Ensayos clínicos

Inclusion Criteria

• Male and female 
• Between 6 and 65 years
• Written informed consent to participate in the study
• Has a clinical diagnosis of Epilepsy 
• Continues to experience bouts of seizures while on a stable regimen of anti-epileptic medication (has frequent break through seizures or Acute Repetitive Seizures) and  in the opinion of the Investigator may need benzodiazepine intervention for seizure control at least 1 time a month on average
• Has a qualified caregiver or medical professional available that can administer study medication in the event of a seizure
• Is having either partial or generalized Epilepsy with motor seizures or seizures with clear alteration of awareness
• Female subjects of childbearing potential, defined as having a menstrual cycle and who are not surgically sterile or less than two (2) years postmenopausal, must complete a pregnancy screen and agree to utilize one of the following forms of contraception during the trial and for 21 days after the last dose of study drug
  • Abstinence
  • Hormonal (oral, transdermal, implant, or injection)
  • Barrier (condom, diaphragm with spermicide)
  • Intrauterine device (IUD)
  • Vasectomized partner (six months minimum)
• No clinically significant abnormal findings in the medical history, on the physical examination or electrocardiogram (QTcF<450 msec for males and QTcF<470 msec for females)
• Must agree to return to the study site for all study visits and must be willing to comply with all required study procedures

Exclusion Criteria

• A history of clinically significant gastrointestinal, renal, hepatic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease, or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject
• Has had significant traumatic injury, major surgery or open biopsy within 30 days prior to study screening
• Has history of major depression or a past suicide attempt, any suicidal ideation, any suicidal behavior in lifetime using Columbia-Suicide Severity Rating Scale (C-SSRS)
  • The pediatric C-SSRS should be used for subjects age 6 to 11
  • The adult C SSRS should be used for subjects 12 and greater years of age
• A history of allergic or adverse responses to diazepam or any comparable or similar product
• Participation in a clinical trial other than protocol DIAZ.001.04 within 30 days prior to day 0
  • Participation in an observational (non-interventional) study is not excluded as long as there are no scheduling conflicts with this study
• Positive serum pregnancy test (ß-hCG) at screening
• Positive blood screen for Human immunodeficiency virus (HIV), Hepatitis B surface antigen (HbSAg), Hepatitis C, or a positive urine screen for alcohol, drugs of abuse, or nicotinine