Use of Clobazam for Epilepsy and Anxiety



Status:Recruiting
Conditions:Anxiety, Neurology, Epilepsy
Therapuetic Areas:Neurology, Psychiatry / Psychology, Other
Healthy:No
Age Range:6 - 17
Updated:2/17/2019
Start Date:October 1, 2017
End Date:December 31, 2019
Contact:Clinical Coordinator
Email:ResearchTrials@kennedykrieger.org
Phone:443-923-3850

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Use of Clobazam in Treating Anxiety Comorbid With Pediatric Epilepsy

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.


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
We found this trial at
1
site
707 North Broadway
Baltimore, Maryland 21205
443-923-9200
Phone: 443-923-3850
Kennedy Krieger Institute While not officially part of Johns Hopkins Medicine, Kennedy Krieger Institute is...
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from
Baltimore, MD
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