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

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 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:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy

MedlinePlus related topics: Epilepsy

Drug Information available for: Carbamazepine Lacosamide

U.S. FDA Resources

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:	December 2014
Estimated Primary Completion Date:	December 2014 (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 reliable and capable of adhering to the protocol
Subject has remained seizures free
Subject completed Maintenance Phase of the SP0993 [NCT01243177] study
Subject has experienced one or more seizures on the first or second target dose during the SP0993 [NCT01243177] Maintenance Phase
Subject is expected to benefit from participation in SP0994 in the opinion of the investigator

Exclusion Criteria:

Subject experienced a seizure at the third target dose during the Evaluation Phase or Maintenance Phase of SP0993 [NCT01243177]
Subject is taking Benzodiazepines for a nonepilepsy indication
Subjects meets a withdrawal criterion from the previous study SP0993 [NCT01243177]
Subject is experiencing an ongoing Serious Adverse Event (SAE) from the previous study SP0993 [NCT01243177]
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 64 Study Locations

Sponsors and Collaborators

UCB, Inc.

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.
ClinicalTrials.gov Identifier:	NCT01465997 History of Changes
Other Study ID Numbers:	SP0994, 2010-021238-74
Study First Received:	November 2, 2011
Last Updated:	May 6, 2013
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 Medicines 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 United States: Food and Drug Administration

Keywords provided by UCB, Inc.:

Lacosamide
VIMPAT
Epilepsy
Monotherapy

Additional relevant MeSH terms:

Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
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 May 16, 2013