Trial · NCT03780907
Safety and Pharmacokinetics Study of E2007 to Treat Partial and Generalised Seizures in People With Epilepsy
NCT03780907, Phase 2, Completed, Eisai Co., Ltd.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Pharmacokinetics Study of E2007 to Treat Partial and Generalised Seizures in People With Epilepsy. Trials, record NCT03780907. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03780907
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Pharmacokinetics Study of E2007 to Treat Partial and Generalised Seizures in People With Epilepsy
- NCT number
- NCT03780907
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 18 participants, actual
- Lead sponsor
- Eisai Co., Ltd.
- Conditions
- Epilepsy
- Interventions
- E2007, E2007, Placebo
- First posted
- 2018-12-19
- Last updated
- 2018-12-19
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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'. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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). |
| Primary | 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. |
| Primary | Pharmacokinetic Parameter: Cav (Average Plasma Concentration) of E2007 | Day 14 | Standard pharmacokinetic parameters for E2007 were derived from plasma drug concentrations in epileptic participants. |
| Primary | 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. |
| Primary | Pharmacokinetic Parameter: Observed Accumulation Ratio (Rac) of E2007 | Day 14 | Standard pharmacokinetic parameters for E2007 were derived from plasma drug concentrations in epileptic participants. |
| Secondary | 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. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35305920 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03780907
GET https://conductscience.org/api/trials/v1/NCT03780907/registered