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Safety and Tolerability of Clobazam as Adjunctive Therapy in Paediatric Patients Aged ≥1 to ≤16 Years With Dravet Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02187809
Recruitment Status : Terminated (The study was terminated due to recruitment challenges)
First Posted : July 11, 2014
Results First Posted : February 15, 2017
Last Update Posted : March 27, 2017
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Dravet Syndrome
Intervention Drug: Clobazam
Enrollment 3
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Clobazam
Hide Arm/Group Description

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
Period Title: Overall Study
Started 3
Treated 1
Completed 0
Not Completed 3
Reason Not Completed
The study was terminated             3
Arm/Group Title Clobazam
Hide Arm/Group Description

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 Number of Baseline Participants 1
Hide Baseline Analysis Population Description
At the time of study termination, one patient had had been treated
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 1 participants
13
(13 to 13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
1
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Hide Description [Not Specified]
Time Frame Up to Day 390
Hide Outcome Measure Data
Hide Analysis Population Description
At the time of study termination, only one patient had received IMP. No adverse events were observed in the study.
Arm/Group Title Clobazam
Hide Arm/Group Description:

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 Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: participants
0
2.Primary Outcome
Title Number of Participants With Adverse Events of Special Interest as a Measure of Safety and Tolerability Based on Dose
Hide Description [Not Specified]
Time Frame Up to Day 390
Hide Outcome Measure Data
Hide Analysis Population Description
At the time of study termination, only one patient had received IMP. No adverse events were observed in the study
Arm/Group Title Clobazam
Hide Arm/Group Description:

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 Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: participants
0
3.Primary Outcome
Title 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
Hide Description [Not Specified]
Time Frame Baseline and from Day 0 to Day 360
Hide Outcome Measure Data
Hide Analysis Population Description
At the time of study termination, one patient had received IMP. No C-SSRS data were collected from that single patient.
Arm/Group Title Clobazam
Hide Arm/Group Description:

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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Primary Outcome
Title Change in Behavioural, Neurocognitive Measures Using Vineland Adaptive Behaviour Scale (VABS)
Hide Description [Not Specified]
Time Frame Baseline and from Day 0 to Day 360
Hide Outcome Measure Data
Hide Analysis Population Description
At the time of study termination, only one patient had received IMP. No VABS data were recorded for that single patient.
Arm/Group Title Clobazam
Hide Arm/Group Description:

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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Change in Mean Weekly Number of Tonic-clonic and Clonic Seizures
Hide Description [Not Specified]
Time Frame Baseline and from Day 0 to Day 360 and upon Study Completion/Withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
At the time of study termination, only one patient had received IMP. No seizure data were summarised for that single patient.
Arm/Group Title Clobazam
Hide Arm/Group Description:

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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Number of Initial Treatment Responders Who Returned to Their Baseline Tonic-clonic and Clonic Seizure Rate During the Study (an Assessment of Tachyphylaxis)
Hide Description [Not Specified]
Time Frame Baseline and from Day 0 to Day 360
Hide Outcome Measure Data
Hide Analysis Population Description
At the time of study termination, only one patient had received IMP. No seizure data were summarised for that single patient.
Arm/Group Title Clobazam
Hide Arm/Group Description:

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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Percentage of Initial Treatment Responders Who Returned to Their Baseline Tonic-clonic and Clonic Seizure Rate During the Study (an Assessment of Tachyphylaxis)
Hide Description [Not Specified]
Time Frame Baseline and from Day 0 to Day 360
Hide Outcome Measure Data
Hide Analysis Population Description
At the time of study termination, only one patient had received IMP. No seizure data were summarised for that single patient.
Arm/Group Title Clobazam
Hide Arm/Group Description:

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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame One patient was treated for 33 days before study termination
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Clobazam
Hide Arm/Group Description

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
All-Cause Mortality
Clobazam
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Clobazam
Affected / at Risk (%)
Total   0/1 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Clobazam
Affected / at Risk (%)
Total   0/1 (0.00%) 
Early termination leading to small numbers of subjects treated and no analysis. One patient was treated for 33 days.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: H. Lundbeck
Organization: H. Lundbeck A/S
EMail: LundbeckClinicalTrials@Lundbeck.com
Layout table for additonal information
Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT02187809    
Other Study ID Numbers: 14362B
First Submitted: July 9, 2014
First Posted: July 11, 2014
Results First Submitted: October 28, 2016
Results First Posted: February 15, 2017
Last Update Posted: March 27, 2017