Trial · NCT01494584
Study in Pediatric Subjects With Epilepsy
NCT01494584, Phase 2, Terminated, GlaxoSmithKline; results first posted 2014-09-04
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ConductScience Library. Study in Pediatric Subjects With Epilepsy. Trials, record NCT01494584. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01494584
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study in Pediatric Subjects With Epilepsy
- NCT number
- NCT01494584
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 5 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Epilepsy
- Interventions
- ezogabine/retigabine
- First posted
- 2011-12-19
- Last updated
- 2020-11-30
- Results first posted
- 2014-09-04
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | The steady state pharmacokinetic profile following oral administration of ezogabine/retigabine included determining the area under the curve over the dosing interval (AUC\[0-tau\]). The area under the plasma concentration-time curve over the dosing interval (AUC\[0-tau\]) was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. Blood samples were collected at pre-dose and at 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 to estimate AUC(0-tau). |
| 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 | Clearance (CL/F) is defined as dose/AUC(0-tau). Blood samples were collected at pre-dose and at 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 to estimate CL/F. |
| 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 | Cmax is defined as the first occurrence of the maximum observed plasma concentration. Ctau refers to the pre-dose (trough) concentration after the dosing interval which is equal to the minimum observed concentration (Cmin) at Steady State. Blood samples were collected at pre-dose and at 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 to estimate Cmax and Ctau. |
| 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 | The volume of distribution (Vd/F) is defined as MRT\*CL/F, where MRT is the mean residence time (calculated as AUMC\[0-tau\]/AUC\[0-tau\], where AUMC\[0-tau\] is the area under the first moment curve determined as the area under the concentration\*time versus time curve). Blood samples were collected at pre-dose and at 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 to estimate the apparent volume of distribution. |
| Secondary | Number of Participants With Any Adverse Event (AE) | From the start of the first titration until follow-up (assessed up to 46 days) | An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. |
| 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 | Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit. |
| 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 | Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit. |
| 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 | Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit. |
| 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 | Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit. |
| 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 | Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit. |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 registered outcomesOutcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 outcomesResults by group824
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) Following Oral Administration of Ezogabine/Retigabine | Regimen A: Ezogabine/Retigabine (E/R) 300 mg | 1680.0 | 95% Confidence Interval 1162.4 to 2428.2 | Hour*Nanograms/Milliliter (h.ng/mL) | |
| The Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) Following Oral Administration of Ezogabine/Retigabine | Regimen A: E/R 300/450 mg Then 600 mg | 2558.8 | 95% Confidence Interval 1873.4 to 3494.8 | Hour*Nanograms/Milliliter (h.ng/mL) | |
| The Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) Following Oral Administration of Ezogabine/Retigabine | Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | 3783.8 | 95% Confidence Interval 1059.6 to 13512.0 | Hour*Nanograms/Milliliter (h.ng/mL) | |
| Apparent Clearance (CL/F) Following Oral Administration of Ezogabine/Retigabine | Regimen A: Ezogabine/Retigabine (E/R) 300 mg | 178.6 | 95% Confidence Interval 123.5 to 258.1 | Liters/Hour | |
| Apparent Clearance (CL/F) Following Oral Administration of Ezogabine/Retigabine | Regimen A: E/R 300/450 mg Then 600 mg | 234.5 | 95% Confidence Interval 171.7 to 320.3 | Liters/Hour | |
| Apparent Clearance (CL/F) Following Oral Administration of Ezogabine/Retigabine | Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | 237.9 | 95% Confidence Interval 66.6 to 849.4 | Liters/Hour | |
| Maximum Observed Concentration (Cmax) and Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) Following Oral Administration of Ezogabine/Retigabine | Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Cmax | 370.0 | 95% Confidence Interval 260.9 to 524.7 | Nanograms/Milliliter (ng/mL) |
| Maximum Observed Concentration (Cmax) and Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) Following Oral Administration of Ezogabine/Retigabine | Regimen A: E/R 300/450 mg Then 600 mg | Cmax | 535.9 | 95% Confidence Interval 344.4 to 833.8 | Nanograms/Milliliter (ng/mL) |
| Maximum Observed Concentration (Cmax) and Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) Following Oral Administration of Ezogabine/Retigabine | Regimen A: E/R 300/450/ 600/750 mg Then 900 mg | Cmax | 750.9 | 95% Confidence Interval 289.8 to 1945.3 | Nanograms/Milliliter (ng/mL) |
| Maximum Observed Concentration (Cmax) and Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) Following Oral Administration of Ezogabine/Retigabine | Regimen A: Ezogabine/Retigabine (E/R) 300 mg | Ctau | 105.32 | 95% Confidence Interval 58.70 to 188.98 | Nanograms/Milliliter (ng/mL) |
1 to 10 of 824Source ClinicalTrials.gov
See all 824 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ezogabine/Retigabine | 5 | |
| Overall Study | COMPLETED | Ezogabine/Retigabine | 4 | |
| Overall Study | NOT COMPLETED | Ezogabine/Retigabine | 1 |
Source ClinicalTrials.gov
Adverse events15
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Regimen A: Ezogabine/Retigabine 300 mg | 1 | 5 | |
| other | Diarrhoea | Gastrointestinal disorders | Regimen A: Ezogabine/Retigabine 300 mg, Then 450 mg | 0 | 5 | |
| other | Diarrhoea | Gastrointestinal disorders | Regimen A: Ezogabine/Retigabine 300/450 mg, Then 600 mg | 0 | 4 | |
| other | Diarrhoea | Gastrointestinal disorders | Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | 0 | 4 | |
| other | Diarrhoea | Gastrointestinal disorders | Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | 0 | 3 | |
| other | Somnolence | Nervous system disorders | Regimen A: Ezogabine/Retigabine 300 mg | 0 | 5 | |
| other | Somnolence | Nervous system disorders | Regimen A: Ezogabine/Retigabine 300 mg, Then 450 mg | 0 | 5 | |
| other | Somnolence | Nervous system disorders | Regimen A: Ezogabine/Retigabine 300/450 mg, Then 600 mg | 1 | 4 | |
| other | Somnolence | Nervous system disorders | Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | 0 | 4 | |
| other | Somnolence | Nervous system disorders | Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | 0 | 3 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Regimen A: Ezogabine/Retigabine 300 mg | ||
| Total, all-cause mortality | Regimen A: Ezogabine/Retigabine 300 mg, Then 450 mg | ||
| Total, all-cause mortality | Regimen A: Ezogabine/Retigabine 300/450 mg, Then 600 mg | ||
| Total, all-cause mortality | Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | ||
| Total, all-cause mortality | Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | ||
| Total, other adverse events | Regimen A: Ezogabine/Retigabine 300 mg | 1 | 5 |
| Total, other adverse events | Regimen A: Ezogabine/Retigabine 300 mg, Then 450 mg | 1 | 5 |
| Total, other adverse events | Regimen A: Ezogabine/Retigabine 300/450 mg, Then 600 mg | 1 | 4 |
| Total, other adverse events | Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg | 0 | 4 |
| Total, other adverse events | Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg | 0 | 3 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27877093 | BACKGROUND |
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.
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