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Trial record 1 of 1 for:    NCT02408549
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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 : May 20, 2022
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES, Inc. )

Brief Summary:
Assessment of long-term safety and efficacy of oral lacosamide (LCM) as an adjunctive therapy for uncontrolled primary generalized tonic-clonic seizures (PGTCS) in subjects >= 4 years of age with idiopathic generalized epilepsy (IGE). This study will enroll subjects from the LCM SP0982 [NCT02408523] study.

Condition or disease Intervention/treatment Phase
Epilepsy Drug: Lacosamide Tablet Drug: Lacosamide Oral Solution Phase 3

Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 239 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 2015
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures
Drug Information available for: Lacosamide

Arm Intervention/treatment
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
Drug: Lacosamide Tablet
  • Active substance: Lacosamide
  • Pharmaceutical form: Tablet
  • Concentration: 50 mg and 100 mg
  • Route of Administration: oral administration
Other Names:
  • Vimpat
  • LCM

Drug: Lacosamide Oral Solution
  • Active substance: Lacosamide
  • Pharmaceutical form: Oral solution
  • Concentration: 10 mg/ml
  • Route of Administration: Oral administration
Other Names:
  • Vimpat
  • LCM




Primary Outcome Measures :
  1. Number of subjects with treatment-emergent adverse events (TEAEs) over the duration of the Treatment Period [ Time Frame: During the Treatment Period (up to 5 years) ]
    Adverse Events will be reported spontaneously by the subject and/or caregiver or observed by the investigator.

  2. Number of subjects withdrawn due to TEAEs [ Time Frame: During the Treatment Period (up to 5 years) ]
    Adverse Events will be reported spontaneously by the subject and/or caregiver or observed by the investigator.

  3. Number of subjects with new appearance of absence and/or myoclonic seizures during the Treatment Period [ Time Frame: During the Treatment Period (up to 5 years) ]
    Incidence of new seizure types in the EP0012 Treatment Period for all subjects who haven't had that seizure type in combined baseline or history before taking lacosamide (LCM).

  4. 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) ]
  5. 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) ]
  6. 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) ]
  7. 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) ]
  8. 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) ]
  9. 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) ]
  10. 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) ]
  11. 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) ]
  12. Percentage of subjects with at least 50% worsening in days with absence seizures [ Time Frame: From Visit 1 to End of Treatment Period (up to 5 years) ]
  13. Percentage of subjects with at least 50% worsening in days with myoclonic seizures [ Time Frame: From Visit 1 to End of Treatment Period (up to 5 years) ]

Secondary Outcome Measures :
  1. Percentage of treatment-emergent marked abnormalities in hematology parameters [ Time Frame: During the study (up to 5 years) ]
  2. Percentage of treatment-emergent marked abnormalities in chemistry parameters [ Time Frame: During the study (up to 5 years) ]
  3. Percentage of treatment-emergent marked abnormalities in 12-lead electrocardiogram (ECGs) [ Time Frame: During the study (up to 5 years) ]
  4. Percentage of treatment-emergent marked abnormalities in vital sign measurements [ Time Frame: During the study (up to 5 years) ]
  5. Percent change in Primary Generalized Tonic-clonic seizure (PGTCS) frequency per 28 days from Combined Baseline [ Time Frame: From Combined Baseline until Termination Visit (up to 5 years) ]
    Percent change in PGTCS 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   4 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

-Subject must have completed or be an eligible Baseline failure from the parent study (SP0982 [NCT02408523]). 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 all subjects who entered EP0012 directly 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 electronic Case Report form (eCRF). Tests that result in ALT, AST, or ALP up to 25% above the exclusion limit may be repeated once for confirmation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02408549


Locations
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Sponsors and Collaborators
UCB BIOSCIENCES, Inc.
Investigators
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Study Director: UCB Cares 001 844 599 2273 (UCB)
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Responsible Party: UCB BIOSCIENCES, Inc.
ClinicalTrials.gov Identifier: NCT02408549    
Other Study ID Numbers: EP0012
2012-001770-29 ( EudraCT Number )
First Posted: April 3, 2015    Key Record Dates
Last Update Posted: May 20, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
Access Criteria: Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
URL: https://www.Vivli.org

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by UCB Pharma ( UCB BIOSCIENCES, Inc. ):
Lacosamide
Vimpat
Epilepsy
Children
Primary Generalized Tonic-Clonic seizures
Idiopathic Generalized Epilepsy
Adults
Additional relevant MeSH terms:
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Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Lacosamide
Anticonvulsants
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action