Use of Clobazam for Epilepsy and Anxiety
Condition: Epilepsy; Anxiety
MeSH terms: Epilepsy; Anxiety Disorders
Intervention: Clobazam
Intervention description: Clobazam is used as an adjunct medicine for all participants.
Intervention MeSH terms: Clobazam
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: All participants receive treatment and outcome is assessed; there is no control group.
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: pediatrics

Summary:

      This study is an open label, adjunctive, proof of concept, pilot clinical trial. Pediatric
      patients with epilepsy and clinically significant anxiety will be recruited and if enrolled
      will receive active treatment, involving flexible dose titration of clobazam and will be
      monitored for a period of four months. The study will be monitored and overseen by the Johns
      Hopkins Hospital Institutional Review Board.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Established diagnosis of epilepsy, characterized by focal seizures with suspected or
             documented localization in the temporal lobe. All participants will have active
             epilepsy that requires treatment with anticonvulsant medication.

               -  Although it is not necessary to be seizure free, a seizure baseline period will
                  be established in the 60 days prior to enrollment into the study.

               -  Current regimen of anticonvulsant drugs must have been stable for 30 days prior
                  to entry into the study.

          -  No episodes of seizure clusters of status epilepticus within 30 days prior to entry
             into the study.

          -  Established symptoms of anxiety with functional impairment.

          -  A diagnosis of an anxiety disorder based on the administration of the K-SADS Male or
             female participants equal to or above age 6 and below age 18 at the start of the
             study. No exclusion will be made on the basis of gender or minority status.

          -  Male or female participants equal to or above age 6 and below age 18 at the start of
             the study. No exclusion will be made on the basis of gender or minority status.

          -  Good general health as determined by medical history and physical examination.

          -  Ability to swallow pills (participant will receive pill swallowing instruction if
             necessary). The medicine may be cut into pieces and/or mixed with applesauce.

          -  If female of childbearing age, a negative urine or serum pregnancy test must be
             established or assured at baseline. Additionally, the participant must agree to use
             abstinence or appropriate contraception methods or be otherwise incapable of pregnancy
             for the duration of the study. Pregnancy test results will be shared with parent or
             guardian. Pregnancy status (or prevention) and abstinence or contraception methods
             will be addressed throughout the study for females of childbearing age as well as for
             post-pubertal males.

          -  Previous subjects who failed at any point to meet continuation criteria and withdrew
             early may be considered for re-enrollment by the PI on a case-by-case basis.

          -  Participant or legal caregiver capable of providing informed consent and fully capable
             of monitoring the subject's disease process and compliance with treatment.

        Exclusion criteria:

          -  Previous allergic or hypersensitivity reactions to Onfi® or benzodiazepines

          -  Active substance abuse or dependence within 30 days of enrollment

          -  DSM-V diagnosis of psychotic illness or imminent risk of harm to self or others.

          -  Current standing use of benzodiazepines (except as "rescue" medicine)

          -  Serious or unstable medical or neurologic conditions such as HIV, liver or kidney
             disease, cancer or diabetes.

          -  Participation in a previous experimental drug study within 30 days of baseline visit.

          -  Estimated IQ<70 as indicated by initial clinical assessment (rendering rating scales
             invalid)

          -  Insufficient capacity of caregiver or legal guardian to understand and appropriately
             consent for study procedures