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Status:

TERMINATED

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

Lead Sponsor:

H. Lundbeck A/S

Conditions:

Dravet Syndrome

Eligibility:

All Genders

1-16 years

Phase:

PHASE3

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.

Eligibility Criteria

Inclusion

  • 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:
  • The patient has a diagnosis of Dravet Syndrome supported by:
  • onset of seizures in the first year of life
  • history of fever-induced prolonged seizures as determined by the Investigator
  • these may include prolonged (approximately 15 minutes or longer) hemi-clonic seizures
  • multiple seizure types which may include:
  • generalised tonic-clonic (required for inclusion)
  • clonic (required for inclusion)
  • myoclonic jerks/seizures
  • history of normal development prior to seizure onset followed by development delay or regression after seizure onset
  • abnormal EEG consistent with Dravet Syndrome
  • 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.

Exclusion

    Key Trial Info

    Start Date :

    March 1 2015

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    October 1 2015

    Estimated Enrollment :

    3 Patients enrolled

    Trial Details

    Trial ID

    NCT02187809

    Start Date

    March 1 2015

    End Date

    October 1 2015

    Last Update

    March 27 2017

    Active Locations (9)

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    Page 1 of 3 (9 locations)

    1

    US010

    Los Angeles, California, United States

    2

    US012

    Orange, California, United States

    3

    US001

    Orlando, Florida, United States

    4

    US003

    Rochester, Minnesota, United States