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The study was terminated due to recruitment challenges
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To investigate the long-term safety and tolerability of clobazam when administered for 1 year as adjunctive therapy in paediatric patients aged ≥1 to ≤16 years with Dravet Syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clobazam | Experimental | A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clobazam | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | Up to Day 390 | |
| Number of Participants With Adverse Events of Special Interest as a Measure of Safety and Tolerability Based on Dose | Up to Day 390 | |
| 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 | |
| Change in Behavioural, Neurocognitive Measures Using Vineland Adaptive Behaviour Scale (VABS) | Baseline and from Day 0 to Day 360 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Weekly Number of Tonic-clonic and Clonic Seizures | Baseline and from Day 0 to Day 360 and upon Study Completion/Withdrawal | |
| Number of Initial Treatment Responders Who Returned to Their Baseline Tonic-clonic and Clonic Seizure Rate During the Study (an Assessment of Tachyphylaxis) |
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The inclusion and exclusion criteria for the patients who participated in lead-in Study 14362A will be transferred from the 14362A study and for the patients who did not participate in lead-in Study 14362A the inclusion/exclusion is separately listed below.
Inclusion Criteria:
The patient has a diagnosis of Dravet Syndrome supported by:
onset of seizures in the first year of life
history of fever-induced prolonged seizures as determined by the Investigator
multiple seizure types which may include:
history of normal development prior to seizure onset followed by development delay or regression after seizure onset
abnormal EEG consistent with Dravet Syndrome
The patient is currently receiving a stable dose of clobazam of at least 0.5 mg/kg/day (maximum 20 mg/day) for at least 3 months
Other protocol-defined inclusion and exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@lundbeck.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| US010 | Los Angeles | California | United States | |||
| US012 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Clobazam | A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally Clobazam |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Baseline and from Day 0 to Day 360 |
| 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 |
| Orange |
| California |
| United States |
| US001 | Orlando | Florida | United States |
| US003 | Rochester | Minnesota | United States |
| US005 | Kansas City | Missouri | United States |
| US0011 | Dallas | Texas | United States |
| US006 | Dallas | Texas | United States |
| US004 | Seattle | Washington | United States |
| MX003 | Guadalajara | Mexico |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
At the time of study termination, one patient had had been treated
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| ID | Title | Description |
|---|---|---|
| BG000 | Clobazam | A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally Clobazam |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events as a Measure of Safety and Tolerability | At the time of study termination, only one patient had received IMP. No adverse events were observed in the study. | Posted | Number | participants | Up to Day 390 |
|
|
| |||||||||||||||||||||||||||
| Primary | Number of Participants With Adverse Events of Special Interest as a Measure of Safety and Tolerability Based on Dose | At the time of study termination, only one patient had received IMP. No adverse events were observed in the study | Posted | Number | participants | 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 | At the time of study termination, one patient had received IMP. No C-SSRS data were collected from that single patient. | Posted | Baseline and from Day 0 to Day 360 |
|
| ||||||||||||||||||||||||||||||
| Primary | Change in Behavioural, Neurocognitive Measures Using Vineland Adaptive Behaviour Scale (VABS) | At the time of study termination, only one patient had received IMP. No VABS data were recorded for that single patient. | Posted | Baseline and from Day 0 to Day 360 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Change in Mean Weekly Number of Tonic-clonic and Clonic Seizures | At the time of study termination, only one patient had received IMP. No seizure data were summarised for that single patient. | Posted | 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) | At the time of study termination, only one patient had received IMP. No seizure data were summarised for that single patient. | Posted | Baseline and from Day 0 to Day 360 |
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| Secondary | Percentage of Initial Treatment Responders Who Returned to Their Baseline Tonic-clonic and Clonic Seizure Rate During the Study (an Assessment of Tachyphylaxis) | At the time of study termination, only one patient had received IMP. No seizure data were summarised for that single patient. | Posted | Baseline and from Day 0 to Day 360 |
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|
One patient was treated for 33 days before study termination
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Clobazam | A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally Clobazam | 0 | 1 | 0 | 1 |
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Early termination leading to small numbers of subjects treated and no analysis. One patient was treated for 33 days.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| H. Lundbeck | H. Lundbeck A/S | LundbeckClinicalTrials@Lundbeck.com |
| ID | Term |
|---|---|
| D004831 | Epilepsies, Myoclonic |
| ID | Term |
|---|---|
| D004829 | Epilepsy, Generalized |
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000073376 | Epileptic Syndromes |
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| ID | Term |
|---|---|
| D000078306 | Clobazam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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