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

UCB

Status and phase: Completed; Phase 3

Conditions: Epilepsy; Monotherapy

Treatments: Drug: Carbamazepine-Controlled Release (CBZ-CR); Drug: Lacosamide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01465997

SP0994

2010-021238-74 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 551 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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551 participants in 2 patient groups

Lacosamide

Experimental group

Description:

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)

Treatment:

Drug: Lacosamide

Carbamazepine-Controlled Release (CBZ-CR)

Active Comparator group

Description:

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)

Treatment:

Drug: Carbamazepine-Controlled Release (CBZ-CR)