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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: 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 &#

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 Summary:
Sponsor: H. Lundbeck A/S

Current Primary Outcome:

  • 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: Same as current

Current Secondary Outcome:

  • 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: Same as current

Information By: H. Lundbeck A/S

Dates:
Date Received: July 9, 2014
Date Started: March 2015
Date Completion:
Last Updated: February 22, 2017
Last Verified: February 2017