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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

Tracking Information
First Submitted Date  ICMJE July 9, 2014
First Posted Date  ICMJE July 11, 2014
Results First Submitted Date  ICMJE October 28, 2016
Results First Posted Date  ICMJE February 15, 2017
Last Update Posted Date March 27, 2017
Study Start Date  ICMJE March 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2016)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 9, 2014)
  • 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 History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2016)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2014)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Tolerability of Clobazam as Adjunctive Therapy in Paediatric Patients Aged ≥1 to ≤16 Years With Dravet Syndrome
Official Title  ICMJE Multi-site, Prospective, Open-label, Long-term, Flexible Dose, Interventional Study to Evaluate the Safety and Tolerability of Clobazam as Adjunctive Therapy in Paediatric Patients Aged ≥1 to ≤16 Years With Dravet Syndrome
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Dravet Syndrome
Intervention  ICMJE Drug: Clobazam
Other Name: Onfi®
Study Arms  ICMJE Experimental: 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
Intervention: Drug: Clobazam
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 23, 2015)
3
Original Estimated Enrollment  ICMJE
 (submitted: July 9, 2014)
40
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

  1. The patient has a diagnosis of Dravet Syndrome supported by:

    1. onset of seizures in the first year of life
    2. history of fever-induced prolonged seizures as determined by the Investigator

      • these may include prolonged (approximately 15 minutes or longer) hemi-clonic seizures
    3. multiple seizure types which may include:

      • generalised tonic-clonic (required for inclusion)
      • clonic (required for inclusion)
      • myoclonic jerks/seizures
    4. history of normal development prior to seizure onset followed by development delay or regression after seizure onset
    5. abnormal EEG consistent with Dravet Syndrome
  2. 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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02187809
Other Study ID Numbers  ICMJE 14362B
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party H. Lundbeck A/S
Original Responsible Party Same as current
Current Study Sponsor  ICMJE H. Lundbeck A/S
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
PRS Account H. Lundbeck A/S
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP