Trial · NCT01668654
Long-term, Open-label Safety Extension Study of Retigabine/Ezogabine in Pediatric Subjects (>= 12 Years Old) With POS or LGS
NCT01668654, Phase 3, Terminated, GlaxoSmithKline; results first posted 2014-08-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Long-term, Open-label Safety Extension Study of Retigabine/Ezogabine in Pediatric Subjects (>= 12 Years Old) With POS or LGS. Trials, record NCT01668654. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01668654
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-term, Open-label Safety Extension Study of Retigabine/Ezogabine in Pediatric Subjects (>= 12 Years Old) With POS or LGS
- NCT number
- NCT01668654
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 4 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Epilepsy
- Interventions
- retigabine/ezogabine
- First posted
- 2012-08-20
- Last updated
- 2020-10-30
- Results first posted
- 2014-08-04
- Limitations and caveats
This study was terminated early and only 4 of the planned 500 participants were enrolled. Due to the early study termination and small sample size, many planned analyses were not completed therefore lmiited results data were available.
Source ClinicalTrials.gov
Registered outcomes37
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants (Par.) With Any Adverse Event (AE) or Serious Adverse Event (SAE) During the Treatment Period | From the start of study medication until the end of Follow-Up (up to 178 days) | An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of the study medication, whether or not considered related to the study medication. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations. Please refer to the AE/SAE module for a list of non-serious AEs and SAE. |
| Primary | Number of Participants With AEs Leading to Withdrawal | From the start of study medication until the end of the Follow-Up Visit (up to 178 days) | An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of the study medication, whether or not considered related to the study medication. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations. Please refer to the AE/SAE module for a list of non-serious AEs and SAE. |
| Primary | Number of Participants With Vital Signs Outside the Pre-determined Clinically Important Findings or Outside the Normal Ranges at Any Time During the Study | Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days) | Vital sign assessment included systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate and body temperature measurements. SBP, DBP and heart rate were measured at the following Visits: 1, 4, 5, 6, 7, EW and the FU Visit after the participants were in the seated position for 5 minutes. |
| Primary | Change From Baseline in SBP and DBP at the Indicated Time Points | Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days) | Vital sign assessment included SBP and DBP measurements. SBP and DBP were measured at the following Visits: 1, 4, 5, 6, 7, EW, and the FU Visit after the participant was in seated position for 5 minutes. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled. |
| Primary | Change From Baseline in Heart Rate at the Indicated Time Points | Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days) | Vital sign assessment included heart rate measured at the following Visits: 1, 4, 5, 6, 7, EW, and the FU Visit after the participant was in seated position for 5 minutes. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled. |
| Primary | Change From Baseline in Body Temperature at the Indicated Time Points | Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days) | Vital sign assessment included body temperature measurements at the following Visits: 1, 4, 5, 6, 7, EW, and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled. |
| Primary | Change From Baseline in Body Height at Indicated Time Points | Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days) | Body height was measured without shoes and wearing light clothing at the following Visits: 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled. |
| Primary | Change From Baseline in Body Weight at the Indicated Time Points | Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days) | Body weight was measured without shoes and wearing light clothing at the following Visits: 1, 4, 5, 6, 7, EW and FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled. |
| Primary | Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points | Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days) | BMI is calculated as weight in kilograms (kg) divided by the square of their height in metres (m\^2). BMI was measured at the following Visits: 1, 4, 5, 6, 7, EW and FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled. |
| Primary | Change From Baseline in Electrocardiogram (ECG) at the Indicated Time Points | Baseline, Eligibility Assessment (Visit 1), EW Visit (up to 178 days) | The 12-lead ECG was recorded in a supine position at the Eligibility Assessment Visitand the EW Visit after having kept a participant at rest in this position for 10 minutes. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled. |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 registered outcomesOutcomes37
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants (Par.) With Any Adverse Event (AE) or Serious Adverse Event (SAE) During the Treatment Period | From the start of study medication until the end of Follow-Up (up to 178 days) | All Subjects Population: all participants who enrolled in the study. | Participants | NUMBER |
| PRIMARY | Number of Participants With AEs Leading to Withdrawal | From the start of study medication until the end of the Follow-Up Visit (up to 178 days) | All Subjects Population | Participants | NUMBER |
| PRIMARY | Number of Participants With Vital Signs Outside the Pre-determined Clinically Important Findings or Outside the Normal Ranges at Any Time During the Study | Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days) | All Subjects Population | Participants | NUMBER |
| PRIMARY | Change From Baseline in SBP and DBP at the Indicated Time Points | Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days) | All Subjects Population | ||
| PRIMARY | Change From Baseline in Heart Rate at the Indicated Time Points | Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days) | All Subjects Population | ||
| PRIMARY | Change From Baseline in Body Temperature at the Indicated Time Points | Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days) | All Subjects Population | ||
| PRIMARY | Change From Baseline in Body Height at Indicated Time Points | Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days) | All Subjects Population | ||
| PRIMARY | Change From Baseline in Body Weight at the Indicated Time Points | Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days) | All Subjects Population | ||
| PRIMARY | Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points | Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days) | All Subjects Population | ||
| PRIMARY | Change From Baseline in Electrocardiogram (ECG) at the Indicated Time Points | Baseline, Eligibility Assessment (Visit 1), EW Visit (up to 178 days) | All Subjects Population |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 outcomesResults by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants (Par.) With Any Adverse Event (AE) or Serious Adverse Event (SAE) During the Treatment Period | Retigabine/Ezogabine TID | Any AE | 4 | Participants | |
| Number of Participants (Par.) With Any Adverse Event (AE) or Serious Adverse Event (SAE) During the Treatment Period | Retigabine/Ezogabine TID | Any SAE | 0 | Participants | |
| Number of Participants With AEs Leading to Withdrawal | Retigabine/Ezogabine TID | 0 | Participants | ||
| Number of Participants With Vital Signs Outside the Pre-determined Clinically Important Findings or Outside the Normal Ranges at Any Time During the Study | Retigabine/Ezogabine TID | 0 | Participants | ||
| Number of Participants With Abnormal Clinically Significant ECG Findings Based on Investigator Judgment at Anytime During the Study | Retigabine/Ezogabine TID | 0 | Participants | ||
| Number of Participants With Sexual Maturation Based on the Tanner Stage I to Stage V of Puberty in Participants <=18 Years Old Throughout the Study | Retigabine/Ezogabine TID | Stage I to Stage II | 0 | Participants | |
| Number of Participants With Sexual Maturation Based on the Tanner Stage I to Stage V of Puberty in Participants <=18 Years Old Throughout the Study | Retigabine/Ezogabine TID | Stage II to Stage III | 0 | Participants | |
| Number of Participants With Sexual Maturation Based on the Tanner Stage I to Stage V of Puberty in Participants <=18 Years Old Throughout the Study | Retigabine/Ezogabine TID | Stage III to Stage IV | 0 | Participants | |
| Number of Participants With Sexual Maturation Based on the Tanner Stage I to Stage V of Puberty in Participants <=18 Years Old Throughout the Study | Retigabine/Ezogabine TID | Stage IV to Stage V | 2 | Participants | |
| Number of Participants With Sexual Maturation Based on the Tanner Stage I to Stage V of Puberty in Participants <=18 Years Old Throughout the Study | Retigabine/Ezogabine TID | Stage V | 2 | Participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Retigabine/Ezogabine TID | 4 | |
| Overall Study | COMPLETED | Retigabine/Ezogabine TID | 0 | |
| Overall Study | NOT COMPLETED | Retigabine/Ezogabine TID | 4 |
Source ClinicalTrials.gov
Adverse events6
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 | Vomiting | Gastrointestinal disorders | Retigabine/Ezogabine TID | 1 | 4 | |
| other | Ingrowing nail | Skin and subcutaneous tissue disorders | Retigabine/Ezogabine TID | 1 | 4 | |
| other | Migraine | Nervous system disorders | Retigabine/Ezogabine TID | 1 | 4 | |
| other | Viral infection | Infections and infestations | Retigabine/Ezogabine TID | 1 | 4 | |
| other | Pyrexia | General disorders | Retigabine/Ezogabine TID | 1 | 4 | |
| other | Headache | Nervous system disorders | Retigabine/Ezogabine TID | 1 | 4 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Retigabine/Ezogabine TID | ||
| Total, other adverse events | Retigabine/Ezogabine TID | 4 | 4 |
| Total, serious adverse events | Retigabine/Ezogabine TID | 0 | 4 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT01668654
GET https://conductscience.org/api/trials/v1/NCT01668654/registered?page=2