Trial · NCT00162981
Clobazam in Subjects With Lennox-Gastaut Syndrome
NCT00162981, Phase 2, Completed, Lundbeck LLC; results first posted 2012-02-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clobazam in Subjects With Lennox-Gastaut Syndrome. Trials, record NCT00162981. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00162981
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clobazam in Subjects With Lennox-Gastaut Syndrome
- NCT number
- NCT00162981
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 68 participants, actual
- Lead sponsor
- Lundbeck LLC
- Conditions
- Epilepsy, Epilepsy, Generalized, Seizures
- Interventions
- Clobazam Low Dose, Clobazam High Dose
- First posted
- 2005-09-13
- Last updated
- 2012-02-09
- Results first posted
- 2012-02-09
Source ClinicalTrials.gov
Registered outcomes5
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. | 4-week baseline period and 4-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. |
| Primary | A Comparison of the High Dose Group to Low Dose Group of the Percent Reduction in Number of Drop Seizures. | 4-week baseline period and the 4-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%, and 100% Reduction in Drop Seizures. | 4-week baseline period and 4-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 | Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms. | Week 3 | The parent/caregiver 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". |
| Secondary | Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms. | Week 7 | The parent/caregiver 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". |
Source ClinicalTrials.gov
Outcomes5
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. | 4-week baseline period and 4-week maintenance period | Modified Intention-to-Treat (MITT) populations consist of all randomized patients who received study medication and who have both a baseline and post-baseline measurement and have at least one measurement during the maintenance period. | Percent Reduction | MEAN |
| SECONDARY | Percent of Patients Considered Treatment Responders Defined as Those With a >= 25%, >= 50%, >= 75%, and 100% Reduction in Drop Seizures. | 4-week baseline period and 4-week maintenance period | Percent of participants | NUMBER | |
| SECONDARY | Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms. | Week 3 | MITT population, baseline evaluations compared to Week 3 evaluations. | participants | NUMBER |
| PRIMARY | A Comparison of the High Dose Group to Low Dose Group of the Percent Reduction in Number of Drop Seizures. | 4-week baseline period and the 4-week maintenance period | MITT population | Percent Reduction | MEDIAN |
| SECONDARY | Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms. | Week 7 | MITT population, baseline evaluations compared to Week 7 evaluations. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group40
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. | Clobazam Low Dose | 10.1 | Standard Deviation 122.3 | Percent Reduction | |
| Percent Reduction in Number of Drop Seizures. | Clobazam High Dose | 85.2 | Standard Deviation 17.1 | Percent Reduction | |
| Percent of Patients Considered Treatment Responders Defined as Those With a >= 25%, >= 50%, >= 75%, and 100% Reduction in Drop Seizures. | Clobazam Low Dose | ≥ 25% reduction | 18 | Percent of participants | |
| Percent of Patients Considered Treatment Responders Defined as Those With a >= 25%, >= 50%, >= 75%, and 100% Reduction in Drop Seizures. | Clobazam High Dose | ≥ 25% reduction | 32 | Percent of participants | |
| Percent of Patients Considered Treatment Responders Defined as Those With a >= 25%, >= 50%, >= 75%, and 100% Reduction in Drop Seizures. | Clobazam Low Dose | ≥ 50% reduction | 12 | Percent of participants | |
| Percent of Patients Considered Treatment Responders Defined as Those With a >= 25%, >= 50%, >= 75%, and 100% Reduction in Drop Seizures. | Clobazam High Dose | ≥ 50% reduction | 30 | Percent of participants | |
| Percent of Patients Considered Treatment Responders Defined as Those With a >= 25%, >= 50%, >= 75%, and 100% Reduction in Drop Seizures. | Clobazam Low Dose | ≥ 75% reduction | 7 | Percent of participants | |
| Percent of Patients Considered Treatment Responders Defined as Those With a >= 25%, >= 50%, >= 75%, and 100% Reduction in Drop Seizures. | Clobazam High Dose | ≥ 75% reduction | 23 | Percent of participants | |
| Percent of Patients Considered Treatment Responders Defined as Those With a >= 25%, >= 50%, >= 75%, and 100% Reduction in Drop Seizures. | Clobazam Low Dose | 100% reduction | 2 | Percent of participants | |
| Percent of Patients Considered Treatment Responders Defined as Those With a >= 25%, >= 50%, >= 75%, and 100% Reduction in Drop Seizures. | Clobazam High Dose | 100% reduction | 8 | Percent of participants |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Clobazam Low Dose | 32 | |
| Overall Study | STARTED | Clobazam High Dose | 36 | |
| Overall Study | COMPLETED | Clobazam Low Dose | 28 | |
| Overall Study | COMPLETED | Clobazam High Dose | 30 | |
| Overall Study | NOT COMPLETED | Clobazam Low Dose | 4 | |
| Overall Study | NOT COMPLETED | Clobazam High Dose | 6 |
Source ClinicalTrials.gov
Adverse events62
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 | Abnormal Behavior | Psychiatric disorders | Clobazam Low Dose | 0 | 32 | |
| other | Abnormal Behavior | Psychiatric disorders | Clobazam High Dose | 2 | 36 | |
| other | Aggression | Psychiatric disorders | Clobazam Low Dose | 2 | 32 | |
| other | Aggression | Psychiatric disorders | Clobazam High Dose | 3 | 36 | |
| other | Constipation | Gastrointestinal disorders | Clobazam Low Dose | 1 | 32 | |
| other | Constipation | Gastrointestinal disorders | Clobazam High Dose | 3 | 36 | |
| other | Contusion | Injury, poisoning and procedural complications | Clobazam Low Dose | 2 | 32 | |
| other | Contusion | Injury, poisoning and procedural complications | Clobazam High Dose | 0 | 36 | |
| other | Convulsion | Nervous system disorders | Clobazam Low Dose | 3 | 32 | |
| other | Convulsion | Nervous system disorders | Clobazam High Dose | 1 | 36 |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 adverse eventsAdverse event totals6
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 High Dose | ||
| Total, other adverse events | Clobazam Low Dose | 27 | 32 |
| Total, other adverse events | Clobazam High Dose | 31 | 36 |
| Total, serious adverse events | Clobazam Low Dose | 1 | 32 |
| Total, serious adverse events | Clobazam High Dose | 3 | 36 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 19170737 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Clobazam Low Dose vs Clobazam High Dose: serious adverse events |
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/NCT00162981
GET https://conductscience.org/api/trials/v1/NCT00162981/results?page=2