Trial · NCT00518713
Clobazam in Patients With Lennox-Gastaut Syndrome
NCT00518713, Phase 3, Completed, Lundbeck LLC; results first posted 2012-02-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Clobazam in Patients With Lennox-Gastaut Syndrome. Trials, record NCT00518713. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00518713
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clobazam in Patients With Lennox-Gastaut Syndrome
- NCT number
- NCT00518713
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 238 participants, actual
- Lead sponsor
- Lundbeck LLC
- Conditions
- Epilepsy, Epilepsy, Generalized, Seizures
- Interventions
- Clobazam Low Dose, Clobazam Medium Dose, Clobazam High Dose, Placebo
- First posted
- 2007-08-21
- Last updated
- 2012-02-09
- Results first posted
- 2012-02-09
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Reduction in Number of Drop Seizures (12-week Maintenance Period). | 4-week baseline period and 12-week maintenance period | Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal. |
| Secondary | Percent Reduction in Number of Drop Seizures (First 4 Weeks of the 12-week Maintenance Period). | 4-week baseline period and the first 4 weeks of the 12-week maintenance period | Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal. |
| Secondary | Percent Reduction in Number of Drop Seizures (Middle 4 Weeks of the 12-week Maintenance Period). | 4-week baseline period and the middle 4 weeks of the 12-week maintenance period | Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal. |
| Secondary | Percent Reduction in Number of Drop Seizures (Last 4 Weeks of the 12-week Maintenance Period). | 4-week baseline period and the last 4 weeks of the 12-week maintenance period | Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal. |
| Secondary | Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (12-week Maintenance Period). | 4-week baseline period and the 12-week maintenance period | Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal. |
| Secondary | Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (First 4 Weeks of the 12-week Maintenance Period). | 4-week baseline period and the first 4 weeks of the 12-week maintenance period | Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal. |
| Secondary | Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (Middle 4 Weeks of the 12-week Maintenance Period). | 4-week baseline period and the middle 4 weeks of the 12-week maintenance period | Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal. |
| Secondary | Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (Last 4 Weeks of the 12-week Maintenance Period). | 4-week baseline period and the last 4 weeks of the 12-week maintenance period | Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal. |
| Secondary | Tolerance | 4-week baseline period and first 4/first 8 weeks of the maintenance period | Study responders who have ≥50% reduction in their drop seizure rate during the first 4 or first 8 weeks of maintenance compared to the 4 week baseline period. |
| Secondary | Investigator Global Evaluations of the Patient's Overall Change in Symptoms. | Week 15 | The physician was asked to rate the patient's overall change in symptoms and overall change in seizure activity and Quality of Life since the beginning of clobazam treatment by checking "very much improved", "much improved", "minimally improved", "no change", "minimally worse", "much worse", or "very much worse". |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Reduction in Number of Drop Seizures (12-week Maintenance Period). | 4-week baseline period and 12-week maintenance period | Modified Intent-to-Treat (MITT) population | Percent Reduction | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Reduction in Number of Drop Seizures (First 4 Weeks of the 12-week Maintenance Period). | 4-week baseline period and the first 4 weeks of the 12-week maintenance period | MITT population | Percent reduction | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Reduction in Number of Drop Seizures (Middle 4 Weeks of the 12-week Maintenance Period). | 4-week baseline period and the middle 4 weeks of the 12-week maintenance period | Percent reduction | LEAST_SQUARES_MEAN | |
| SECONDARY | Percent Reduction in Number of Drop Seizures (Last 4 Weeks of the 12-week Maintenance Period). | 4-week baseline period and the last 4 weeks of the 12-week maintenance period | Percent reduction | LEAST_SQUARES_MEAN | |
| SECONDARY | Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (12-week Maintenance Period). | 4-week baseline period and the 12-week maintenance period | Percent of responders | NUMBER | |
| SECONDARY | Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (First 4 Weeks of the 12-week Maintenance Period). | 4-week baseline period and the first 4 weeks of the 12-week maintenance period | MITT | Percent of responders | NUMBER |
| SECONDARY | Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (Middle 4 Weeks of the 12-week Maintenance Period). | 4-week baseline period and the middle 4 weeks of the 12-week maintenance period | Percent Responders | NUMBER | |
| SECONDARY | Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (Last 4 Weeks of the 12-week Maintenance Period). | 4-week baseline period and the last 4 weeks of the 12-week maintenance period | Percent Responders | NUMBER | |
| SECONDARY | Tolerance | 4-week baseline period and first 4/first 8 weeks of the maintenance period | MITT | Participants | NUMBER |
| SECONDARY | Investigator Global Evaluations of the Patient's Overall Change in Symptoms. | Week 15 | Those patients in the MITT population who completed a Physician Global Evaluation at Week 15. | participants | NUMBER |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group152
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Reduction in Number of Drop Seizures (12-week Maintenance Period). | Clobazam Low Dose | 41.2 | Full Range -119 to 100 | Percent Reduction | |
| Percent Reduction in Number of Drop Seizures (12-week Maintenance Period). | Clobazam Medium Dose | 49.4 | Full Range -262 to 100 | Percent Reduction | |
| Percent Reduction in Number of Drop Seizures (12-week Maintenance Period). | Clobazam High Dose | 68.3 | Full Range -39 to 100 | Percent Reduction | |
| Percent Reduction in Number of Drop Seizures (12-week Maintenance Period). | Placebo | 12.1 | Full Range -374 to 100 | Percent Reduction | |
| Percent Reduction in Number of Drop Seizures (First 4 Weeks of the 12-week Maintenance Period). | Clobazam Low Dose | 47.8 | Full Range -103 to 100 | Percent reduction | |
| Percent Reduction in Number of Drop Seizures (First 4 Weeks of the 12-week Maintenance Period). | Clobazam Medium Dose | 58.9 | Full Range -147 to 100 | Percent reduction | |
| Percent Reduction in Number of Drop Seizures (First 4 Weeks of the 12-week Maintenance Period). | Clobazam High Dose | 71.0 | Full Range -58 to 100 | Percent reduction | |
| Percent Reduction in Number of Drop Seizures (First 4 Weeks of the 12-week Maintenance Period). | Placebo | 18.6 | Full Range -106 to 100 | Percent reduction | |
| Percent Reduction in Number of Drop Seizures (Middle 4 Weeks of the 12-week Maintenance Period). | Clobazam Low Dose | 44.1 | Full Range -36 to 100 | Percent reduction | |
| Percent Reduction in Number of Drop Seizures (Middle 4 Weeks of the 12-week Maintenance Period). | Clobazam Medium Dose | 38.8 | Full Range -433 to 100 | Percent reduction |
1 to 10 of 152Source ClinicalTrials.gov
See all 152 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Clobazam Low Dose | 58 | |
| Overall Study | STARTED | Clobazam Medium Dose | 62 | |
| Overall Study | STARTED | Clobazam High Dose | 59 | |
| Overall Study | STARTED | Placebo | 59 | |
| Overall Study | Modified Intent-to-Treat Population | Clobazam Low Dose | 53 | |
| Overall Study | Modified Intent-to-Treat Population | Clobazam Medium Dose | 58 | |
| Overall Study | Modified Intent-to-Treat Population | Clobazam High Dose | 49 | |
| Overall Study | Modified Intent-to-Treat Population | Placebo | 57 | |
| Overall Study | COMPLETED | Clobazam Low Dose | 50 | |
| Overall Study | COMPLETED | Clobazam Medium Dose | 45 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events212
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 | Constipation | Gastrointestinal disorders | Clobazam Low Dose | 1 | 58 | |
| other | Constipation | Gastrointestinal disorders | Clobazam Medium Dose | 1 | 62 | |
| other | Constipation | Gastrointestinal disorders | Clobazam High Dose | 6 | 59 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 0 | 59 | |
| other | Diarrhoea | Gastrointestinal disorders | Clobazam Low Dose | 4 | 58 | |
| other | Diarrhoea | Gastrointestinal disorders | Clobazam Medium Dose | 2 | 62 | |
| other | Diarrhoea | Gastrointestinal disorders | Clobazam High Dose | 3 | 59 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 4 | 59 | |
| other | Dysphagia | Gastrointestinal disorders | Clobazam Low Dose | 0 | 58 | |
| other | Dysphagia | Gastrointestinal disorders | Clobazam Medium Dose | 0 | 62 |
1 to 10 of 212Source ClinicalTrials.gov
See all 212 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Clobazam Low Dose | ||
| Total, all-cause mortality | Clobazam Medium Dose | ||
| Total, all-cause mortality | Clobazam High Dose | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Clobazam Low Dose | 42 | 58 |
| Total, other adverse events | Clobazam Medium Dose | 55 | 62 |
| Total, other adverse events | Clobazam High Dose | 45 | 59 |
| Total, other adverse events | Placebo | 40 | 59 |
| Total, serious adverse events | Clobazam Low Dose | 3 | 58 |
| Total, serious adverse events | Clobazam Medium Dose | 6 | 62 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers3
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.
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/NCT00518713
GET https://conductscience.org/api/trials/v1/NCT00518713/results?page=2