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Use of Clobazam for Epilepsy and Anxiety

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ClinicalTrials.gov Identifier: NCT03371836
Recruitment Status : Recruiting
First Posted : December 13, 2017
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Jay Salpekar, M.D., Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Epilepsy Anxiety Drug: Clobazam Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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)
Primary Purpose: Treatment
Official Title: Use of Clobazam in Treating Anxiety Comorbid With Pediatric Epilepsy
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Epilepsy
Drug Information available for: Clobazam

Arm Intervention/treatment
open label single treatment arm
open label
Drug: Clobazam
Clobazam is used as an adjunct medicine for all participants.
Other Name: Onfi




Primary Outcome Measures :
  1. Clinical Global Impression-Improvement (CGI-I) from Baseline [ Time Frame: 14-18 weeks ]
    clinical global outcome rated for epilepsy as well as for anxiety (1-7 point scale)



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03371836


Contacts
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Contact: Clinical Coordinator 443-923-3850 ResearchTrials@kennedykrieger.org

Locations
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United States, Maryland
Kennedy Krieger Institute Recruiting
Baltimore, Maryland, United States, 21205
Contact: Clinical Trials Unit    443-923-3850    ResearchTrials@kennedykrieger.org   
Sponsors and Collaborators
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Investigators
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Principal Investigator: Jay Salpekar, MD KKI/JH
  Study Documents (Full-Text)

Documents provided by Jay Salpekar, M.D., Hugo W. Moser Research Institute at Kennedy Krieger, Inc.:

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Responsible Party: Jay Salpekar, M.D., Principal Investigator, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
ClinicalTrials.gov Identifier: NCT03371836     History of Changes
Other Study ID Numbers: onfi90037
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Jay Salpekar, M.D., Hugo W. Moser Research Institute at Kennedy Krieger, Inc.:
pediatrics
Additional relevant MeSH terms:
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Epilepsy
Anxiety Disorders
Mental Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Clobazam
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action