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A Study to Assess the Safety and Efficacy of Lacosamide Versus Placebo (a Pill Without Active Medication) in Patients With Idiopathic Generalised Epilepsy Who Are Already Taking Anti-epileptic Medications (VALOR)

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ClinicalTrials.gov Identifier: NCT02408523
Recruitment Status : Recruiting
First Posted : April 3, 2015
Last Update Posted : September 14, 2018
Sponsor:
Collaborator:
Pharmaceutical Research Associates
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES, Inc. )

Brief Summary:
Evaluating efficacy & safety of lacosamide versus Placebo in a blinded fashion as add-on Therapy for Primary Generalized Tonic-clonic (PGTC) seizures in subject 4 years of age or greater with idiopathic generalized epilepsy currently taking 1 to 3 antiepileptic drugs. Maximum duration of study drug administration is 28 weeks. Eligible subjects may choose to enter the open-label extension study after completion.

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

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized, Placebo-controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Lacosamide as Adjunctive Therapy for Uncontrolled Primary Generalized Tonic-Clonic Seizures in Subjects With Idiopathic Generalized Epilepsy
Actual Study Start Date : April 2015
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: Lacosamide

Lacosamide 50 mg tablets: starting with 100 mg/day at Week 1. Weekly increase in steps of 50 mg or 100 mg/day are allowed. Maximal dose 400 mg/day for adult subjects and pediatric subjects >= 50 kg.

Lacosamide oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 12 mg/kg/day for pediatric subjects < 30 kg.)

Lasosamide oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 8 mg/kg/day for pediatric subjects 30 kg to < 50 kg.)

Drug: Lacosamide Tablet
  • Active Substance: Lacosamide
  • Pharmaceutical Form: Film-coated Tablet
  • Concentration: 50 mg
  • Route of Administration: Oral use
Other Name: Vimpat

Drug: Lasosamide Oral Solution
  • Active Substance: Lacosamide
  • Pharmaceutical Form: Oral Solution
  • Concentration: 10 mg/ml
  • Route of Administration: Oral use
Other Name: Vimpat

Placebo Comparator: Placebo

Placebo 50 mg tablets: starting with 100 mg/day at Week 1. Weekly increase in steps of 50 mg or 100 mg/day are allowed. Maximal dose 400mg/day for adult subjects and pediatric subjects >= 50kg.

Placebo oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 12 mg/kg/day for pediatric subjects < 30kg.)

Placebo oral solution 10 mg/ml: starting with 2 mg/kg/day, titrations steps (1 mg/kg/day to 2 mg/kg/day; maximal dose 8 mg/kg/day for pediatric subjects 30kg to < 50kg.)

Other: Placebo Tablet
  • Active Substance: Placebo
  • Pharmaceutical Form: Film-coated Tablet
  • Concentration: 50 mg
  • Route of Administration: Oral use

Other: Placebo Oral Solution
  • Active Substance: Placebo
  • Pharmaceutical Form: Oral Solution
  • Concentration: 10 mg/ml
  • Route of Administration: Oral use




Primary Outcome Measures :
  1. Time to the second primary generalized tonic clonic (PGTC) seizure during the 24-week Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24) [ Time Frame: 24-week Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24) ]
    Time to the second primary generalized tonic clonic (PGTC) seizure during the 24-week Treatment Period.


Secondary Outcome Measures :
  1. Seizure freedom for primary generalized tonic clonic (PGTC) seizures during the 24-week Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24) [ Time Frame: 24-week Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24) ]
    Seizure freedom for PGTC seizures for the 24-week Treatment Period

  2. Time to the first primary generalized tonic clonic (PGTC) seizure during the Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24) [ Time Frame: During the Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24) ]
    Time to the first PGTC seizure during the 24-week Treatment Period.

  3. Incidence of Treatment Emergent Adverse Events (TEAEs) as reported spontaneously by the subject and/or caregiver or observed by the investigator [ Time Frame: From Visit 1 (Week -4) to End of Study Period (up to Week 36) ]
    An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. A Treatment Emergent Adverse Event (TEAE) is any event that emerges during treatment having been absent pre-treatment, or worsens relative to the pre-treatment state.

  4. Incidence of Serious Adverse Events (SAEs) as reported spontaneously by the subject and/or caregiver or observed by the investigator [ Time Frame: From Visit 1 (Week -4) to End of Study Period (up to Week 36) ]

    A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:

    • Results in death
    • Is life-threatening
    • Requires in patient hospitalization or prolongation of existing hospitalization
    • Is a congenital anomaly or birth defect
    • Is as infection that requires treatment parenteral antibiotics
    • Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above



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 with a confirmed diagnosis at least 24 weeks prior to Visit 1 and a disease onset prior to 30 years of age, consistent with idiopathic generalized epilepsy (IGE) experiencing primary generalizedtonic-clonic (PGTC) seizures (Type IIE) that are classifiable according to the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures (ILAE, 1981)
  • Subject has >=3 PGTC seizures during the 16-week Combined Baseline (12-week Historical Baseline plus 4-week Prospective Baseline)
  • If a brain magnetic resonance imaging (MRI)/computed tomography (CT) scan has been performed, there must be no evidence of any progressive abnormality or any lesion likely to be associated with partial-onset seizures
  • Subject has been maintained on a stable dose regimen of 1 to 2 non-benzodiazepine marketed antiepileptic drugs (AEDs) with no benzodiazepine AEDs OR 1 benzodiazepine marketed AED with 1 to 2 non benzodiazepine marketed AEDs for at least 28 days prior to Visit 1 with or without additional concurrent stable vagus nerve stimulation (VNS)
  • Subjects are required to have had an electroencephalogram (EEG) report consistent with idiopathic generalized epilepsy (eg, generalized 3Hz epileptiform discharges and a normal EEG background) confirmed by a Central Reviewer

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 electronic case report form (eCRF).

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): NCT02408523


Contacts
Contact: UCB Cares +1844599 ext 2273 UCBCares@ucb.com

  Show 196 Study Locations
Sponsors and Collaborators
UCB BIOSCIENCES, Inc.
Pharmaceutical Research Associates
Investigators
Study Director: UCB Cares +1 844 599 2273 (UCB)

Responsible Party: UCB BIOSCIENCES, Inc.
ClinicalTrials.gov Identifier: NCT02408523     History of Changes
Other Study ID Numbers: SP0982
2011-003100-21 ( EudraCT Number )
First Posted: April 3, 2015    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018

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:
Anticonvulsants
Epilepsy
Seizures
Epilepsy, Generalized
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Pharmaceutical Solutions
Lacosamide