Safety and Pharmacokinetics Study of E2007 to Treat Partial and Generalised Seizures in People With Epilepsy
- Registration Number
- NCT03780907
- Lead Sponsor
- Eisai Co., Ltd.
- Brief Summary
The objectives of this study were to assess the tolerability and safety of E2007 in patients with refractory partial or generalised seizures and to assess the pharmacokinetics of E2007 in epileptic patients receiving at least one concomitant anti-epileptic drug.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description E2007 1 mg E2007 Tablet, once daily to be taken in the morning by mouth, one hour before breakfast, with a glass of water. E2007 2 mg E2007 Tablet, once daily to be taken in the morning by mouth, one hour before breakfast, with a glass of water. Placebo Placebo Tablet, once daily to be taken in the morning, one hour before breakfast, with a glass of water.
- Primary Outcome Measures
Name Time Method Clinical Global Impression of Tolerability (CGIT) Day 28 The investigator's global impressions of the tolerability of the study treatment was based on a five point scale: 1 - very good, 2 - good, 3 - moderate, 4 - poor, and 5 - very poor.
Pharmacokinetic Parameter: Area Under the Curve (AUC)(0-24hr) of E2007 Day 1 and Day 14 Standard pharmacokinetic parameters for E2007 were derived from plasma drug concentrations in epileptic participants. A measure of systemic drug exposure over 24 hours, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.
Number of participants with Treatment Emergent Adverse Events (TEAEs) From administration of first dose of study drug up until 42 days. The TEAEs were defined as those Adverse Events (AEs) that start on or after the first dose of the treatment until the end of the study. AEs were classified by the investigator as 'not related', 'possibly related' or 'probably related'.
Pharmacokinetic Parameter: Cmax (Maximum Observed Plasma Concentration) of E2007 Day 1 and Day 14 Standard pharmacokinetic parameters for E2007 were derived from plasma drug concentrations in epileptic participants. The maximum concentration of a drug observed after its administration.
Pharmacokinetic Parameter: Tmax (Time to Maximum Concentration) of E2007 Day 1 and Day 14 Standard pharmacokinetic parameters for E2007 were derived from plasma drug concentrations in epileptic participants. The time after dosing when a drug attains its highest measurable concentration (Cmax).
Pharmacokinetic Parameter: Css,min (Minimum Steady State Plasma Concentration) of E2007 Day 14 Standard pharmacokinetic parameters for E2007 were derived from plasma drug concentrations in epileptic participants. Lowest plasma concentration within a steady-state dosing interval.
Pharmacokinetic Parameter: Cav (Average Plasma Concentration) of E2007 Day 14 Standard pharmacokinetic parameters for E2007 were derived from plasma drug concentrations in epileptic participants.
Pharmacokinetic Parameter: Observed Accumulation Ratio (Rac) of E2007 Day 14 Standard pharmacokinetic parameters for E2007 were derived from plasma drug concentrations in epileptic participants.
Pharmacokinetic Parameter: Peak-to-trough Fluctuation (PTF) of E2007 Day 14 Standard pharmacokinetic parameters for E2007 were derived from plasma drug concentrations in epileptic participants.
- Secondary Outcome Measures
Name Time Method Change from Baseline of Bond and Lader Scale Baseline, Day 28 and Day 42 The Bond and Lader visual analogue mood scale (VAMS) had a score from 0 - 100; a higher score represented worsening of the participants condition attributed to 3 factors, (1) Anxiety (e.g., calmness), (2) Sedation (e.g., alertness, (3) Dysphoria (e.g., contentedness). The change was visit minus baseline.
Change from Baseline of Peak Saccadic Velocity (PSV) Baseline, Day 28, Day 42 Saccadic velocity is the rate of eye movement in response to stimulus. The saccadic eye movement was used to allow comparison of any sedative effects seen.
Percent Change from Baseline of Failed Saccades Baseline, Day 28, Day 42 Failed saccades is stimulus resulting in no eye movement above a defined threshold within a specified time.
Number of Particpants receiving other Anti-epileptic agents During Treatment Day 1 and Day 14 Mean trough concentrations of E2007 Day 7, Day 21, and Day 28 Number of seizures Baseline (Day-1) to Day 42 The Clinical Global Impression of Change Day 28
Trial Locations
- Locations (1)
3ClinicalResearch AG
🇩🇪Hennigsdorf, Germany