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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 June 2013 by UCB, Inc.
Sponsor:
Collaborator:
EDEV S.À.R.L
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT01465997
First received: November 2, 2011
Last updated: June 5, 2013
Last verified: June 2013
History of Changes

November 2, 2011
June 5, 2013
May 2012
December 2014   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01465997 on ClinicalTrials.gov Archive Site
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Evaluating Long Term Safety of Lacosamide (LCM) to Carbamazepine Controlled-release (CBZ-CR); Initial Monotherapy in Epilepsy Subjects 16 Years and Older
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.

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).
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Epilepsy
  • Monotherapy
  • 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
  • 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
  • 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)
    Intervention: Drug: Lacosamide
  • 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)
    Intervention: Drug: Carbamazepine-Controlled Release (CBZ-CR)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
527
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact: UCB Clinical Trial Call Center +1 877 822 9493
Australia,   Belgium,   Canada,   Czech Republic,   Finland,   Germany,   Greece,   Hungary,   Italy,   Korea, Republic of,   Lithuania,   Poland,   Portugal,   Romania,   Russian Federation,   Slovakia,   Spain,   Sweden,   Ukraine,   United Kingdom
 
NCT01465997
SP0994, 2010-021238-74
No
UCB, Inc.
UCB, Inc.
EDEV S.À.R.L
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
UCB, Inc.
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP