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

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Brief Title

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

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 ≤16 Years With Dravet Syndrome

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.
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Number of Participants With Adverse Events as a Measure of Safety and Tolerability

Secondary Outcome

 Change in Mean Weekly Number of Tonic-clonic and Clonic Seizures

Condition

Dravet Syndrome

Intervention

Clobazam

Study Arms / Comparison Groups

 Clobazam
Description:  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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

3

Start Date

March 2015

Completion Date

October 2015

Primary Completion Date

October 2015

Eligibility Criteria

        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

All

Ages

1 Year - 16 Years

Accepts Healthy Volunteers

No

Contacts

Email contact via H. Lundbeck A/S, , 

Location Countries

Mexico

Location Countries

Mexico

Administrative Informations


NCT ID

NCT02187809

Organization ID

14362B


Responsible Party

Sponsor

Study Sponsor

H. Lundbeck A/S


Study Sponsor

Email contact via H. Lundbeck A/S, Study Director, [email protected]


Verification Date

February 2017