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

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ClinicalTrials.gov Identifier: NCT02408549
Recruitment Status : Active, not recruiting
First Posted : April 3, 2015
Last Update Posted : June 24, 2019
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 (PGTC) seizures 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: Lasosamide Oral Solution Phase 3

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 239 participants
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 : January 2024
Estimated Study Completion Date : March 2024

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 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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. Incidence of new seizure types during the Treatment Period [ Time Frame: During the Treatment Period (up to 5 years) ]
  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) ]

Secondary Outcome Measures :
  1. 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).

  2. Percentage of treatment-emergent marked abnormalities in hematology parameters [ Time Frame: During the study (up to 5 years) ]
  3. Percentage of treatment-emergent marked abnormalities in chemistry parameters [ Time Frame: During the study (up to 5 years) ]
  4. Percentage of treatment-emergent marked abnormalities in 12-lead electrocardiogram (ECGs) [ Time Frame: During the study (up to 5 years) ]
  5. Percentage of treatment-emergent marked abnormalities in vital sign measurements [ Time Frame: During the study (up to 5 years) ]


Information from the National Library of Medicine

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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). 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.


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


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Sponsors and Collaborators
UCB BIOSCIENCES, Inc.
Investigators
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Study Director: UCB Cares +18445992273 (UCB)

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Responsible Party: UCB BIOSCIENCES, Inc.
ClinicalTrials.gov Identifier: NCT02408549     History of Changes
Other Study ID Numbers: EP0012
2012-001770-29 ( EudraCT Number )
First Posted: April 3, 2015    Key Record Dates
Last Update Posted: June 24, 2019
Last Verified: June 2019

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
Epilepsy, Generalized
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Lacosamide
Anticonvulsants
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action