A Phase 3 interventional study of Diazepam Buccal Soluble Film 5, 7.5,10, 12.5,15 or 17.5 mg with individual dose determined according to age and weight category in Epilepsy, sponsored by Aquestive Therapeutics. Completed at 6 sites in United States. Open to participants aged 2 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-08-05.
Sponsored by Aquestive Therapeutics · Phase 3, Interventional, and Treatment
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 134th largest by enrollment of the 588 interventional ones that give a count, is one of 44 that started in 2018, is one of 126 in phase 3, and was the 460th 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: 2 Years to 65 Years · all sexes · no healthy volunteers.
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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. 44 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 149 is above 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:
Aquestive Therapeutics is the lead sponsor of 9 studies on the registry; none are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.
Aquestive Therapeutics has 4 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:
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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.
The Primary objective of the study is to assess the safety and tolerability of DBF (study drug) administered a minimum of 3 times to subjects with epilepsy for the treatment of seizures over a minimum 6-month period.
Secondary objectives:
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.
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.
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Diazepam Buccal Soluble Film 5, 7.5,10, 12.5,15 or 17.5 mg with individual dose determined according to age and weight category
The subjects in this study administered DBF themselves or with the help of a caregiver, (trained by the study site staff in study drug administration and documentation) in the same setting as they typically used the diazepam rectal gel or other rescue medication, without the presence of study staff.
Also known as: DBF, Diazepam Buccal Film (Aquestive Therapeutics)
Number of Subjects in the Safety Analysis Set With at Least 1 Treatment-emergent Adverse Event (TEAE)
A TEAE was defined as any adverse event with onset date on the day of or after administration of study drug including relationship and severity.
Time frame: Adverse events (AEs) were recorded from Day 1 through the last study contact (Month 7 telephone contact).
Number of Subjects in Safety Analysis Set With Adverse Events of Special Interest (AESI)
A.Oral irritation related AEs including but not limited to: buccal mucosal swelling, mouth ulceration, injuries to oral cavity (such as tongue or mucosal laceration, broken tooth, bleeding), erythema, stomatitis, gingivitis, xerostomia, staining, dysphagia, dysgeusia, burning, stinging, tingling. B. Abuse related AEs including euphoria, euphoric mood, feeling of relaxation, anger, dissociative effects, hallucinations, psychosis, changes in mood, impaired cognition, attention, psychomotor effects, inappropriate affect, overdose, and misuse. C. Other: Respiratory disorders, nervous system disorders
Time frame: AESIs were recorded from Day 1 through the last study contact (Month 7 telephone contact).
Usability Assessment: Number of Use Occasions Where Difficulty in Opening the Outer Packaging Was Recorded.
For each use occasion the following question was asked: Did you have difficulty in opening the outer plastic packaging on this use occasion? Yes
Time frame: Recorded in an electronic diary after each use of study drug, throughout the course of the study; approximately 6 months
Usability Assessment: Ability to Open Foil Pouch on Each Use Occasion
For each use occasion the following question was asked: Did you have difficulty in opening the foil pouch on this use occasion? Yes or No
Time frame: Recorded in an electronic diary after each use of study drug, throughout the course of the study; approximately 6 months
Usability Assessment: Ability to Remove Study Drug From Foil Pouch on Each Use Occasion
For each use occasion the following question was asked: Did you have difficulty in removing study drug from foil pouch on this occasion? Yes or No
Time frame: Recorded in an electronic diary after each use of study drug, throughout the course of the study; approximately 6 months
Number of Occasions With Successful Insertion/Retention in Cheek
Of the total number of use occasions over the course of the study, the number of use occasions that were successfully inserted/retained in the cheek
Time frame: Recorded in an electronic diary after each use of study drug, throughout the course of the study; approximately 6 months
Usability Assessment: Difficulty Inserting DBF Against the Buccal Mucosa (Number of Attempts to Insert Film for Each Use Occasion)
Number of occasions where it took 1 attempt to insert film, Number of occasions where it took 2 attempts to insert film, Number of occasions where it took 3 attempts to insert film, Number of occasions where it took \>3 attempts to insert film
Time frame: Recorded in an electronic diary after each use of study drug, throughout the course of the study; approximately 6 months
Usability Assessment: Number of Occasions Where DBF Was Not Placed or Retained on the Inner Cheek Until Dissolution
Number of occasions where the study drug was not successfully placed and or retained in cheek until the film fully dissolved.
Time frame: Recorded in an electronic diary after each use of study drug, throughout the course of the study; approximately 6 months
Usability Assessment: Reasons for Multiple Placement/Insertion Attempts During a Use Occasion
Reasons for multiple attempts at insertion Multiple choice answer was: Excessive drooling, Clenching jaw / Won't open mouth, Spit out before sticking, Other/None of the above
Time frame: Recorded in an electronic diary after each use of study drug, throughout the course of the study; approximately 6 months
150 subjects with epilepsy passed screening but 1 was never enrolled
| Milestone | Safety Set |
|---|---|
| Started | 130 |
| Completed | 90 |
| Not completed | 40 |
| Withdrew: Informed consent withdrawn | 5 |
| Withdrew: Withdrawal by subject | 4 |
| Withdrew: Lost to follow-up | 5 |
| Withdrew: Physician decision | 2 |
| Withdrew: Informed consent withdrawn | 5 |
| Withdrew: Study terminated by sponsor | 10 |
| Withdrew: Non-compliant with study | 1 |
| Withdrew: Non-compliant with study drug | 3 |
| Withdrew: Death | 3 |
| Withdrew: Adverse event | 1 |
| Withdrew: Not on antiepileptic drug | 1 |
A TEAE was defined as any adverse event with onset date on the day of or after administration of study drug including relationship and severity.
| Participants | Safety Analysis Set: Enrolled Subjects With Epilepsy Who Received at Least 1 Dose of Study Drug |
|---|---|
| At least 1 TEAE | 84 |
| At least 1 severe TEAE | 14 |
| At least 1 study drug related TEAE | 10 |
| At least 1 severe and related TEAE | 1 |
| At least 1 serious TEAE | 18 |
| At least 1 serious and related TEAE | 1 |
A.Oral irritation related AEs including but not limited to: buccal mucosal swelling, mouth ulceration, injuries to oral cavity (such as tongue or mucosal laceration, broken tooth, bleeding), erythema, stomatitis, gingivitis, xerostomia, staining, dysphagia, dysgeusia, burning, stinging, tingling. B. Abuse related AEs including euphoria, euphoric mood, feeling of relaxation, anger, dissociative effects, hallucinations, psychosis, changes in mood, impaired cognition, attention, psychomotor effects, inappropriate affect, overdose, and misuse. C. Other: Respiratory disorders, nervous system disorders
| participants | Subjects With Epilepsy |
|---|---|
| Any adverse event of special interest | 32 |
| Any oral irritation adverse event | 3 |
| Any oral safety adverse event | 8 |
| Any potential abuse related adverse event | 21 |
| Any abuse related adverse event | 1 |
| Any other adverse event of special interest | 8 |
For each use occasion the following question was asked: Did you have difficulty in opening the outer plastic packaging on this use occasion? Yes
| total number of use occasions | Total Use Occasions |
|---|---|
| Usability Assessment: Number of Use Occasions Where Difficulty in Opening the Outer Packaging Was Recorded. | 211 |
For each use occasion the following question was asked: Did you have difficulty in opening the foil pouch on this use occasion? Yes or No
| total number of use occasions | Study Drug Use Occasions |
|---|---|
| Yes, I had difficulty opening the foil pouch | 391 |
| No, I did not have difficulty opening the foil pouch | 957 |
For each use occasion the following question was asked: Did you have difficulty in removing study drug from foil pouch on this occasion? Yes or No
| total number of use occasions rpoeted | Study Drug Use Occasions |
|---|---|
| Yes, I had difficulty removing study drug from pouch on this occasion | 47 |
| No, I did not have difficulty removing study drug from the pouch on this occasion | 1301 |
Of the total number of use occasions over the course of the study, the number of use occasions that were successfully inserted/retained in the cheek
| Number of events | Study Drug Use Occasions |
|---|---|
| Number of Occasions With Successful Insertion/Retention in Cheek | 1330 |
Number of occasions where it took 1 attempt to insert film, Number of occasions where it took 2 attempts to insert film, Number of occasions where it took 3 attempts to insert film, Number of occasions where it took \>3 attempts to insert film
| Number of events | Study Drug Use Occasions |
|---|---|
| Number of occasions where it required 1 attempt to insert film | 1268 |
| Number of occasions that required 2 attempts to insert film | 38 |
| Number of occasions that required 3 attempts to insert film | 18 |
| Number of occasions that required >3 attempts to insert film | 6 |
Number of occasions where the study drug was not successfully placed and or retained in cheek until the film fully dissolved.
| total number of use occasions | Study Drug Use Occasions |
|---|---|
| Usability Assessment: Number of Occasions Where DBF Was Not Placed or Retained on the Inner Cheek Until Dissolution | 16 |
Reasons for multiple attempts at insertion Multiple choice answer was: Excessive drooling, Clenching jaw / Won't open mouth, Spit out before sticking, Other/None of the above
| total number of use occasions | Study Drug Use Occasions |
|---|---|
| Clenching jaw / won't open mouth | 21 |
| Excessive drooling | 24 |
| Spit out before sticking | 17 |
| Other (none of the above) | 33 |
Collected over Adverse events that started after the first intake of DBF through the Final Visit were considered treatment-emergent adverse events (TEAEs).. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Safety Analysis Set | 3/130 (2.3%) | 17/130 (13.1%) | 84/130 (64.6%) |
| Event | Safety Analysis Set |
|---|---|
| SeizureNervous system disorders | 1/130 |
| EpilepsyNervous system disorders | 1/130 |
| Partial seizureNervous system disorders | 1/130 |
| AspirationRespiratory, thoracic and mediastinal disorders | 1/130 |
| Acute respiratory failureRespiratory, thoracic and mediastinal disorders | 1/130 |
| PneumonitisRespiratory, thoracic and mediastinal disorders | 1/130 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 1/130 |
| EnterocolitisGastrointestinal disorders | 1/130 |
| NauseaGastrointestinal disorders | 1/130 |
| Small bowel obstructionGastrointestinal disorders | 1/130 |
| Event | Safety Analysis Set |
|---|---|
| SeizureNervous system disorders | 26/130 |
| Upper respiratory tract infectionInfections and infestations | 8/130 |
| VomitingGastrointestinal disorders | 7/130 |
| PyrexiaGeneral disorders | 7/130 |
| SomnolenceNervous system disorders | 6/130 |
| SinusitisInfections and infestations | 6/130 |
| NauseaGastrointestinal disorders | 5/130 |
| FallInjury, poisoning and procedural complications | 5/130 |
| CoughRespiratory, thoracic and mediastinal disorders | 5/130 |
| LethargyNervous system disorders | 4/130 |
Safety Analysis Set: Enrolled subjects with epilepsy who received at least 1 dose of study drug
| Age, Continuous(years) | Safety Analysis Set: Enrolled Subjects With Epilepsy Who Received at Least 1 Dose of Study Drug |
|---|---|
| Mean | 25.9 ± 13.28 |
| Sex: Female, Male(Participants) | Safety Analysis Set: Enrolled Subjects With Epilepsy Who Received at Least 1 Dose of Study Drug |
|---|---|
| Female | 66 |
| Male | 64 |
| Ethnicity (NIH/OMB)(Participants) | Safety Analysis Set: Enrolled Subjects With Epilepsy Who Received at Least 1 Dose of Study Drug |
|---|---|
| Hispanic or Latino | 29 |
| Not Hispanic or Latino | 99 |
| Unknown or Not Reported | 2 |
| Race (NIH/OMB)(Participants) | Safety Analysis Set: Enrolled Subjects With Epilepsy Who Received at Least 1 Dose of Study Drug |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 5 |
| Native Hawaiian or Other Pacific Islander | 6 |
| Black or African American | 12 |
| White | 99 |
| More than one race | 8 |
| Unknown or Not Reported | 0 |
| Body Mass Index (kg/m^2(kg/m^2) | Safety Analysis Set: Enrolled Subjects With Epilepsy Who Received at Least 1 Dose of Study Drug |
|---|---|
| Mean | 24.108 ± 6.8148 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2018 to primary completion in Jun 2020, 29 months.
Results were first posted in Aug 2021, 1 year 1 month after primary completion.
Of 66 industry-sponsored phase 3 interventional studies under Epilepsy, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 70. This study's 29 months is below that.
Counting every sponsor, half of 85 studies reached it within 48 months; a quarter within 29 and three quarters within 69.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Aquestive Therapeutics