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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2015-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Dravet Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Clobazam

Intervention Type DRUG

Interventions

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Clobazam

Intervention Type DRUG

Other Intervention Names

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Onfi®

Eligibility Criteria

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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

Minimum Eligible Age

1 Year

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No