuania: State Medicine Control Agency - Ministry of Health
Bulgaria: Bulgarian Drug Agency
Latvia: State Agency of Medicines
Japan: Pharmaceuticals and Medical Devices Agency
United States: Food and Drug Administration

Keywords provided by UCB, Inc.:
Lacosamide
Vimpat®
Epilepsy
Monotherapy
Velocity

Additional relevant MeSH terms:
Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Lacosamide
Carbamazepine
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on August 01, 2014