Trial · NCT03780907
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| 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. |
| Secondary | 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. |
| Secondary | Number of Particpants receiving other Anti-epileptic agents During Treatment | Day 1 and Day 14 | |
| Secondary | 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. |
| Secondary | Mean trough concentrations of E2007 | Day 7, Day 21, and Day 28 | |
| Secondary | Number of seizures | Baseline (Day-1) to Day 42 | |
| Secondary | The Clinical Global Impression of Change | Day 28 |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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