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

• ClinicalTrials.gov Identifier: NCT01465997
• Recruitment Status: Completed
• First Posted: November 6, 2011
• Results First Posted: August 2, 2017
• Last Update Posted: July 18, 2018
• Sponsor: UCB BIOSCIENCES GmbH
• Collaborator: Eden Sarl
• Information provided by (Responsible Party): UCB Pharma ( UCB BIOSCIENCES GmbH )

Tracking Information

• First Submitted Date: November 2, 2011
• First Posted Date: November 6, 2011
• Results First Submitted Date: June 27, 2017
• Results First Posted Date: August 2, 2017
• Last Update Posted Date: July 18, 2018
• Study Start Date: May 2012
• Actual Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 7, 2017)

• Number of Subjects With at Least One Treatment-emergent Adverse Event (AE) During the Treatment Phase (Maximum of 3.5 Years) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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.

Original Primary Outcome Measures (submitted: November 4, 2011)

• 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) ]
• 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) ]
• 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) ]

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Evaluating Long Term Safety of Lacosamide (LCM) to Carbamazepine Controlled-release (CBZ-CR); Initial Monotherapy in Epilepsy Subjects 16 Years and Older
• 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.
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment

Condition

• Epilepsy
• Monotherapy

Intervention

• 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

Study Arms

• 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)

• Publications *: Ben-Menachem E, Dominguez J, Szász J, Beller C, Howerton C, Jensen L, McClung C, Roebling R, Steiniger-Brach B. Long-term safety and tolerability of lacosamide monotherapy in patients with epilepsy: Results from a multicenter, open-label trial. Epilepsia Open. 2021 Sep;6(3):618-623. doi: 10.1002/epi4.12522. Epub 2021 Aug 2.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 27, 2015): 551
• Original Estimated Enrollment (submitted: November 4, 2011): 527
• Actual Study Completion Date: January 2017
• Actual Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Belgium, Bulgaria, Canada, Czechia, Finland, France, Germany, Greece, Hungary, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Mexico, Philippines, Poland, Portugal, Romania, Russian Federation, Slovakia, Spain, Sweden, Switzerland, Thailand, Ukraine, United Kingdom, United States
• Removed Location Countries: Czech Republic

Administrative Information

• NCT Number: NCT01465997
• Other Study ID Numbers: SP0994; 2010-021238-74 ( EudraCT Number )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: UCB Pharma ( UCB BIOSCIENCES GmbH )
• Original Responsible Party: UCB Pharma
• Current Study Sponsor: UCB BIOSCIENCES GmbH
• Original Study Sponsor: UCB Pharma
• Collaborators: Eden Sarl

Investigators

• Study Director: UCB Cares; +1 877 822 9493 (UCB)

• PRS Account: UCB Pharma
• Verification Date: September 2017