Use of Clobazam for Epilepsy and Anxiety

• ClinicalTrials.gov Identifier: NCT03371836
• Recruitment Status: Completed
• First Posted: December 13, 2017
• Results First Posted: March 4, 2021
• Last Update Posted: March 4, 2021
• Sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
• Information provided by (Responsible Party): Jay Salpekar, M.D., Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Study Description

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: N/A
• 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
• Actual Primary Completion Date: December 31, 2019
• Actual Study Completion Date: December 31, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. CGI-I [ Time Frame: 14-18 weeks ]
   Mean of Clinical Global Impression-Improvement from baseline. (1-7 point scale; lower score equals a better outcome; 1 is the maximum improvement, 7 is the minimum improvement)

Eligibility Criteria

• 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

Contacts and Locations

Locations

United States, Maryland

Kennedy Krieger Institute

Baltimore, Maryland, United States, 21205

Sponsors and Collaborators

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Investigators

• 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.:

Study Protocol and Statistical Analysis Plan  [PDF] December 12, 2017

More Information

• Responsible Party: Jay Salpekar, M.D., Principal Investigator, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
• ClinicalTrials.gov Identifier: NCT03371836
• Other Study ID Numbers: onfi90037
• First Posted: December 13, 2017
• Results First Posted: March 4, 2021
• Last Update Posted: March 4, 2021
• Last Verified: February 2021

• 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:

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