Health Condition 1: G409- Epilepsy, unspecified
Conditions
Interventions
Intervention1: Levetiracetam: Prolonged-release granules in sachet,
1000 mg per day, once a day dose (1000 mg per sachet)
Control Intervention1: Placebos: Coated granules in sachet, once a day dose.
Sponsors
Neuraxpharm Pharmaceuticals S.L.
Neuraxpharm Pharmaceuticals SL
Eligibility
Inclusion criteria
Inclusion criteria: 1) Male and female, between 18 and above years of age, both inclusive. 2) Willingness and capability to provide informed consent form (ICF), be compliant with study procedures such as eDiary completion, be compliant with background anti-seizure medication (ASM) and Investigational Medicinal Product (IMP) intake. 3) Diagnosis of epilepsy with Focal-onset seizures (FOS) with or without secondary generalization according to the International League Against Epilepsy Classification of epileptic seizures. 4) On stable doses of ASM for at least 4 weeks prior to screening. 5) Confirmed drug-resistant FOS despite 1 to 3 stable ASM with at least 6 seizures during the 8 week observational period. 6) Patients who have Vagal Nerve Stimulator (VNS) must have stable settings more than 3 months prior to screening and expected to remain unchanged during the duration of the study. 7) Females of childbearing potential, if not abstinent, should use a highly effective double contraception, started 60 days prior to study entry and 30 days after end of study drug administration: a) Oral, injected or implanted hormonal methods of contraception. b) Intrauterine device (IUD) c) Barrier methods: condom, diaphragm, spermicidal foam d) Male partner surgical sterilization (vasectomy) 8) Females of non-childbearing potential: either surgically sterilized (e.g. bilateral tubal ligation), had undergone hysterectomy or is at least 1 year postmenopausal (amenorrhea duration of at least 12 months) 9) Sexually active males with partner of childbearing potential commit to use an acceptable method of birth control consistently and correctly (oral, transdermal, systemic or implant contraception birth control, intrauterine devices) for 90 days after the last study drug administration.
Exclusion criteria
Exclusion criteria: 1) Presence of primary generalized epilepsies or seizures, such as absences, myoclonic epilepsies, Lennox Gastaut syndrome. 2) History of status epilepticus in the past 3 months prior to screening. 3) Seizure clusters where individual seizures cannot be counted. 4) History of non epileptic seizures. 5) Evidence of clinically significant disease (cardiac, respiratory, gastrointestinal, hepatic, hematologic or renal disease, neoplastic malignancies etc.) that in the opinion of the investigator could affect the subjects safety or trial conduct. 6) Neurodegenerative and other progressive neurological disorders. 7) Diagnosis of active psychiatric disease, except depressed subjects on stable doses of selective serotonin reuptake inhibitors or serotonin and norepinephrine reuptake inhibitors for at least 12 weeks prior to screening. 8) History of prior suicide attempt or imminent risk of self harm based on investigators judgment or with a yes answer on item 4 or 5 on the Columbia Suicide Severity Rating Scale (CSSRS). 9) History of drug abuse as defined by Diagnostic and Statistical Manual of Mental Disorders version 5 (DSM V) and or positive drug screening other than prescribed drugs. 10) Alcohol abuse as per Diagnostic and Statistical Manual of Mental Disorders version 5 (DSM V) in the past year. 11) Positive for hepatitis C virus (HCV) or hepatitis B surface antigen (HBsAg) or Human Immunodeficiency Virus (HIV) infection at screening. 12) Subjects presenting symptoms of coronavirus disease COVID 19. 13) Known allergic reaction or intolerance to levetiracetam or other pyrrolidone derivatives or to any of the excipients. 14) Participation in a study involving administration of an investigational product within one month prior to screening or within five half lives of the previous study investigational compound, whichever is longer. 15) Women who are currently pregnant, who intend to become pregnant during the study, or who are breastfeeding. 16) Subjects with a diagnosis of Congenital Short QT Syndrome (SQTS). Subjects with a family history of Congenital Short QT Syndrome (SQTS) or family history of sudden death of unknown cause. 17) The corrected QT interval by Fredericia (QTcF) more than and equal 450 msec in male and 470 msec in female subjects. 18) Laboratory values at screening: Platelets less than 100,000 per mm3 Absolute neutrophil count less than 1500 per mm3 Haemoglobin within 10.0g per dL Aspartate aminotransferase or alanine aminotransferase more than 3x upper limit of normal Estimated Glomerular Filtration Rate less than 80
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess the reduction in weekly Focal Onset Seizures (FOS) frequency of levetiracetam extended release (XR) compared to levetiracetam immediate release (IR) in subjects with drug resistant FOSTimepoint: Assess the reduction in Focal Onset Seizures (FOS) frequency in 8 Weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| assess the reduction in weekly FOS frequency of levetiracetam XR compared to placebo in subjects with drug-resistant FOS.Timepoint: Change from baseline in absolute FOS over the 12 week double blind period. Proportion of subjects with at least 50 percentage reduction from baseline in total seizure frequency per week over the 12 week double blind period. Proportion of subjects with at least 50% reduction from baseline in total seizures over the 12 week double blind period | — |
Countries
Bosnia and Herzegovina, Bulgaria, Czech Republic, France, Georgia, Germany, Hungary, India, Italy, Poland, Romania, Serbia, Spain
Contacts
Public ContactKoushik Ganguly
ERGOMED Clinical Research India Pvt Ltd
Outcome results
None listed