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Trial record 2 of 2 for:    SP0982

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)

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by UCB Pharma ( UCB BIOSCIENCES, Inc. )
Sponsor:
Collaborator:
Pharmaceutical Research Associates
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES, Inc. )
ClinicalTrials.gov Identifier:
NCT02408523
First received: March 31, 2015
Last updated: June 7, 2017
Last verified: June 2017
  Purpose
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 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 Intervention Phase
Epilepsy Drug: Lacosamide Tablet Drug: Lasosamide Oral Solution Other: Placebo Tablet Other: Placebo Oral Solution Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by UCB Pharma ( UCB BIOSCIENCES, Inc. ):

Primary Outcome Measures:
  • 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:
  • 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

  • The percent change in primary generalized tonic clonic (PGTC) seizure frequency per 28 days during the first 6 weeks of the Treatment Period (Titration Phase) relative to the Combined Baseline (combined 12-week Historical and 4-week Prospective Baseline) [ Time Frame: During the first 6 weeks of the Treatment Period (Titration Phase) relative to the Combined Baseline (combined 12-week Historical and 4-week Prospective Baseline) ]
    The percent change in PGTC seizure frequency per 28 days from the Combined Baseline (combined 12-week Historical and 4-week Prospective Baseline) to the first 6 weeks of the Treatment Period.

  • The percent change in primary generalized tonic clonic (PGTC) seizure frequency per 28 days during the Treatment Period relative to the Combined Baseline (combined 12-week Historical and 4-week Prospective Baseline) [ Time Frame: During the Treatment Period relative to the Combined Baseline (combined 12-week Historical and 4-week Prospective Baseline) ]
    The percent change in PGTC seizure frequency per 28 days from the Combined Baseline (combined 12-week Historical and 4-week Prospective Baseline) to the 24-week Treatment Period.

  • 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.


Estimated Enrollment: 200
Study Start Date: April 2015
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   4 Years and older   (Child, Adult, Senior)
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) OR 1 to 3 AEDs (with 1 AED identified as a benzodiazepine) 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 IGE (eg, generalized 3Hz epileptiform discharges and a normal EEG background) confirmed by a Central Reviewer

Exclusion Criteria:

  • History of partial onset seizures or EEG findings indicating partial onset seizures
  • Symptomatic generalized epilepsy, e.g. Lennox-Gastaut Syndrome
  • Lifetime history of suicide attempt, or suicidal ideation in past 6 months
  • Women of child bearing potential must practice contraception according to protocol requirements
  • Regular use of clozapine, monoamine oxidase (MAO-A) inhibitors, barbiturates (for indication other than epilepsy) within 28 days prior to Visit 1
  • Use of Vigabatrin within the last 6 months
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02408523

Contacts
Contact: UCB Cares +1 844 599 ext 2273 UCBCares@ucb.com

  Show 170 Study Locations
Sponsors and Collaborators
UCB BIOSCIENCES, Inc.
Pharmaceutical Research Associates
Investigators
Study Director: UCB Cares +1 844 599 2273 (UCB)
  More Information

Responsible Party: UCB BIOSCIENCES, Inc.
ClinicalTrials.gov Identifier: NCT02408523     History of Changes
Other Study ID Numbers: SP0982
Study First Received: March 31, 2015
Last Updated: June 7, 2017

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

ClinicalTrials.gov processed this record on July 21, 2017