A Phase 4 interventional study of Clobazam in Epilepsy and Anxiety, sponsored by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.. Completed at 1 site in United States. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2021-03-04.
Sponsored by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. · Phase 4, Interventional, and Treatment
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Among 793 studies in Epilepsy with a site in United States — 162 open to participants now, 195 under way, 17 of them phase 3. Epilepsy · United States.
Among the 793 studies in Epilepsy with a site in United States, this one is the 403rd largest by enrollment of the 588 interventional ones that give a count, is one of 31 that started in 2017, is one of 51 in phase 4, and was the 458th registered.
1,848 studies on the registry are indexed under Epilepsy; 420 are open to participants now.
Browse Epilepsy studies →162 of the 793 studies in Epilepsy with a site in United States are open now. Recruiting first, the newest first:
Cadence Neuroscience · Sites in United States
Ages 7+ · Men only
Duke University · Sites in United States
Ages 18–70
NeuroOne Medical Technologies Corporation · Sites in United States
Rapport Therapeutics Inc. · Sites in United States, Australia, Korea, Republic of
Ages 18–75
Dartmouth-Hitchcock Medical Center · Sites in United States
Ages 13–29
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 283 Epilepsy studies recruiting now, 112 (40%) set no upper age limit and 148 (52%) stop at 75 or younger; 140 take children under 18; 55 take healthy volunteers.
This study: 6 Years to 17 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
793 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 82 · Phase 2 126 · Phase 3 133 · Phase 4 51
First in 1975; this study’s year is marked. 31 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 20 is below the median of 50 across 1,239 interventional studies indexed under Epilepsy.
Median enrollment 40 across the 588 interventional studies, 90 across the 193 observational. Of the 525 that completed or were terminated, 243 (46%) have results posted.
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295 of 793 have an industry lead sponsor. The 10 most frequent:
Hugo W. Moser Research Institute at Kennedy Krieger, Inc. is the lead sponsor of 76 studies on the registry; 19 are open to participants now.
Hugo W. Moser Research Institute at Kennedy Krieger, Inc. has 3 studies filed under Epilepsy — fewer than ten, so there is no comparison to draw.
73 of the studies in Epilepsy with a site in United States that are under way reach primary completion within a year, 7 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06132893Phase 3Biohaven Therapeutics Ltd.A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy | 2026-12 |
| NCT07010471Phase 3Praxis Precision MedicinesA Clinical Trial for Participants With DEE to Assess Efficacy, Safety, Tolerability, and PK of Relutrigine | 2026-12 |
| NCT07019922Phase 3Praxis Precision MedicinesA Clinical Trial of Elsunersen in Pediatric SCN2A-DEE to Assess Efficacy and Safety | 2026-12 |
| NCT06660394Phase 3Longboard PharmaceuticalsA Phase 3, Placebo-Controlled Study to Investigate LP352 in Children and Adults With Dravet Syndrome (DS) | 2026-12-31 |
| NCT05431595Phase 3M.D. Anderson Cancer CenterManaging Agitated Delirium With Neuroleptics and Anti-Epileptics as a Neuroleptic Sparing Strategy | 2027-02-02 |
Add all 73 to your calendar (.ics) → With an account.
Among the 793 studies in Epilepsy with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
open label (single treatment arm)
Drug: Clobazam
Clobazam is used as an adjunct medicine for all participants.
Also known as: Onfi
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)
Time frame: 14-18 weeks
| Milestone | Clobazam |
|---|---|
| Started | 20 |
| Completed | 18 |
| Not completed | 2 |
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)
| units on a scale | Clobazam |
|---|---|
| CGI-I | 2 (1 to 7) |
Collected over up to 18 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Open Label Single Treatment Arm | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Age, Categorical(Participants) | Open Label Single Treatment Arm |
|---|---|
| <=18 years | 20 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Age, Continuous(years) | Open Label Single Treatment Arm |
|---|---|
| Mean | 13.8 (6 to 17) |
| Sex: Female, Male(Participants) | Open Label Single Treatment Arm |
|---|---|
| Female | 16 |
| Male | 4 |
| Race (NIH/OMB)(Participants) | Open Label Single Treatment Arm |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 5 |
| White | 14 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(Participants) | Open Label Single Treatment Arm |
|---|---|
| United States | 20 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Oct 2017 to primary completion in Dec 2019, 26 months.
Results were first posted in Mar 2021, 1 year 2 months after primary completion.
Of 33 non-industry phase 4 interventional studies under Epilepsy, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 37. This study's 26 months is close to that.
Counting every sponsor, half of 43 studies reached it within 25 months; a quarter within 12 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Clobazam
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.