Trial · NCT00235755
Retigabine Efficacy and Safety Trial for Partial Onset Refractory Seizures in Epilepsy
NCT00235755, Phase 3, Completed, GlaxoSmithKline; results first posted 2011-11-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Retigabine Efficacy and Safety Trial for Partial Onset Refractory Seizures in Epilepsy. Trials, record NCT00235755. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00235755
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Retigabine Efficacy and Safety Trial for Partial Onset Refractory Seizures in Epilepsy
- NCT number
- NCT00235755
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 539 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Seizures
- Interventions
- Retigabine, Retigabine, Placebo
- First posted
- 2005-10-10
- Last updated
- 2017-04-21
- Results first posted
- 2011-11-07
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change in the 28-day Total Partial Seizure (PS) Frequency From Baseline (BL) to the End of the Double-blind (DB) Phase (Titration and Maintenance Phases) | Baseline (Week -7 through Week 0), DB Phase (Week 1 through Week 16) | 28-day total PS (PSs \[also called focal seizures\] are seizures limited to a specific area of the brain) frequency in the BL period = (Number \[No.\] of total PSs reported in the BL period divided by the No. of days of available total PS data in the BL period) x 28 days. 28-day total PS frequency in the DB period = (No. of total PSs reported in the DB period divided by the No. of days of available total PS data in the DB period) x 28 days. Percent change = (\[value in the DB period minus value at BL\] divided by the BL value) x 100%. Negative valu es indicate a reduction in seizure frequency. |
| Primary | Number of Participants Classified as Responders and Non-responders During the Maintenance Phase | Week 5 through Week 16 | Responders were participants with at least a 50% reduction in the 28-day total partial seizure frequency in the Maintenance Phase as compared to the Baseline period. |
| Secondary | Number of Participants Who Were Responders and Non-responders During the DB Phase | Week 1 through Week 16 | Responders were participants with at least a 50% reduction in the 28-day total partial seizure frequency in the DB Phase as compared to the Baseline period. Participants without any post-baseline data were considered non-responders. |
| Secondary | Percent Change From Baseline (BL) in the 28-day Total Partial Seizure Frequency During the Maintenance Phase | Baseline (Week -7 through Week 0), Week 5 through Week 16 | 28-day total partial seizure frequency in the BL period = (No. of total partial seizures reported in the BL period divided by the No. of days of available total partial seizure data in the BL period) x 28 days. 28-day total partial seizure frequency in the Maintenance Phase = (No. of total partial seizures reported in the Maintenance Phase divided by the No. of days of available total partial seizure data in the same phase) x 28 days. Percent change = (value in the Maintenance Phase minus value at BL divided by the BL value) x 100%. Negative values indicate a reduction in seizure frequency. |
| Secondary | Number of Participants With a Reduction in the 28-day Total Partial Seizure Frequency From Baseline to the End of DB Phase (Titration and Maintenance Phases) by Indicated Quartile Reduction Categories | Baseline (Week -7 through Week 0), Week 1 through Week 16 | Participants who experienced a reduction from Baseline in the 28-day total partial seizure frequency were categorized as having a reduction of 75-100%, 50-\<75%, 25-\<50%, or \<25%, in addition to having no reduction. This quartile cutting was specified in the study protocol. Participants without any post-baseline data are included in the "No reduction" category. |
| Secondary | Number of Participants With a Reduction in the 28-day Total Partial Seizure Frequency From Baseline to the DB Phase (Titration and Maintenance Phases) by Indicated Decile Reduction and Increase Categories | Baseline (Week -7 through Week 0), Week 1 through Week 16 | Participants who experienced a reduction from Baseline in the 28-day total partial seizure frequency were categorized in decile cutting, i.e., reduction categories of 90-100%, 80-\<90%, 70-\<80%, 60-\<70%, 50-\<60%, 40-\<50%, 30-\<40%, 20-\<30%, 10-\<20%, \>0-\<10%, and increase categories of 0-10%, \>10-20%, \>20-30%, \>30% (FDA endpoint). Participants without any post-baseline data were included in the category 0-10% increase category. |
| Secondary | Number of Participants With the Indicated Reduction From Baseline in the 28-day Total Partial Seizure Frequency During the Maintenance Phase | Baseline (Week -7 through Week 0), Week 5 through Week 16 | Participants who experienced a reduction from Baseline in the 28-day total partial seizure frequency were categorized as having a \>75%, a 50-75%, or a \<50% reduction, in addition to having no reduction (EMEA endpoint). |
| Secondary | Number of Participants Who Experienced the Indicated Level of Exacerbation and Reduction in the 28-day Total Partial Seizure Frequency From Baseline During the Maintenance Phase | Baseline (Week -7 through Week 0), Week 5 through Week 16 | Participants who experienced an exacerbation from Baseline in the 28-day total partial seizure frequency were categorized as having a 0-25% or a \>25% increase (EMEA endpoint). The number of participants experiencing a \>0% reduction from Baseline in the 28-day total partial seizure frequency are also presented. |
| Secondary | Number of Participants Reporting New Seizure Types in the Indicated Categories During the DB Phase (Titration and Maintenance Phases) That Were Not Reported at Baseline | Baseline (Week -7 through Week 0), Week 1 through Week 16 | New seizure types included those seizures which were not reported by any participant at Baseline. |
| Secondary | Number of Participants Who Were Seizure-free During the DB Phase (Titration and Maintenance Phases) | Week 1 through Week 16 | Participants were considered to be seizure-free if they had not reported any seizures during the DB treatment period (Weeks 1-18). For a participant to be seizure free during the DB Phase, the participant had to be seizure free both Week 7 to Week 18 and Week 1 to Week 6. A participant could be seizure free Week 7 to Week 18 (during the Maintenance Phase), but not seizure free Week 1 to Week 6. Hence, there are fewer participants being reported as seizure free from Week 1 to Week 18 than from Week 7 to Week 18. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change in the 28-day Total Partial Seizure (PS) Frequency From Baseline (BL) to the End of the Double-blind (DB) Phase (Titration and Maintenance Phases) | Baseline (Week -7 through Week 0), DB Phase (Week 1 through Week 16) | Intent-to-Treat Food and Drug Administration (ITT FDA) Population: all randomized participants (P) who received at least 1 dose of study drug. Only participants with post-BL seizure data are included in this analysis. | percent change in seizure frequency | MEDIAN |
| PRIMARY | Number of Participants Classified as Responders and Non-responders During the Maintenance Phase | Week 5 through Week 16 | ITT European Medicines Evaluation Agency (EMEA) Population: all randomized participants who had received at least 1 dose of study drug in the Maintenance Phase and had at least 1 seizure measurement (whether or not they had a seizure) recorded in the Maintenance Phase. | participants | NUMBER |
| SECONDARY | Number of Participants Who Were Responders and Non-responders During the DB Phase | Week 1 through Week 16 | ITT FDA Population | participants | NUMBER |
| SECONDARY | Percent Change From Baseline (BL) in the 28-day Total Partial Seizure Frequency During the Maintenance Phase | Baseline (Week -7 through Week 0), Week 5 through Week 16 | ITT EMEA Population | Percent change in seizure frequency | MEDIAN |
| SECONDARY | Number of Participants With a Reduction in the 28-day Total Partial Seizure Frequency From Baseline to the End of DB Phase (Titration and Maintenance Phases) by Indicated Quartile Reduction Categories | Baseline (Week -7 through Week 0), Week 1 through Week 16 | ITT FDA Population | participants | NUMBER |
| SECONDARY | Number of Participants With a Reduction in the 28-day Total Partial Seizure Frequency From Baseline to the DB Phase (Titration and Maintenance Phases) by Indicated Decile Reduction and Increase Categories | Baseline (Week -7 through Week 0), Week 1 through Week 16 | ITT FDA Population | participants | NUMBER |
| SECONDARY | Number of Participants With the Indicated Reduction From Baseline in the 28-day Total Partial Seizure Frequency During the Maintenance Phase | Baseline (Week -7 through Week 0), Week 5 through Week 16 | ITT EMEA Population | participants | NUMBER |
| SECONDARY | Number of Participants Who Experienced the Indicated Level of Exacerbation and Reduction in the 28-day Total Partial Seizure Frequency From Baseline During the Maintenance Phase | Baseline (Week -7 through Week 0), Week 5 through Week 16 | ITT EMEA Population | participants | NUMBER |
| SECONDARY | Number of Participants Reporting New Seizure Types in the Indicated Categories During the DB Phase (Titration and Maintenance Phases) That Were Not Reported at Baseline | Baseline (Week -7 through Week 0), Week 1 through Week 16 | ITT FDA Population | participants | NUMBER |
| SECONDARY | Number of Participants Who Were Seizure-free During the DB Phase (Titration and Maintenance Phases) | Week 1 through Week 16 | ITT FDA Population. Only participants with post-baseline seizure data were included in the analysis. | participants | NUMBER |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group234
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change in the 28-day Total Partial Seizure (PS) Frequency From Baseline (BL) to the End of the Double-blind (DB) Phase (Titration and Maintenance Phases) | Placebo - Double Blind (DB) Phase (Titration Plus Maintenance) | -15.9 | Full Range -100 to 1712 | percent change in seizure frequency | |
| Percent Change in the 28-day Total Partial Seizure (PS) Frequency From Baseline (BL) to the End of the Double-blind (DB) Phase (Titration and Maintenance Phases) | Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance) | -39.9 | Full Range -100 to 226 | percent change in seizure frequency | |
| Percent Change in the 28-day Total Partial Seizure (PS) Frequency From Baseline (BL) to the End of the Double-blind (DB) Phase (Titration and Maintenance Phases) | Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance) | -27.9 | Full Range -94 to 250 | percent change in seizure frequency | |
| Number of Participants Classified as Responders and Non-responders During the Maintenance Phase | Placebo - DB Phase (Titration Plus Maintenance) | Responders | 31 | participants | |
| Number of Participants Classified as Responders and Non-responders During the Maintenance Phase | Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance) | Responders | 70 | participants | |
| Number of Participants Classified as Responders and Non-responders During the Maintenance Phase | Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance | Responders | 61 | participants | |
| Number of Participants Classified as Responders and Non-responders During the Maintenance Phase | Placebo - DB Phase (Titration Plus Maintenance) | Non-responders | 133 | participants | |
| Number of Participants Classified as Responders and Non-responders During the Maintenance Phase | Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance) | Non-responders | 79 | participants | |
| Number of Participants Classified as Responders and Non-responders During the Maintenance Phase | Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance | Non-responders | 97 | participants | |
| Number of Participants Who Were Responders and Non-responders During the DB Phase | Placebo - DB Phase (Titration Plus Maintenance) | Responders | 31 | participants |
1 to 10 of 234Source ClinicalTrials.gov
See all 234 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| 4-Week Titration Phase | STARTED | Placebo | 179 | |
| 4-Week Titration Phase | STARTED | Retigabine 200 mg TID | 181 | |
| 4-Week Titration Phase | STARTED | Retigabine 300 mg TID | 179 | |
| 4-Week Titration Phase | COMPLETED | Placebo | 168 | |
| 4-Week Titration Phase | COMPLETED | Retigabine 200 mg TID | 162 | |
| 4-Week Titration Phase | COMPLETED | Retigabine 300 mg TID | 153 | |
| 4-Week Titration Phase | NOT COMPLETED | Placebo | 11 | |
| 4-Week Titration Phase | NOT COMPLETED | Retigabine 200 mg TID | 19 | |
| 4-Week Titration Phase | NOT COMPLETED | Retigabine 300 mg TID | 26 | |
| 12-Week Maintenance Phase | STARTED | Placebo | 168 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events354
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 | Dizziness | Nervous system disorders | Placebo - Double Blind (DB) Phase (Titration Plus Maintenance) | 12 | 179 | |
| other | Dizziness | Nervous system disorders | Placebo - Transition Phase | 16 | 147 | |
| other | Dizziness | Nervous system disorders | Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance) | 31 | 181 | |
| other | Dizziness | Nervous system disorders | Retigabine 200 mg TID - Transition Phase | 3 | 132 | |
| other | Dizziness | Nervous system disorders | Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance) | 46 | 178 | |
| other | Dizziness | Nervous system disorders | Retigabine 300 mg TID - Transition Phase | 10 | 114 | |
| other | Somnolence | Nervous system disorders | Placebo - Double Blind (DB) Phase (Titration Plus Maintenance) | 18 | 179 | |
| other | Somnolence | Nervous system disorders | Placebo - Transition Phase | 9 | 147 | |
| other | Somnolence | Nervous system disorders | Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance) | 26 | 181 | |
| other | Somnolence | Nervous system disorders | Retigabine 200 mg TID - Transition Phase | 3 | 132 |
1 to 10 of 354Source ClinicalTrials.gov
See all 354 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo - Double Blind (DB) Phase (Titration Plus Maintenance) | ||
| Total, all-cause mortality | Placebo - Transition Phase | ||
| Total, all-cause mortality | Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance) | ||
| Total, all-cause mortality | Retigabine 200 mg TID - Transition Phase | ||
| Total, all-cause mortality | Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance) | ||
| Total, all-cause mortality | Retigabine 300 mg TID - Transition Phase | ||
| Total, other adverse events | Placebo - Double Blind (DB) Phase (Titration Plus Maintenance) | 56 | 179 |
| Total, other adverse events | Placebo - Transition Phase | 38 | 147 |
| Total, other adverse events | Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance) | 92 | 181 |
| Total, other adverse events | Retigabine 200 mg TID - Transition Phase | 18 | 132 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers4
The papers the trial lists on ClinicalTrials.gov.
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.
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