Clinical Trial: Clobazam as Adjunctive Therapy in Paediatric Patients Aged ≥1 to ≤16 Years With Dravet Syndrome

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Multi-site, Prospective, Randomised, Double-blind, Placebo-controlled, Parallel-group, Interventional Study to Evaluate the Efficacy, Safety, and Tolerability of Clobazam as Adjunctive Therapy in Paed

Brief Summary: The purpose of this study is to investigate the effect on the frequency of tonic-clonic and clonic seizures of clobazam as adjunctive therapy compared to placebo after 16 weeks of treatment in paediatric patients aged ≥1 to ≤16 years with Dravet Syndrome.

Detailed Summary:
Sponsor: H. Lundbeck A/S

Current Primary Outcome: Percent change from baseline to study completion/withdrawal in seizure rate for combined tonic-clonic and clonic seizure rates, based upon a calculation of seizure frequency determined from daily seizure diary counts [ Time Frame: Baseline and from week 0 to week 16 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Percent change from baseline to study completion/withdrawal in seizure rate for combined tonic-clonic and clonic seizure rates, based upon a calculation of seizure frequency determined from daily seizure diary counts during 4 weeks of maintenance [ Time Frame: Baseline and from week 4 to week 16 ]
  • Percent change in seizure rate for myoclonic seizures determined from daily seizure diary counts [ Time Frame: Baseline and from week 0 to week 16 ]
  • Percent change in seizure rate for atypical absence seizures determined from daily seizure diary counts [ Time Frame: Baseline and from week 0 to week 16 ]
  • Percent change in seizure rate for complex partial seizures determined from daily seizure diary counts [ Time Frame: Baseline and from week 0 to week 16 ]
  • Percent change in seizure rate for all seizure types determined from daily seizure diary counts [ Time Frame: Baseline and from week 0 to week 16 ]
  • 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 week 0 to week 16 ]
  • 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 week 0 to week 16 ]
  • Percent change in seizure rate for myoclonic seizures determined from video EEG [ Time Frame: Baseline and from week 0 to week 16 ]
  • Percent change in seizure rate for atypical absence seizures determined from video EEG [ Time Frame: Baseline and from week 0 to week 16 ]
  • Change in Symptom and Seizure Activity Scale (Investigator and Parent/caregiver versions) [ Time Frame: Baseline and from week 0 to week 16 ]
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Up to Week 32 ]
  • 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 week 0 to week 16 ]
  • Number of Participants with Adverse Events of special interest as a Measure of Safety and Tolerability based on dose [ Time Frame: Baseline and Week 32 ]
  • Change in Vineland Adaptive Behaviour Scale (VABS) - all adaptive behavior sub-domains and maladaptive behaviors [ Time Frame: Baseline and from week 0 to week 16 ]


Original Secondary Outcome: Same as current

Information By: H. Lundbeck A/S

Dates:
Date Received: June 2, 2014
Date Started: March 2015
Date Completion:
Last Updated: September 23, 2015
Last Verified: September 2015