Trial · NCT01160770
Safety and Effectiveness of Open-Label Clobazam in Subjects With Lennox-Gastaut Syndrome
NCT01160770, Phase 3, Completed, Lundbeck LLC; results first posted 2013-05-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Effectiveness of Open-Label Clobazam in Subjects With Lennox-Gastaut Syndrome. Trials, record NCT01160770. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01160770
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Effectiveness of Open-Label Clobazam in Subjects With Lennox-Gastaut Syndrome
- NCT number
- NCT01160770
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 267 participants, actual
- Lead sponsor
- Lundbeck LLC
- Conditions
- Lennox-Gastaut Syndrome
- Interventions
- Clobazam
- First posted
- 2010-07-12
- Last updated
- 2018-03-21
- Results first posted
- 2013-05-06
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Median Percent Reduction in Average Weekly Rate of Drop Seizures Based on the 7-day Assessment | Baseline to month 36 | Number of drop seizures was obtained from seizure diaries |
| Primary | Median Percent Reduction in Average Weekly Rate of Drop Seizures Based on the Last 30-day Assessment | Baseline to month 36 | Number of drop seizures was obtained from seizure diaries |
| Secondary | Percent of Patients Considered Treatment Responders Defined as Those With a ≥25%, ≥50%, ≥75%, 100% Reduction in Drop Seizures Based on the 7-day Assessment | Baseline to month 36 | Number of drop seizures obtained from seizure diaries |
| Secondary | Percent of Patients Considered Treatment Responders Defined as Those With a ≥25%, ≥50%, ≥75%, 100% Reduction in Drop Seizures Based on the Last 30-day Assessment | Baseline to month 36 | Number of drop seizures obtained from seizure diaries |
| Secondary | Investigator Global Evaluations of the Patient's Overall Change in Symptoms | Baseline to month 36 | The physician was asked to rate the patient's overall change in symptoms 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 | Baseline to month 36 | The parent/caregiver was asked to rate the patient's overall change in symptoms 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
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Median Percent Reduction in Average Weekly Rate of Drop Seizures Based on the 7-day Assessment | Baseline to month 36 | percentage of drop seizures | MEDIAN | |
| PRIMARY | Median Percent Reduction in Average Weekly Rate of Drop Seizures Based on the Last 30-day Assessment | Baseline to month 36 | percentage of drop seizures | MEDIAN | |
| SECONDARY | Percent of Patients Considered Treatment Responders Defined as Those With a ≥25%, ≥50%, ≥75%, 100% Reduction in Drop Seizures Based on the 7-day Assessment | Baseline to month 36 | percentage of participants | NUMBER | |
| SECONDARY | Percent of Patients Considered Treatment Responders Defined as Those With a ≥25%, ≥50%, ≥75%, 100% Reduction in Drop Seizures Based on the Last 30-day Assessment | Baseline to month 36 | percentage of participants | NUMBER | |
| SECONDARY | Investigator Global Evaluations of the Patient's Overall Change in Symptoms | Baseline to month 36 | percentage of participants | NUMBER | |
| SECONDARY | Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms | Baseline to month 36 | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Median Percent Reduction in Average Weekly Rate of Drop Seizures Based on the 7-day Assessment | Clobazam | 92.3 | Full Range -588 to 100 | percentage of drop seizures | |
| Median Percent Reduction in Average Weekly Rate of Drop Seizures Based on the Last 30-day Assessment | Clobazam | 92.7 | Full Range -752 to 100 | percentage of drop seizures | |
| Percent of Patients Considered Treatment Responders Defined as Those With a ≥25%, ≥50%, ≥75%, 100% Reduction in Drop Seizures Based on the 7-day Assessment | Clobazam | Any reduction | 85.8 | percentage of participants | |
| Percent of Patients Considered Treatment Responders Defined as Those With a ≥25%, ≥50%, ≥75%, 100% Reduction in Drop Seizures Based on the 7-day Assessment | Clobazam | ≥25% reduction | 82.3 | percentage of participants | |
| Percent of Patients Considered Treatment Responders Defined as Those With a ≥25%, ≥50%, ≥75%, 100% Reduction in Drop Seizures Based on the 7-day Assessment | Clobazam | ≥50% reduction | 77.9 | percentage of participants | |
| Percent of Patients Considered Treatment Responders Defined as Those With a ≥25%, ≥50%, ≥75%, 100% Reduction in Drop Seizures Based on the 7-day Assessment | Clobazam | ≥75% reduction | 64.6 | percentage of participants | |
| Percent of Patients Considered Treatment Responders Defined as Those With a ≥25%, ≥50%, ≥75%, 100% Reduction in Drop Seizures Based on the 7-day Assessment | Clobazam | 100% reduction | 38.1 | percentage of participants | |
| Percent of Patients Considered Treatment Responders Defined as Those With a ≥25%, ≥50%, ≥75%, 100% Reduction in Drop Seizures Based on the Last 30-day Assessment | Clobazam | Any reduction | 86.0 | percentage of participants | |
| Percent of Patients Considered Treatment Responders Defined as Those With a ≥25%, ≥50%, ≥75%, 100% Reduction in Drop Seizures Based on the Last 30-day Assessment | Clobazam | ≥25% reduction | 83.5 | percentage of participants | |
| Percent of Patients Considered Treatment Responders Defined as Those With a ≥25%, ≥50%, ≥75%, 100% Reduction in Drop Seizures Based on the Last 30-day Assessment | Clobazam | ≥50% reduction | 79.3 | percentage of participants |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Clobazam | 267 | |
| Overall Study | COMPLETED | Clobazam | 188 | |
| Overall Study | NOT COMPLETED | Clobazam | 79 |
Source ClinicalTrials.gov
Adverse events191
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 | 35 | 267 | |
| other | Diarrhoea | Gastrointestinal disorders | Clobazam | 19 | 267 | |
| other | Vomiting | Gastrointestinal disorders | Clobazam | 20 | 267 | |
| other | Fatigue | General disorders | Clobazam | 18 | 267 | |
| other | Pyrexia | General disorders | Clobazam | 48 | 267 | |
| other | Ear Infection | Infections and infestations | Clobazam | 15 | 267 | |
| other | Gastroenteritis | Infections and infestations | Clobazam | 14 | 267 | |
| other | Influenza | Infections and infestations | Clobazam | 17 | 267 | |
| other | Nasopharyngitis | Infections and infestations | Clobazam | 31 | 267 | |
| other | Otitis Media | Infections and infestations | Clobazam | 42 | 267 |
1 to 10 of 191Source ClinicalTrials.gov
See all 191 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Clobazam | ||
| Total, other adverse events | Clobazam | 241 | 267 |
| Total, serious adverse events | Clobazam | 115 | 267 |
Source ClinicalTrials.gov
Papers2
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/NCT01160770
GET https://conductscience.org/api/trials/v1/NCT01160770/results?page=2