A Phase 3 interventional study of Clobazam in Dravet Syndrome, sponsored by H. Lundbeck A/S. Terminated at 9 sites in 2 countries. Open to participants aged 1 Year to 16 Years. Per ClinicalTrials.gov, last updated 2017-03-27.
Sponsored by H. Lundbeck A/S · Phase 3, Interventional, and Treatment
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.
87 studies on the registry are indexed under Epilepsies, Myoclonic; 23 are open to participants now.
This study's enrollment of 3 is below the median of 25 across 54 interventional studies indexed under Epilepsies, Myoclonic.
Browse Epilepsies, Myoclonic studies →H. Lundbeck A/S is the lead sponsor of 218 studies on the registry; 10 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 10 (30%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
history of fever-induced prolonged seizures as determined by the Investigator
multiple seizure types which may include:
Other protocol-defined inclusion and exclusion criteria may apply.
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
Drug: Clobazam
Also known as: Onfi®
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time frame: Up to Day 390
Number of Participants With Adverse Events of Special Interest as a Measure of Safety and Tolerability Based on Dose
Time frame: 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
Time frame: Baseline and from Day 0 to Day 360
Change in Behavioural, Neurocognitive Measures Using Vineland Adaptive Behaviour Scale (VABS)
Time frame: Baseline and from Day 0 to Day 360
Change in Mean Weekly Number of Tonic-clonic and Clonic Seizures
Time frame: 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)
Time frame: 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)
Time frame: Baseline and from Day 0 to Day 360
| Milestone | Clobazam |
|---|---|
| Started | 3 |
| Treated | 1 |
| Completed | 0 |
| Not completed | 3 |
| Withdrew: The study was terminated | 3 |
| participants | Clobazam |
|---|---|
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | 0 |
| participants | Clobazam |
|---|---|
| Number of Participants With Adverse Events of Special Interest as a Measure of Safety and Tolerability Based on Dose | 0 |
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Collected over One patient was treated for 33 days before study termination. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Clobazam | — | 0/1 (0%) | 0/1 (0%) |
At the time of study termination, one patient had had been treated
| Age, Continuous(years) | Clobazam |
|---|---|
| Median | 13 (13 to 13) |
| Sex: Female, Male(Participants) | Clobazam |
|---|---|
| Female | 1 |
| Male | 0 |
This study is terminated, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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H. Lundbeck A/S