Trial Outcomes & Findings for Safety and Tolerability of Clobazam as Adjunctive Therapy in Paediatric Patients Aged ≥1 to ≤16 Years With Dravet Syndrome (NCT NCT02187809)
NCT ID: NCT02187809
Last Updated: 2017-03-27
Results Overview
TERMINATED
PHASE3
3 participants
Up to Day 390
2017-03-27
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
Treated
|
1
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Overall Study
The study was terminated
|
3
|
Baseline Characteristics
Safety and Tolerability of Clobazam as Adjunctive Therapy in Paediatric Patients Aged ≥1 to ≤16 Years With Dravet Syndrome
Baseline characteristics by cohort
| Measure |
Clobazam
n=1 Participants
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
|
|---|---|
|
Age, Continuous
|
13 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Up to Day 390Population: At the time of study termination, only one patient had received IMP. No adverse events were observed in the study.
Outcome measures
| Measure |
Clobazam
n=1 Participants
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
|
|---|---|
|
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
|
0 participants
|
PRIMARY outcome
Timeframe: Up to Day 390Population: At the time of study termination, only one patient had received IMP. No adverse events were observed in the study
Outcome measures
| Measure |
Clobazam
n=1 Participants
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
|
|---|---|
|
Number of Participants With Adverse Events of Special Interest as a Measure of Safety and Tolerability Based on Dose
|
0 participants
|
PRIMARY outcome
Timeframe: Baseline and from Day 0 to Day 360Population: At the time of study termination, one patient had received IMP. No C-SSRS data were collected from that single patient.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline and from Day 0 to Day 360Population: At the time of study termination, only one patient had received IMP. No VABS data were recorded for that single patient.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and from Day 0 to Day 360 and upon Study Completion/WithdrawalPopulation: At the time of study termination, only one patient had received IMP. No seizure data were summarised for that single patient.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and from Day 0 to Day 360Population: At the time of study termination, only one patient had received IMP. No seizure data were summarised for that single patient.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and from Day 0 to Day 360Population: At the time of study termination, only one patient had received IMP. No seizure data were summarised for that single patient.
Outcome measures
Outcome data not reported
Adverse Events
Clobazam
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place