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Safety and Efficacy of Lacosamide as Additional Therapy in Patients Suffering From Epileptic Tonic Clonic Seizures (VALUE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02408549
Recruitment Status : Active, not recruiting
First Posted : April 3, 2015
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES, Inc. )

Tracking Information
First Submitted Date  ICMJE March 31, 2015
First Posted Date  ICMJE April 3, 2015
Last Update Posted Date July 7, 2020
Actual Study Start Date  ICMJE August 2015
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 10, 2016)
  • Number of subjects experiencing at least one Adverse Event (AE) during the study (up to 5 years) [ Time Frame: During the study (up to 5 years) ]
    Adverse Events will be reported spontaneously by the subject and/or caregiver or observed by the investigator.
  • Number of subjects withdrawing due to Adverse Events (AEs) during the study (up to 5 years) [ Time Frame: During the study (up to 5 years) ]
    Adverse Events will be reported spontaneously by the subject and/or caregiver or observed by the investigator.
  • Incidence of new seizure types during the Treatment Period [ Time Frame: During the Treatment Period (up to 5 years) ]
  • Number of subjects with an increase of up to 25% in days with absence seizures per 28 days during the Treatment Period as compared to the Prospective Baseline (of study SP0982) [ Time Frame: From Visit 1 to End of Treatment Period (up to 5 years) ]
  • Number of subjects with an increase of >25% to 50% in days with absence seizures per 28 days during the Treatment Period as compared to the Prospective Baseline (of study SP0982) [ Time Frame: From Visit 1 to End of Treatment Period (up to 5 years) ]
  • Number of subjects with an increase of >50% to 75% in days with absence seizures per 28 days during the Treatment Period as compared to the Prospective Baseline (of study SP0982) [ Time Frame: From Visit 1 to End of Treatment Period (up to 5 years) ]
  • Number of subjects with an increase of >75% in days with absence seizures per 28 days during the Treatment Period as compared to the Prospective Baseline (of study SP0982) [ Time Frame: From Visit 1 to End of Treatment Period (up to 5 years) ]
  • Number of subjects with an increase of up to 25% in days with myoclonic seizures per 28 days during the Treatment Period as compared to the Prospective Baseline (of study SP0982) [ Time Frame: From Visit 1 to End of Treatment Period (up to 5 years) ]
  • Number of subjects with an increase of >25% to 50% in days with myoclonic seizures per 28 days during the Treatment Period as compared to the Prospective Baseline (of study SP0982) [ Time Frame: From Visit 1 to End of Treatment Period (up to 5 years) ]
  • Number of subjects with an increase of >50% to 75% in days with myoclonic seizures per 28 days during the Treatment Period as compared to the Prospective Baseline (of study SP0982) [ Time Frame: From Visit 1 to End of Treatment Period (up to 5 years) ]
  • Number of subjects with an increase of >75% in days with myoclonic seizures per 28 days during the Treatment Period as compared to the Prospective Baseline (of study SP0982) [ Time Frame: From Visit 1 to End of Treatment Period (up to 5 years) ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 31, 2015)
  • Number of subjects experiencing at least one Adverse Event (AE) during the study (up to 5 years) [ Time Frame: During the study (up to 5 years) ]
    Adverse Events will be reported spontaneously by the subject/ caregiver or observed by the investigator.
  • Number of subjects withdrawing due to Adverse Events (AEs) during the study (up to 5 years) [ Time Frame: During the study (up to 5 years) ]
    Adverse Events will be reported spontaneously by the subject/ caregiver or observed by the investigator.
  • Number of subjects experiencing at least one Serious Adverse Event (SAE) [ Time Frame: During the study (up to 5 years) ]
    Serious Adverse Events will be reported spontaneously by the subject/ caregiver or observed by the investigator.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2018)
  • Percent change in Primary Generalized Tonic-clonic (PGTC) seizure frequency per 28 days from Combined Baseline [ Time Frame: From Combined Baseline until Termination Visit (up to 5 years) ]
    Percent change in PGTC seizure frequency per 28 days from Combined Baseline, where Combined Baseline is defined as the combined 12-week Historical Baseline and 4-week Prospective Baseline periods immediately prior to randomization in the parent study (SP0982).
  • Percentage of treatment-emergent marked abnormalities in hematology parameters [ Time Frame: During the study (up to 5 years) ]
  • Percentage of treatment-emergent marked abnormalities in chemistry parameters [ Time Frame: During the study (up to 5 years) ]
  • Percentage of treatment-emergent marked abnormalities in 12-lead electrocardiogram (ECGs) [ Time Frame: During the study (up to 5 years) ]
  • Percentage of treatment-emergent marked abnormalities in vital sign measurements [ Time Frame: During the study (up to 5 years) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 31, 2015)
Percent change in Primary Generalized Tonic-clonic (PGTC) seizure frequency per 28 days from Baseline [ Time Frame: 28 days from Baseline ]
Percent change in PGTC seizure frequency per 28 days from Baseline, where Baseline is defined as the 12-week Historical Baseline and 4-week Prospective Baseline periods immediately prior to randomization in the parent study (SP0982).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Lacosamide as Additional Therapy in Patients Suffering From Epileptic Tonic Clonic Seizures
Official Title  ICMJE An Open-label, Multicenter Extension Study to Evaluate the Long-term Safety and Efficacy of Lacosamide as Adjunctive Therapy for Uncontrolled Primary Generalized Tonic Clonic Seizures in Subjects With Idiopathic Generalized Epilepsy
Brief Summary Assessment of long-term safety and efficacy of oral lacosamide (LCM) as an adjunctive therapy for uncontrolled primary generalized tonic-clonic (PGTC) seizures in subjects >= 4 years of age with idiopathic generalized epilepsy (IGE). This study will enroll subjects from the LCM SP0982 (NCT02408523) study.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Epilepsy
Intervention  ICMJE
  • Drug: Lacosamide Tablet
    • Active substance: Lacosamide
    • Pharmaceutical form: Tablet
    • Concentration: 50 mg and 100 mg
    • Route of Administration: oral administration
    Other Name: Vimpat
  • Drug: Lasosamide Oral Solution
    • Active substance: Lacosamide
    • Pharmaceutical form: Oral solution
    • Concentration: 10 mg/ml
    • Route of Administration: Oral administration
    Other Name: Vimpat
Study Arms  ICMJE Experimental: Lacosamide

Start dose

SP982 completers at V1:

  • LCM 10 mg/kg/day for pediatric subjects weighing <30 kg
  • LCM 8 mg/kg/day for pediatric subjects weighing ≥ 30kg to <50 kg
  • LCM 400 mg/day (200 mg bid) for adult subjects (≥18 years of age) or pediatric subjects weighing ≥50 kg

SP982 Baseline failures at V1:

  • LCM 2 mg/kg/day for pediatric subjects weighing <50 kg
  • LCM 100 mg/day (50 mg bid) for adult subjects (≥18 years of age) or pediatric subjects weighing ≥50 kg

Oral solution (pediatric subjects <50 kg):

  • Minimum LCM dose: 4 mg/kg/day
  • Maximum LCM dose: 12 mg/kg/day

Tablets (pediatric subjects ≥50kg):

  • Minimum LCM dose: 200 mg/day
  • Minimum LCM dose: 600 mg/day

Tablets (adult subjects):

  • Minimum LCM dose: 200 mg/day
  • Maximum LCM dose: 800 mg/day
Interventions:
  • Drug: Lacosamide Tablet
  • Drug: Lasosamide Oral Solution
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 21, 2019)
239
Original Estimated Enrollment  ICMJE
 (submitted: March 31, 2015)
200
Estimated Study Completion Date  ICMJE February 2024
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

-Subject must have completed or be an eligible Baseline failure from the parent study (SP0982). Note: Other subjects screened for SP0982 may be considered for roll-over to EP0012 if the investigator considers that the subject could benefit from treatment with open-label lacosamide (LCM) and based on prior discussion with and approval from the UCB Study Physician or representative.

Exclusion Criteria:

  • Subject is receiving any investigational drugs or using any experimental devices in addition to Lacosamide (LCM)
  • Subject meets the withdrawal criteria for SP0982 or is experiencing an ongoing serious adverse event (SAE)
  • Subject has an active suicidal ideation as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the "Since Last Visit" version of the Columbia-Suicide Severity Rating Scale (C-SSRS)
  • Subject has >=2x upper limit of normal (ULN) of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or >ULN total bilirubin (≥1.5xULN total bilirubin if known Gilbert's syndrome). If subject has elevations only in total bilirubin that are >ULN and <1.5xULN, fractionate bilirubin to identify possible undiagnosed Gilbert's syndrome (ie, direct bilirubin <35%).

For randomized subjects with a Baseline result >ULN for ALT, AST, ALP, or total bilirubin, a Baseline diagnosis and/or the cause of any clinically meaningful elevation must be understood and recorded in the Case Report form (CRF).

If subject has >ULN ALT, AST, or ALP that does not meet the exclusion limit at screening, repeat the tests, if possible, prior to dosing to ensure there is no further ongoing clinically relevant increase. In case of a clinically relevant increase, inclusion of the subject must be discussed with the Medical Monitor. Tests that result in ALT, AST, or ALP up to 25% above the exclusion limit may be repeated once for confirmation. This includes re-screening.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Brazil,   Bulgaria,   China,   Czechia,   France,   Germany,   Hungary,   Israel,   Italy,   Japan,   Korea, Republic of,   Mexico,   Poland,   Portugal,   Romania,   Russian Federation,   Slovakia,   Spain,   Taiwan,   United States
Removed Location Countries Belgium,   Czech Republic,   Turkey
 
Administrative Information
NCT Number  ICMJE NCT02408549
Other Study ID Numbers  ICMJE EP0012
2012-001770-29 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UCB Pharma ( UCB BIOSCIENCES, Inc. )
Study Sponsor  ICMJE UCB BIOSCIENCES, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: UCB Cares +18445992273 (UCB)
PRS Account UCB Pharma
Verification Date July 2020

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