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

Brief Title

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

Official Title

Multi-site, Prospective, Randomised, Double-blind, Placebo-controlled, Parallel-group, Interventional Study to Evaluate the Efficacy, Safety, and Tolerability of Clobazam as Adjunctive Therapy in Paediatric Patients Aged ≥1 to ≤16 Years With Dravet Syndrome

Brief Summary

      The purpose of this study is to investigate the effect on the frequency of tonic-clonic and
      clonic seizures of clobazam as adjunctive therapy compared to placebo after 16 weeks of
      treatment in paediatric patients aged ≥1 to ≤16 years with Dravet Syndrome.
    

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

Percent change from baseline to study completion/withdrawal in seizure rate for combined tonic-clonic and clonic seizure rates, based upon a calculation of seizure frequency determined from daily seizure diary counts

Secondary Outcome

 Percent change from baseline to study completion/withdrawal in seizure rate for combined tonic-clonic and clonic seizure rates, based upon a calculation of seizure frequency determined from daily seizure diary counts during 4 weeks of maintenance

Condition

Dravet Syndrome

Intervention

Clobazam

Study Arms / Comparison Groups

 Clobazam

Description:  Clobazam - 1.0, 1.5 or 2.0 mg/kg/day (maximum 60 or 80 mg/day) twice daily (BID); Clobazam oral suspension 2.5 mg/mL, 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 Status

Drug

Estimated Enrollment

0

Start Date

March 2015

Completion Date

August 2015

Primary Completion Date

August 2015

Eligibility Criteria

        Inclusion Criteria:

          -  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 2. The patient has a history of
                  approximately 2 tonic-clonic or clonic seizures in 2 weeks 3. The patient is
                  treated with at least 1 but no more than 3 antiepileptic drugs (AEDs) [Vagal
                  Nerve Stimulator (VNS) and ketogenic diet will not be considered an AED] 4.
                  Patient has at least 2 seizures during the Baseline Period of either 2 or 4 weeks

        Exclusion Criteria:

          1. The patient is taking stiripentol, verapamil, or felbatol. If patients have taken
             these drugs in the past, they need to have been off drug for 5 half-lives

          2. The patient is taking a sodium channel blocker including, but not limited to,
             phenytoin, fosphenytoin, carbamazepine, oxcarbamazepine, lamotrigine, lacosamide, and
             rufinamide. If patients have taken these drugs in the past, they need to have been off
             drug for 5 half-lives

          3. The patient is on cannabidiol, medical marijuana, or any drug that contains
             cannabinoids

          4. The patient has received chronic treatment (≥2 weeks for any indication) with a
             benzodiazepine within at least 5 half-lives prior to screening. Rescue therapy for
             prolonged seizures is allowed

          5. The patient has received clobazam within 3 months prior to the Screening Visit. If the
             patient has received clobazam in the past, discontinuation must not have been for
             adverse events or lack of efficacy

        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

NCT ID

NCT02174094

Organization ID

14362A

Responsible Party

Sponsor

Study Sponsor

H. Lundbeck A/S

Study Sponsor

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

Verification Date

September 2015