Trial · NCT00355082
Conversion To Monotherapy With Lamictal Extended Release Tablets For Treatment Of Partial Epilepsy
NCT00355082, Phase 3, Completed, GlaxoSmithKline; results first posted 2009-11-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Conversion To Monotherapy With Lamictal Extended Release Tablets For Treatment Of Partial Epilepsy. Trials, record NCT00355082. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00355082
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Conversion To Monotherapy With Lamictal Extended Release Tablets For Treatment Of Partial Epilepsy
- NCT number
- NCT00355082
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 226 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Epilepsy, Partial
- Interventions
- lamotrigine, 300 mg/day, lamotrigine, 250 mg/day
- First posted
- 2006-07-21
- Last updated
- 2017-01-02
- Results first posted
- 2009-11-25
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Percentage of Participants in the 300 mg/Day Dose Group Who Prematurely Discontinued the Study Between Study Visit 5 (Approximately Week 7) and Visit 9 (End of the Treatment Phase) | From Study Visit 5 through Visit 9 of the Treatment Phase (approximately Week 7 through Week 23) | The percentage of participants prematurely discontinuing the study was calculated as the number of participants who discontinued the study divided by the number who reached Visit 5 minus major protocol violators. The Control group is composed of data from other similar studies and is not part of this study. |
| Secondary | The Percentage of Participants in the 250 mg/Day Dose Group Who Prematurely Discontinued the Study Between Study Visit 5 (Approximately Week 7) and Visit 9 (End of the Treatment Phase) | From Study Visit 5 through Visit 9 of the Treatment phase (approximately Week 7 through Week 23) | The percentage of participants prematurely discontinuing the study was calculated as the number of participants who discontinued the study divided by the number who had reached Visit 5 minus major protocol violators. The Control group was composed of data from other similar studies and is not part of this study. |
| Secondary | Time to Discontinuation in the Treatment Phase | From Study Visit 5 through Visit 9 of the Treatment phase (approximately Week 7 through Week 23) | Time (days) until the participant discontinued the study |
| Secondary | Percentage of Participants Meeting Escape Criteria in the Treatment Phase | Study Visit 5 through Visit 9 of the Treatment phase (approximately Week 7 through Week 23) | The percentage of participants meeting Escape Criteria was calculated as the number of participants who met an Escape Criterion divided by the number who had reached Visit 5 minus major protocol violators. Escape Criteria are: (1) doubling of average monthly seizure frequency; (2) doubling of the highest consecutive 2-day seizure total; (3) occurrence of a new, more severe seizure type; or (4) worsening of generalized tonic-clonic seizures. |
| Secondary | Percent Change From Baseline in Weekly Seizure Frequency Between Study Visits 3 (Start of Dosing) and 9 (End of the Treatment Phase) | Baseline and Study Visit 3 through Visit 9 of the Treatment phase (Treatment Week 0 through Week 23) | Change from Baseline was measured as the number of seizures at Visits 3 through 9 minus the number of seizures at Baseline. The number of partial seizures during treatment divided by the number of weeks of treatment was compared to the weekly seizure frequency during Baseline. A positive number equals a reduction in seizure frequency. |
| Secondary | Number of Seizure-free Participants During the Last 12 Weeks of Treatment of the Treatment Phase | The last 12 weeks of treatment of the Treatment phase (Monotherapy phase - approximately Week 11 through Week 23) | The number of participants who had no seizures during the treatment period was calculated. The last 12 weeks of treatment were either Weeks 11-22 or 12-23 depending on which background AED was being withdrawn |
| Secondary | Percent Change From Baseline in the Average Seizure Frequency Measured at the End of Participation in the Continuation Phase | Baseline and start of Continuation phase through Week 24 or end of participation in the Continuation phase | Change from baseline was calculated as the average seizure frequency at the end of the Continuation Phase minus the average seizure frequency at Baseline. The number of seizures during the Continuation phase divided by the number of weeks was compared to the number of seizures at Baseline. A positive number indicates a reduction in seizure frequency. |
| Secondary | The Number of Participants With at Least the Specified Change in Seizure Frequency, Compared to Baseline, at the End of Participation in the Continuation Phase (Maximum of 24 Weeks) | Baseline and entire Continuation phase (24 Weeks) | Change in seizure frequency was calculated as the average seizure frequency during the Continuation Phase minus the seizure frequency at Baseline. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Percentage of Participants in the 300 mg/Day Dose Group Who Prematurely Discontinued the Study Between Study Visit 5 (Approximately Week 7) and Visit 9 (End of the Treatment Phase) | From Study Visit 5 through Visit 9 of the Treatment Phase (approximately Week 7 through Week 23) | All randomized participants in the 300 mg/day dose group who began withdrawal of background antiepileptic drug (AED) (Visit 5) minus any major protocol violators | percentage of participants | NUMBER |
| SECONDARY | The Percentage of Participants in the 250 mg/Day Dose Group Who Prematurely Discontinued the Study Between Study Visit 5 (Approximately Week 7) and Visit 9 (End of the Treatment Phase) | From Study Visit 5 through Visit 9 of the Treatment phase (approximately Week 7 through Week 23) | All randomized participants in the 250 mg/day dose group who began withdrawal of background AED (Visit 5) minus any major protocol violators | percentage of participants | NUMBER |
| SECONDARY | Time to Discontinuation in the Treatment Phase | From Study Visit 5 through Visit 9 of the Treatment phase (approximately Week 7 through Week 23) | Intent-to-Treat (ITT) Population: All participants who were randomized and began dosing with study drug | Days | MEAN |
| SECONDARY | Percentage of Participants Meeting Escape Criteria in the Treatment Phase | Study Visit 5 through Visit 9 of the Treatment phase (approximately Week 7 through Week 23) | All randomized participants who began withdrawal of background AED (Visit 5) minus any major protocol violators | percentage of participants | NUMBER |
| SECONDARY | Percent Change From Baseline in Weekly Seizure Frequency Between Study Visits 3 (Start of Dosing) and 9 (End of the Treatment Phase) | Baseline and Study Visit 3 through Visit 9 of the Treatment phase (Treatment Week 0 through Week 23) | All randomized participants who began withdrawal of background AED (Visit 5) minus any major protocol violators | percent change in seizures | MEDIAN |
| SECONDARY | Number of Seizure-free Participants During the Last 12 Weeks of Treatment of the Treatment Phase | The last 12 weeks of treatment of the Treatment phase (Monotherapy phase - approximately Week 11 through Week 23) | All randomized participants who began withdrawal of background AED (Visit 5) minus any major protocol violators | participants | NUMBER |
| SECONDARY | Percent Change From Baseline in the Average Seizure Frequency Measured at the End of Participation in the Continuation Phase | Baseline and start of Continuation phase through Week 24 or end of participation in the Continuation phase | All participants who began the Continuation Phase | percent change in seizures | MEDIAN |
| SECONDARY | The Number of Participants With at Least the Specified Change in Seizure Frequency, Compared to Baseline, at the End of Participation in the Continuation Phase (Maximum of 24 Weeks) | Baseline and entire Continuation phase (24 Weeks) | All participants who entered the Continuation Phase | participants | NUMBER |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Percentage of Participants in the 300 mg/Day Dose Group Who Prematurely Discontinued the Study Between Study Visit 5 (Approximately Week 7) and Visit 9 (End of the Treatment Phase) | Lamotrigine Extended-release (LTG XR), 300 mg | 12 | percentage of participants | ||
| The Percentage of Participants in the 250 mg/Day Dose Group Who Prematurely Discontinued the Study Between Study Visit 5 (Approximately Week 7) and Visit 9 (End of the Treatment Phase) | LTG XR, 250 mg | 16 | percentage of participants | ||
| Time to Discontinuation in the Treatment Phase | Lamotrigine Extended-release (LTG XR), 300 mg | 147.3 | Standard Deviation 31.5 | Days | |
| Time to Discontinuation in the Treatment Phase | LTG XR, 250 mg | 133.2 | Standard Deviation 45.6 | Days | |
| Percentage of Participants Meeting Escape Criteria in the Treatment Phase | Lamotrigine Extended-release (LTG XR), 300 mg | 4 | percentage of participants | ||
| Percentage of Participants Meeting Escape Criteria in the Treatment Phase | LTG XR, 250 mg | 6 | percentage of participants | ||
| Percent Change From Baseline in Weekly Seizure Frequency Between Study Visits 3 (Start of Dosing) and 9 (End of the Treatment Phase) | Lamotrigine Extended-release (LTG XR), 300 mg | 54.8 | Full Range -124.5 to 100.0 | percent change in seizures | |
| Percent Change From Baseline in Weekly Seizure Frequency Between Study Visits 3 (Start of Dosing) and 9 (End of the Treatment Phase) | LTG XR, 250 mg | 52.2 | Full Range -221.3 to 100.0 | percent change in seizures | |
| Number of Seizure-free Participants During the Last 12 Weeks of Treatment of the Treatment Phase | Lamotrigine Extended-release (LTG XR), 300 mg | 22 | participants | ||
| Number of Seizure-free Participants During the Last 12 Weeks of Treatment of the Treatment Phase | LTG XR, 250 mg | 8 | participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-Blind (DB) Treatment Phase | STARTED | Lamotrigine Extended-release (LTG XR), 300 mg | 113 | |
| Double-Blind (DB) Treatment Phase | STARTED | LTG XR, 250 mg | 113 | |
| Double-Blind (DB) Treatment Phase | STARTED | Baseline Failures | 0 | |
| Double-Blind (DB) Treatment Phase | COMPLETED | Lamotrigine Extended-release (LTG XR), 300 mg | 94 | |
| Double-Blind (DB) Treatment Phase | COMPLETED | LTG XR, 250 mg | 79 | |
| Double-Blind (DB) Treatment Phase | COMPLETED | Baseline Failures | 0 | |
| Double-Blind (DB) Treatment Phase | NOT COMPLETED | Lamotrigine Extended-release (LTG XR), 300 mg | 19 | |
| Double-Blind (DB) Treatment Phase | NOT COMPLETED | LTG XR, 250 mg | 34 | |
| Double-Blind (DB) Treatment Phase | NOT COMPLETED | Baseline Failures | 0 | |
| Continuation Phase | STARTED | Lamotrigine Extended-release (LTG XR), 300 mg | 184 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events88
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 | Back pain | Musculoskeletal and connective tissue disorders | Treatment Phase: LTG XR, 300 mg | 0 | 112 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Treatment Phase: LTG XR, 250 mg | 0 | 111 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Continuation Phase: LTG XR, 300 mg | 5 | 184 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Continuation Phase: Baseline Failures | 1 | 11 | |
| other | Dizziness | Nervous system disorders | Treatment Phase: LTG XR, 300 mg | 12 | 112 | |
| other | Dizziness | Nervous system disorders | Treatment Phase: LTG XR, 250 mg | 10 | 111 | |
| other | Dizziness | Nervous system disorders | Continuation Phase: LTG XR, 300 mg | 11 | 184 | |
| other | Dizziness | Nervous system disorders | Continuation Phase: Baseline Failures | 2 | 11 | |
| other | Headache | Nervous system disorders | Treatment Phase: LTG XR, 300 mg | 29 | 112 | |
| other | Headache | Nervous system disorders | Treatment Phase: LTG XR, 250 mg | 31 | 111 |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment Phase: LTG XR, 300 mg | ||
| Total, all-cause mortality | Treatment Phase: LTG XR, 250 mg | ||
| Total, all-cause mortality | Continuation Phase: LTG XR, 300 mg | ||
| Total, all-cause mortality | Continuation Phase: Baseline Failures | ||
| Total, other adverse events | Treatment Phase: LTG XR, 300 mg | 44 | 112 |
| Total, other adverse events | Treatment Phase: LTG XR, 250 mg | 52 | 111 |
| Total, other adverse events | Continuation Phase: LTG XR, 300 mg | 47 | 184 |
| Total, other adverse events | Continuation Phase: Baseline Failures | 4 | 11 |
| Total, serious adverse events | Treatment Phase: LTG XR, 300 mg | 3 | 112 |
| Total, serious adverse events | Treatment Phase: LTG XR, 250 mg | 5 | 111 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Lamotrigine Extended-release (LTG XR), 300 mg vs LTG XR, 250 mg: Number of Seizure-free Participants During the Last 12 Weeks of Treatment of the Treatment Phase |
Source Trial comparisons
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/NCT00355082
GET https://conductscience.org/api/trials/v1/NCT00355082/results?page=2