Epilepsy
Conditions
Keywords
Epilepsy, E2007, partial seizures, generalized seizures
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.
Interventions
DRUGE2007
1 mg of E2007 was administered by mouth once daily.
DRUGPlacebo
Placebo once daily of oral tablet formulation to be taken in the morning, one hour before breakfast, with a glass of water.
Sponsors
Eisai Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
A patient who met the following inclusion criteria was eligible to participate in the study: 1. Males or females with simple or complex partial seizures with or without secondary generalization, or primary generalized tonic-clonic seizures according to the International League against Epilepsy classification. Patient records were to document the frequency of seizure. 2. Age: 18 to 65 years. 3. Race: any. 4. Patients receiving up to two additional anti-epileptic medications at doses that were stable for at least the four weeks immediately preceding baseline. 5. Patients willing and able to co-operate with the study procedures including completion of patient diaries. 6. Patients living at home with a partner or carer able to monitor compliance. 7. Patients giving informed consent to participate in the study.
Exclusion criteria
A patient who met the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic Parameter: Observed Accumulation Ratio (Rac) of E2007 | Day 14 | Standard pharmacokinetic parameters for E2007 were derived from plasma drug concentrations in epileptic participants. |
| 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. |
| 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: Peak-to-trough Fluctuation (PTF) of E2007 | Day 14 | Standard pharmacokinetic parameters for E2007 were derived from plasma drug concentrations in epileptic participants. |
| 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'. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Number of Particpants receiving other Anti-epileptic agents During Treatment | Day 1 and Day 14 | — |
| 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. |
| 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 | — |
| 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. |
Countries
Germany
Outcome results
None listed