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Benzodiazepine

Subjects with Epilepsy for Epilepsy (DBF Trial)

Phase 3
Waitlist Available
Research Sponsored by Aquestive Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up recorded in an electronic diary after each use of study drug, throughout the course of the study; approximately 6 months
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Pivotal Trial

Summary

This Phase 3, multicenter, open-label study of chronic, intermittent use of study drug (DBF) is designed to evaluate the safety and tolerability of the buccal formulation of diazepam in children, adolescents and adults with intermittent, stereotypic episodes of frequent seizure activity (eg, seizure clusters) that are distinct from the subject's usual seizure pattern.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~recorded in an electronic diary after each use of study drug, throughout the course of the study; approximately 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and recorded in an electronic diary after each use of study drug, throughout the course of the study; approximately 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Subjects in Safety Analysis Set With Adverse Events of Special Interest (AESI)
Number of Subjects in the Safety Analysis Set With at Least 1 Treatment-emergent Adverse Event (TEAE)
Secondary study objectives
Number of Occasions With Successful Insertion/Retention in Cheek
Usability Assessment: Ability to Open Foil Pouch on Each Use Occasion
Usability Assessment: Ability to Remove Study Drug From Foil Pouch on Each Use Occasion
+4 more

Side effects data

From 2020 Phase 3 trial • 149 Patients • NCT03428360
20%
Seizure
6%
Upper respiratory tract infection
5%
Sinusitis
5%
Somnolence
5%
Vomiting
5%
Pyrexia
4%
Nausea
4%
Cough
4%
Fall
3%
Headache
3%
Dizziness
3%
Lethargy
3%
Ear infection
3%
Diarrhoea
3%
Weight decreased
3%
Skin abrasion
3%
Pneumonia aspiration
3%
Weight increased
1%
Brain neoplasm malignant
1%
Aspiration
1%
Acute respiratory failure
1%
Pneumonitis
1%
Respiratory failure
1%
Enterocolitis
1%
Small bowel obstruction
1%
Joint dislocation
1%
Toxicity to various agents
1%
Pneumonia
1%
Hypokalaemia
1%
Death
1%
Epilepsy
1%
Partial seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Safety Analysis Set

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Subjects with EpilepsyExperimental Treatment1 Intervention
Male or female subjects between the ages of 2 and 65 years who had an established diagnosis of epilepsy exhibited by motor seizures with clear alteration of awareness, and while on a regimen of anti-epileptic medication(s), still experienced bouts of seizures (frequent breakthrough seizures, eg, seizure clusters) and who, in the opinion of the Investigator, could need benzodiazepine intervention for seizure control at least 1 time a month on average. Subjects must have been on at least 1 concomitant anti-epileptic drug at screening.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Diazepam
FDA approved

Find a Location

Who is running the clinical trial?

Aquestive TherapeuticsLead Sponsor
7 Previous Clinical Trials
153 Total Patients Enrolled
3 Trials studying Epilepsy
90 Patients Enrolled for Epilepsy
Syneos HealthOTHER
175 Previous Clinical Trials
68,250 Total Patients Enrolled
1 Trials studying Epilepsy
24 Patients Enrolled for Epilepsy
CovanceIndustry Sponsor
119 Previous Clinical Trials
12,669 Total Patients Enrolled
2 Trials studying Epilepsy
59 Patients Enrolled for Epilepsy
~19 spots leftby Oct 2025
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