Trial · NCT01494584
Outcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 26
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) Following Oral Administration of Ezogabine/Retigabine | Pre-dose and 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 | Pharmacokinetic Population: all participants in the All Subjects Population (defined as all participants who received at least one dose of study medication) for whom a pharmacokinetic sample was obtained and analyzed | Hour*Nanograms/Milliliter (h.ng/mL) | GEOMETRIC_MEAN |
| PRIMARY | Apparent Clearance (CL/F) Following Oral Administration of Ezogabine/Retigabine | Pre-dose and 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 | Pharmacokinetic Population | Liters/Hour | GEOMETRIC_MEAN |
| PRIMARY | Maximum Observed Concentration (Cmax) and Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) Following Oral Administration of Ezogabine/Retigabine | Pre-dose and 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 | Pharmacokinetic Population | Nanograms/Milliliter (ng/mL) | GEOMETRIC_MEAN |
| PRIMARY | Apparent Volume of Distribution (Vd/F) Following Oral Administration of Ezogabine/Retigabine | Pre-dose and 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 | Pharmacokinetic Population. Only those participants available at the specified time points were analyzed. | Liters | GEOMETRIC_MEAN |
| SECONDARY | Number of Participants With Any Adverse Event (AE) | From the start of the first titration until follow-up (assessed up to 46 days) | All Subjects Population: all participants who received at least one dose of study medication | Participants | NUMBER |
| SECONDARY | Change From Baseline in Albumin and Total Protein at Day 7 Post Each Up-titration | Baseline (Screening), Day 7, Day 21, and Day 35 | All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population. | Grams per Liter (G/L) | MEAN |
| SECONDARY | Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, and Gamma Glutamyl Transferase at Day 7 Post Each Up-titration | Baseline (Screening), Day 7, Day 21, and Day 35 | All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population. | International Units per Liter (IU/L) | MEAN |
| SECONDARY | Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine, and Uric Acid at Day 7 Post Each Up-titration | Baseline (Screening), Day 7, Day 21, and Day 35 | All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population. | Micromoles per liter (UMOL/L) | MEAN |
| SECONDARY | Change From Baseline in Calcium, Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (BUN) at Day 7 Post Each Up-titration | Baseline (Screening), Day 7, Day 21, and Day 35 | All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population. | Millimoles per liter (MMOL/L) | MEAN |
| SECONDARY | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total ANC [Total Absolute Neutrophil Count]), Platelet Count, and White Blood Cell Count at Day 7 Post Each Up-titration | Baseline (Screening), Day 7, Day 21, and Day 35 | All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population. | Giga (10^9) cells per liter (GI/L) | MEAN |
| SECONDARY | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration at Day 7 Post Each Up-titration | Baseline (Screening), Day 7, Day 21, and Day 35 | All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population. | Grams per liter (G/L) | MEAN |
| SECONDARY | Change From Baseline in Hematocrit at Day 7 Post Each Up-titration | Baseline (Screening), Day 7, Day 21, and Day 35 | All Subjects Population. Only those participants available at the specified time point were analyzed. | Fraction of one unit (1) | MEAN |
| SECONDARY | Change From Baseline in Mean Corpuscle Hemoglobin at Day 7 Post Each Up-titration | Baseline (Screening), Day 7, Day 21, and Day 35 | All Subjects Population. Only those participants available at the specified time point were analyzed. | Picograms (PG) per cell (PG/cell) | MEAN |
| SECONDARY | Change From Baseline in Mean Corpuscle Volume at Day 7 Post Each Up-titration | Baseline (Screening), Day 7, Day 21, and Day 35 | All Subjects Population. Only those participants available at the specified time point were analyzed. | Femtoliters (FL) | MEAN |
| SECONDARY | Change From Baseline in Red Blood Cell Count at Day 7 Post Each Up-titration | Baseline (Screening), Day 7, Day 21, and Day 35 | All Subjects Population. Only those participants available at the specified time point were analyzed. | 10^12 cells/L (TI/L) | MEAN |
| SECONDARY | Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up | Screening, Day 1 (D1), Day 7 (D7), Day 14 (D14), Day 21 (D21), Day 28 (D28), Day 35 (D35), and at the Follow-up Visit (up to Day 46) | All Subjects Population (ASP). Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X in the category titles). Different participants may have been analyzed at different time points and for different parameters, so the overall number of participants analyzed reflects everyone in the ASP. | Participants | NUMBER |
| SECONDARY | Percent Change From Baseline in 28-day Seizure Frequency Rate | Baseline (Screening) and until Follow-up or early discontinuation (assessed up to 46 days) | All Subjects Population. Only participants with baseline and post-baseline seizure measurements were included in the analysis. | Percent change | MEAN |
| SECONDARY | Area Under the Concentration-time Curve From Time Zero (Pre-dose) to the Last Time of Quantifiable Concentration (AUC [0-t]) for the N-acetyl Metabolite of Ezogabine/Retigabine | Pre-dose and 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 | PK Population | h*ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) for the N-acetyl Metabolite of Ezogabine/Retigabine | Pre-dose and 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 | PK Population | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Time to Maximum Concentration (Tmax) Following Oral Administration of Ezogabine/Retigabine | Pre-dose and 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 | PK Population | Hours | MEDIAN |
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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