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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2015

Interventions

  • Drug: Clobazam

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 1 Year

Maximum Age: 16 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • H. Lundbeck A/S
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Email contact via H. Lundbeck A/S, Study Director, LundbeckClinicalTrials@lundbeck.com

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