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

Phase 3

Completed

• Conditions: Epilepsy; Monotherapy
• Interventions: Drug: Carbamazepine-Controlled Release (CBZ-CR); Drug: Lacosamide

• Registration Number: NCT01465997
• Lead Sponsor: UCB BIOSCIENCES GmbH

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-11-02
• Study First Submitted QC: 2011-11-04
• Study First Posted: 2011-11-06
• Study Start: 2012-05
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Results First Submitted: 2017-06-27
• Results First Submitted QC: 2017-07-07
• Results First Posted: 2017-08-02
• Status Verified: 2017-09
• Last Update Submitted: 2018-06-21
• Last Update Posted: 2018-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 551

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Carbamazepine-Controlled Release (CBZ-CR)	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)
Lacosamide	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)

Primary Outcome Measures

Name	Time	Method
Number of Subjects With at Least One Treatment-emergent Adverse Event (AE) During the Treatment Phase (Maximum of 3.5 Years)	Up to 3.5 Years (Duration of the Treatment Phase)	Treatment-emergent AEs were defined as those events which started on or after the date of first dose of SP0994 study medication, or events in which severity worsened on or after the date of first dose of SP0994 study medication. AEs which occurred within 30 days after last dose of study medication were considered treatment emergent.
Number of Subjects Who Withdrew From the Study Due to a Treatment-emergent Adverse Event (AE) During the Treatment Phase (Maximum 3.5 Years)	Up to 3.5 Years (Duration of the Treatment Phase)	Treatment-emergent AEs were defined as those events which started on or after the date of first dose of SP0994 study medication, or events in which severity worsened on or after the date of first dose of SP0994 study medication. AEs which occurred within 30 days after last dose of study medication were considered treatment emergent.
Number of Subjects With at Least One Treatment-emergent Serious Adverse Event (SAE) During the Treatment Phase (Maximum of 3.5 Years)	Up to 3.5 Years (Duration of the Treatment Phase)	A Serious Adverse Event is any untoward medical occurrence that at any dose results in death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity is a congenital anomaly/birth defect.

Trial Locations

Locations (150)

786; 🇺🇸 Alabaster, Alabama, United States

799; 🇺🇸 Huntsville, Alabama, United States

777; 🇺🇸 Little Rock, Arkansas, United States

789; 🇺🇸 Panama City, Florida, United States

776; 🇺🇸 Port Charlotte, Florida, United States

873; 🇺🇸 Raleigh, North Carolina, United States

794; 🇺🇸 Oklahoma City, Oklahoma, United States

881; 🇺🇸 Mansfield, Texas, United States

790; 🇺🇸 Madison, Wisconsin, United States

104; 🇦🇺 Chatswood, Australia

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