Use of Clobazam for Epilepsy and Anxiety

NCT03371836 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: onfi90037
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy; Anxiety

Keywords

pediatrics

Outcome Measures

Primary Outcomes (1)

• CGI-I

  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)

  14-18 weeks

Study Arms (1)

Clobazam

OTHER

open label (single treatment arm)

Drug: Clobazam

Interventions

Clobazam DRUG

Clobazam is used as an adjunct medicine for all participants.

Also known as: Onfi

Clobazam

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hugo W. Moser Research Institute at Kennedy Krieger, Inc.: lead

Study Sites (1)

Kennedy Krieger Institute

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Epilepsy; Anxiety Disorders

Interventions

Clobazam

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Project Director
• Organization: KennedyKrieger

Salpekar@kennedykrieger.org

443-923-7600

Study Officials

• Jay Salpekar, MD

  KKI/JH

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: All participants receive treatment and outcome is assessed; there is no control group.

Study Record Dates

• First Submitted: November 21, 2017
• First Posted: December 13, 2017
• Study Start: October 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: March 4, 2021
• Results First Posted: March 4, 2021

Record last verified: 2021-02

Locations

US (1)