Trial · NCT03428360
Safety and Tolerability Study of Diazepam Buccal Film (DBF) in Subjects With Epilepsy
NCT03428360, Phase 3, Completed, Aquestive Therapeutics; results first posted 2021-08-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Tolerability Study of Diazepam Buccal Film (DBF) in Subjects With Epilepsy. Trials, record NCT03428360. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03428360
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Tolerability Study of Diazepam Buccal Film (DBF) in Subjects With Epilepsy
- NCT number
- NCT03428360
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 149 participants, actual
- Lead sponsor
- Aquestive Therapeutics
- Conditions
- Epilepsy
- Interventions
- 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
- First posted
- 2018-02-09
- Last updated
- 2021-08-05
- Results first posted
- 2021-08-05
- Limitations and caveats
- Only those subjects who received at least one dose of DBF (130 out of 149) for a breakthrough seizure were included in the Safety Analysis Set.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects in the Safety Analysis Set With at Least 1 Treatment-emergent Adverse Event (TEAE) | Adverse events (AEs) were recorded from Day 1 through the last study contact (Month 7 telephone contact). | 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. |
| Primary | Number of Subjects in Safety Analysis Set With Adverse Events of Special Interest (AESI) | AESIs were recorded from Day 1 through the last study contact (Month 7 telephone contact). | 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 |
| Secondary | Usability Assessment: Number of Use Occasions Where Difficulty in Opening the Outer Packaging Was Recorded. | Recorded in an electronic diary after each use of study drug, throughout the course of the study; approximately 6 months | For each use occasion the following question was asked: Did you have difficulty in opening the outer plastic packaging on this use occasion? Yes |
| Secondary | Usability Assessment: Ability to Open Foil Pouch on Each Use Occasion | Recorded in an electronic diary after each use of study drug, throughout the course of the study; approximately 6 months | 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 |
| Secondary | Usability Assessment: Ability to Remove Study Drug From Foil Pouch on Each Use Occasion | Recorded in an electronic diary after each use of study drug, throughout the course of the study; approximately 6 months | 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 |
| Secondary | Number of Occasions With Successful Insertion/Retention in Cheek | Recorded in an electronic diary after each use of study drug, throughout the course of the study; approximately 6 months | 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 |
| Secondary | Usability Assessment: Difficulty Inserting DBF Against the Buccal Mucosa (Number of Attempts to Insert Film for Each Use Occasion) | Recorded in an electronic diary after each use of study drug, throughout the course of the study; approximately 6 months | 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 |
| Secondary | Usability Assessment: Number of Occasions Where DBF Was Not Placed or Retained on the Inner Cheek Until Dissolution | Recorded in an electronic diary after each use of study drug, throughout the course of the study; approximately 6 months | Number of occasions where the study drug was not successfully placed and or retained in cheek until the film fully dissolved. |
| Secondary | Usability Assessment: Reasons for Multiple Placement/Insertion Attempts During a Use Occasion | Recorded in an electronic diary after each use of study drug, throughout the course of the study; approximately 6 months | 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 |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects in the Safety Analysis Set With at Least 1 Treatment-emergent Adverse Event (TEAE) | Adverse events (AEs) were recorded from Day 1 through the last study contact (Month 7 telephone contact). | Subjects who received at least 1 dose of study drug | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Subjects in Safety Analysis Set With Adverse Events of Special Interest (AESI) | AESIs were recorded from Day 1 through the last study contact (Month 7 telephone contact). | Subjects who received at least 1 dose of study drug | participants | NUMBER |
| SECONDARY | Usability Assessment: Number of Use Occasions Where Difficulty in Opening the Outer Packaging Was Recorded. | Recorded in an electronic diary after each use of study drug, throughout the course of the study; approximately 6 months | Subjects who received at least 1 dose of study drug (Safety Analysis Set) | total number of use occasions | NUMBER |
| SECONDARY | Usability Assessment: Ability to Open Foil Pouch on Each Use Occasion | Recorded in an electronic diary after each use of study drug, throughout the course of the study; approximately 6 months | Number of subjects reporting use occasions | total number of use occasions | COUNT_OF_UNITS |
| SECONDARY | Usability Assessment: Ability to Remove Study Drug From Foil Pouch on Each Use Occasion | Recorded in an electronic diary after each use of study drug, throughout the course of the study; approximately 6 months | Subjects who received at least 1 dose of study drug (Safety Analysis Set) | total number of use occasions rpoeted | COUNT_OF_UNITS |
| SECONDARY | Number of Occasions With Successful Insertion/Retention in Cheek | Recorded in an electronic diary after each use of study drug, throughout the course of the study; approximately 6 months | Subjects who received at least 1 dose of study drug (Safety Analysis Set) | Number of events | NUMBER |
| SECONDARY | Usability Assessment: Difficulty Inserting DBF Against the Buccal Mucosa (Number of Attempts to Insert Film for Each Use Occasion) | Recorded in an electronic diary after each use of study drug, throughout the course of the study; approximately 6 months | Subjects who received at least 1 dose of study drug (Safety Analysis Set) | Number of events | NUMBER |
| SECONDARY | Usability Assessment: Number of Occasions Where DBF Was Not Placed or Retained on the Inner Cheek Until Dissolution | Recorded in an electronic diary after each use of study drug, throughout the course of the study; approximately 6 months | Subjects who received at least 1 dose of study drug (Safety Analysis Set) | total number of use occasions | COUNT_OF_UNITS |
| SECONDARY | Usability Assessment: Reasons for Multiple Placement/Insertion Attempts During a Use Occasion | Recorded in an electronic diary after each use of study drug, throughout the course of the study; approximately 6 months | Subjects who received at least 1 dose of study drug (Safety Analysis Set) | total number of use occasions | NUMBER |
Source ClinicalTrials.gov
Results by group27
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects in the Safety Analysis Set With at Least 1 Treatment-emergent Adverse Event (TEAE) | Safety Analysis Set: Enrolled Subjects With Epilepsy Who Received at Least 1 Dose of Study Drug | At least 1 TEAE | 84 | Participants | |
| Number of Subjects in the Safety Analysis Set With at Least 1 Treatment-emergent Adverse Event (TEAE) | Safety Analysis Set: Enrolled Subjects With Epilepsy Who Received at Least 1 Dose of Study Drug | At least 1 severe TEAE | 14 | Participants | |
| Number of Subjects in the Safety Analysis Set With at Least 1 Treatment-emergent Adverse Event (TEAE) | Safety Analysis Set: Enrolled Subjects With Epilepsy Who Received at Least 1 Dose of Study Drug | At least 1 study drug related TEAE | 10 | Participants | |
| Number of Subjects in the Safety Analysis Set With at Least 1 Treatment-emergent Adverse Event (TEAE) | Safety Analysis Set: Enrolled Subjects With Epilepsy Who Received at Least 1 Dose of Study Drug | At least 1 severe and related TEAE | 1 | Participants | |
| Number of Subjects in the Safety Analysis Set With at Least 1 Treatment-emergent Adverse Event (TEAE) | Safety Analysis Set: Enrolled Subjects With Epilepsy Who Received at Least 1 Dose of Study Drug | At least 1 serious TEAE | 18 | Participants | |
| Number of Subjects in the Safety Analysis Set With at Least 1 Treatment-emergent Adverse Event (TEAE) | Safety Analysis Set: Enrolled Subjects With Epilepsy Who Received at Least 1 Dose of Study Drug | At least 1 serious and related TEAE | 1 | Participants | |
| Number of Subjects in Safety Analysis Set With Adverse Events of Special Interest (AESI) | Subjects With Epilepsy | Any adverse event of special interest | 32 | participants | |
| Number of Subjects in Safety Analysis Set With Adverse Events of Special Interest (AESI) | Subjects With Epilepsy | Any oral irritation adverse event | 3 | participants | |
| Number of Subjects in Safety Analysis Set With Adverse Events of Special Interest (AESI) | Subjects With Epilepsy | Any oral safety adverse event | 8 | participants | |
| Number of Subjects in Safety Analysis Set With Adverse Events of Special Interest (AESI) | Subjects With Epilepsy | Any potential abuse related adverse event | 21 | participants |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Safety Set | 130 | |
| Overall Study | COMPLETED | Safety Set | 90 | |
| Overall Study | NOT COMPLETED | Safety Set | 40 |
Source ClinicalTrials.gov
Adverse events35
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Seizure | Nervous system disorders | Safety Analysis Set | 26 | 130 | 98 |
| other | Somnolence | Nervous system disorders | Safety Analysis Set | 6 | 130 | 6 |
| other | Lethargy | Nervous system disorders | Safety Analysis Set | 4 | 130 | 5 |
| other | Dizziness | Nervous system disorders | Safety Analysis Set | 4 | 130 | 4 |
| other | Headache | Nervous system disorders | Safety Analysis Set | 4 | 130 | 4 |
| other | Upper respiratory tract infection | Infections and infestations | Safety Analysis Set | 8 | 130 | 8 |
| other | Sinusitis | Infections and infestations | Safety Analysis Set | 6 | 130 | 6 |
| other | Ear infection | Infections and infestations | Safety Analysis Set | 4 | 130 | 4 |
| other | Vomiting | Gastrointestinal disorders | Safety Analysis Set | 7 | 130 | 8 |
| other | Nausea | Gastrointestinal disorders | Safety Analysis Set | 5 | 130 | 5 |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Safety Analysis Set | 3 | 130 |
| Total, other adverse events | Safety Analysis Set | 84 | 130 |
| Total, serious adverse events | Safety Analysis Set | 17 | 130 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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