Evaluating Long Term Safety of Lacosamide (LCM) to Carbamazepine Controlled-release (CBZ-CR); Initial Monotherapy in Epilepsy Subjects 16 Years and Older

This study is currently recruiting participants.
Verified March 2014 by UCB, Inc.
Sponsor:
Collaborator:
EDEV S.À.R.L
Information provided by (Responsible Party):
UCB, Inc. ( UCB BIOSCIENCES GmbH )
ClinicalTrials.gov Identifier:
NCT01465997
First received: November 2, 2011
Last updated: March 21, 2014
Last verified: March 2014
  Purpose

Compare safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR) as monotherapy in newly or recently newly diagnosed subjects with primary safety variables including spontaneous reports of Adverse Events (AEs), withdrawal of subjects due to AEs, reporting of Serious AEs (SAEs).


Condition Intervention Phase
Epilepsy
Monotherapy
Drug: Lacosamide
Drug: Carbamazepine-Controlled Release (CBZ-CR)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-blind, Double-dummy, Follow up Study Evaluating the Long-term Safety of Lacosamide in Comparison With Controlled-release Carbamazepine Used as Monotherapy in Subjects With Partial-onset or Generalized Tonic-clonic Seizures ≥16 Years of Age Coming From the SP0993 Study.

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • Number of subjects with at least one treatment-emergent Adverse Event (AE) during the Treatment Phase (Maximum of 3.5 Years) [ Time Frame: Duration of the Treatment Phase (Maximum of 3.5 Years) ] [ Designated as safety issue: No ]
  • Number of subjects who withdrew from the study due to a treatment-emergent Adverse Event (AE) during the Treatment Phase (Maximum 3.5 Years) [ Time Frame: Duration of the Treatment Phase (Maximum of 3.5 Years) ] [ Designated as safety issue: No ]
  • Number of subjects with at least one treatment- emergent Serious Adverse Event (SAE) during the Treatment Phase (Maximum of 3.5 years) [ Time Frame: Duration of the Treatment Phase (Maximum of 3.5 Years) ] [ Designated as safety issue: No ]

Estimated Enrollment: 527
Study Start Date: May 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lacosamide
50 and 100 mg tablets of Lacosamide given as 100 mg/day, 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years)
Drug: Lacosamide
50 and 100 mg tablets of Lacosamide given as 100 mg/day, 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years)
Other Name: VIMPAT film-coated tablets
Active Comparator: Carbamazepine-Controlled Release (CBZ-CR)
200 mg tablets of Carbamazepine-CR given as 200 mg/day, 400 mg/day, 600 mg/day, 800 mg/day, 1000 mg/day or 1200 mg/day throughout the Treatment Period (Maximum of 3.5 Years)
Drug: Carbamazepine-Controlled Release (CBZ-CR)
200 mg tablets of Carbamazepine-CR given as 200 mg/day, 400 mg/day, 600 mg/day, 800 mg/day, 1000 mg/day or 1200 mg/day throughout the Treatment Period (Maximum 3.5 Years)
Other Name: Tegretol® Retard Tablets 200 mg

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject/legal representative is considered reliable and capable of adhering to the protocol
  • Subject has remained seizure free and completed the Maintenance Phase of the SP0993; or subject has experienced 1 or more seizures on the first or second target dose during the SP0993 Maintenance Phase
  • Subject is expected to benefit from participation in SP0994 in the opinion of the investigator

Exclusion Criteria:

  • Subject is receiving any investigational drugs or using any experimental devices in addition to LCM or CBZ-CR
  • Subject experienced a seizure at the third target dose during the Evaluation Phase or Maintenance Phase of the SP0993 study
  • Subject is taking benzodiazepines for a non-epilepsy indication
  • Subject meets a withdrawal criterion from the previous study SP0993
  • Subject is experiencing an ongoing SAE from the previous study SP0993
  • Subject has a lifetime history of suicide attempt (including an active 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. Or subject has a positive response (Yes) to either Question 4 or Question 5 of the C-SSRS at Screening in the "Since Last Visit" version
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01465997

Contacts
Contact: UCB Clinical Trial Call Center +1 877 822 9493

  Show 119 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: NCT01465997     History of Changes
Other Study ID Numbers: SP0994, 2010-021238-74
Study First Received: November 2, 2011
Last Updated: March 21, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Finland: Finnish Medicines Agency
Hungary: National Institute of Pharmacy
Italy: The Italian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal: National Pharmacy and Medicines Institute
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Australia: Department of Health and Ageing Therapeutic Goods Administration
Canada: Health Canada
Russia: Ministry of Health of the Russian Federation
South Korea: Korea Food and Drug Administration (KFDA)
Mexico: Secretaria de Salud
Mexico: Federal Commission for Protection Against Health Risks
Ukraine: State Pharmacological Center - Ministry of Health
Greece: National Organization of Medicines
Slovakia: State Institute for Drug Control
Romania: National Agency for Medicines and Medical Devices
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
United States: Food and Drug Administration

Keywords provided by UCB, Inc.:
Lacosamide

Additional relevant MeSH terms:
Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Carbamazepine
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on April 17, 2014