Trial · NCT02187809
Safety and Tolerability of Clobazam as Adjunctive Therapy in Paediatric Patients Aged ≥1 to ≤16 Years With Dravet Syndrome
NCT02187809, Phase 3, Terminated, H. Lundbeck A/S; results first posted 2017-02-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Tolerability of Clobazam as Adjunctive Therapy in Paediatric Patients Aged ≥1 to ≤16 Years With Dravet Syndrome. Trials, record NCT02187809. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02187809
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Tolerability of Clobazam as Adjunctive Therapy in Paediatric Patients Aged ≥1 to ≤16 Years With Dravet Syndrome
- NCT number
- NCT02187809
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 3 participants, actual
- Lead sponsor
- H. Lundbeck A/S
- Conditions
- Dravet Syndrome
- Interventions
- Clobazam
- First posted
- 2014-07-11
- Last updated
- 2017-03-27
- Results first posted
- 2017-02-15
- Limitations and caveats
- Early termination leading to small numbers of subjects treated and no analysis. One patient was treated for 33 days.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events as a Measure of Safety and Tolerability | Up to Day 390 | |
| Primary | Number of Participants With Adverse Events of Special Interest as a Measure of Safety and Tolerability Based on Dose | Up to Day 390 | |
| Primary | Columbia Suicide Severity Rating Scale (C-SSRS), Categorisation Based on Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories (1, 2, 3, 4 and 7) for Patients Aged ≥ 6 Years | Baseline and from Day 0 to Day 360 | |
| Primary | Change in Behavioural, Neurocognitive Measures Using Vineland Adaptive Behaviour Scale (VABS) | Baseline and from Day 0 to Day 360 | |
| Secondary | Change in Mean Weekly Number of Tonic-clonic and Clonic Seizures | Baseline and from Day 0 to Day 360 and upon Study Completion/Withdrawal | |
| Secondary | Number of Initial Treatment Responders Who Returned to Their Baseline Tonic-clonic and Clonic Seizure Rate During the Study (an Assessment of Tachyphylaxis) | Baseline and from Day 0 to Day 360 | |
| Secondary | Percentage of Initial Treatment Responders Who Returned to Their Baseline Tonic-clonic and Clonic Seizure Rate During the Study (an Assessment of Tachyphylaxis) | Baseline and from Day 0 to Day 360 |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events as a Measure of Safety and Tolerability | Up to Day 390 | At the time of study termination, only one patient had received IMP. No adverse events were observed in the study. | participants | NUMBER |
| PRIMARY | Number of Participants With Adverse Events of Special Interest as a Measure of Safety and Tolerability Based on Dose | Up to Day 390 | At the time of study termination, only one patient had received IMP. No adverse events were observed in the study | participants | NUMBER |
| PRIMARY | Columbia Suicide Severity Rating Scale (C-SSRS), Categorisation Based on Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories (1, 2, 3, 4 and 7) for Patients Aged ≥ 6 Years | Baseline and from Day 0 to Day 360 | At the time of study termination, one patient had received IMP. No C-SSRS data were collected from that single patient. | ||
| PRIMARY | Change in Behavioural, Neurocognitive Measures Using Vineland Adaptive Behaviour Scale (VABS) | Baseline and from Day 0 to Day 360 | At the time of study termination, only one patient had received IMP. No VABS data were recorded for that single patient. | ||
| SECONDARY | Change in Mean Weekly Number of Tonic-clonic and Clonic Seizures | Baseline and from Day 0 to Day 360 and upon Study Completion/Withdrawal | At the time of study termination, only one patient had received IMP. No seizure data were summarised for that single patient. | ||
| SECONDARY | Number of Initial Treatment Responders Who Returned to Their Baseline Tonic-clonic and Clonic Seizure Rate During the Study (an Assessment of Tachyphylaxis) | Baseline and from Day 0 to Day 360 | At the time of study termination, only one patient had received IMP. No seizure data were summarised for that single patient. | ||
| SECONDARY | Percentage of Initial Treatment Responders Who Returned to Their Baseline Tonic-clonic and Clonic Seizure Rate During the Study (an Assessment of Tachyphylaxis) | Baseline and from Day 0 to Day 360 | At the time of study termination, only one patient had received IMP. No seizure data were summarised for that single patient. |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | Clobazam | 0 | participants | ||
| Number of Participants With Adverse Events of Special Interest as a Measure of Safety and Tolerability Based on Dose | Clobazam | 0 | participants |
Source ClinicalTrials.gov
Participant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Clobazam | 3 | |
| Overall Study | Treated | Clobazam | 1 | |
| Overall Study | COMPLETED | Clobazam | 0 | |
| Overall Study | NOT COMPLETED | Clobazam | 3 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse 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 | 0 | 1 |
| Total, serious adverse events | Clobazam | 0 | 1 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT02187809
GET https://conductscience.org/api/trials/v1/NCT02187809/registered