Trial · NCT03179891
Study of Diazepam Buccal Film Administered in the Interictal and in the Ictal-Periictal States to Adults With Epilepsy
NCT03179891, Phase 2, Completed, Aquestive Therapeutics; results first posted 2020-09-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Diazepam Buccal Film Administered in the Interictal and in the Ictal-Periictal States to Adults With Epilepsy. Trials, record NCT03179891. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03179891
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Diazepam Buccal Film Administered in the Interictal and in the Ictal-Periictal States to Adults With Epilepsy
- NCT number
- NCT03179891
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 35 participants, actual
- Lead sponsor
- Aquestive Therapeutics
- Conditions
- Epilepsy
- Interventions
- Diazepam Buccal Film 12.5 mg
- First posted
- 2017-06-07
- Last updated
- 2020-09-18
- Results first posted
- 2020-09-18
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Tmax Pharmacokinetic EndPoints | -2 to 0, 0.25, 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 192, 240 hours | Observed time to reach maximum drug concentration (Tmax) |
| Primary | Cmax Pharmacokinetic EndPoints | -2 to 0, 0.25, 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 192, 240 hours | Observed Peak Drug Concentration (Cmax) |
| Primary | Area Under the Plasma Concentration Curve Pharmacokinetic EndPoints | -2 to 0, 0.25, 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 192, 240 hours | Area under the Plasma Concentration -time curve from time zero until the last measured time (AUC0-t) |
| Secondary | Usability Endpoint - Successful Insertion/Placement of the Diazepam Buccal Film (DBF) on First Attempt | Subject was observed for 15 minutes after initial film placement/adhesion | Number of subjects with unsuccessful insertion/placement of the DBF on first attempt at administration Number of subjects with successful insertion/placement of the DBF on first attempt at administration Placement is judged to be successful when film adheres to the center of buccal mucosa of either right or left cheek. Unsuccessful placements were followed by a subsequent successful insertion/placement of DBF |
| Secondary | Usability Endpoint: Swallowing the Film Before Complete Disintegration/Dissolution | Subject was observed for 15 minutes immediately following DBF placement/adhesion | Was the film noted to have been swallowed by the subject ? Yes No Subjects were instructed to swallow any remnants of film still present in oral cavity 15 minutes after initial film placement. Results include subjects who swallowed film at any point during the 15 minutes immediately after initial film placement. |
| Secondary | Usability Endpoint: Retention of Diazepam Buccal Film (DBF) From Placement to Complete Disintegration | Subject was observed for 15 minutes immediately following DBF placement/adhesion | Was the DBF spit out or blown out by the subject after placement on buccal mucosa or did the subject chew, talk, or move the DBF prior to complete disintegration/dissolution? Yes No |
| Secondary | Usability Endpoint: Exit of Saliva During the Time the Diazepam Buccal Film (DBF) Was Adhered to Buccal Mucosa | Subject was observed for 15 minutes immediately following DBF placement/adhesion | The observer documented if any saliva was seen to exit the mouth during the time the DBF was adhered to buccal mucosa |
| Secondary | Usability Endpoint: Amount of Saliva That Exited the Mouth After Film Placement | Subject was observed for 15 minutes immediately following DBF placement/adhesion | If Yes - saliva exited the mouth during the time, estimate in milliliters of the amount of saliva that exited the mouth after DBF placement on the buccal surface |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Tmax Pharmacokinetic EndPoints | -2 to 0, 0.25, 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 192, 240 hours | The pharmacokinetic analysis set comprised only those subjects who contributed a valid pharmacokinetic profile for the given analysis and whose predose concentration of the relevant analyte did not exceed 5% of the subsequent Cmax. | hours | MEDIAN |
| PRIMARY | Cmax Pharmacokinetic EndPoints | -2 to 0, 0.25, 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 192, 240 hours | The pharmacokinetic analysis set comprised only those subjects who contributed a valid pharmacokinetic profile for the given analysis and whose predose concentration of the relevant analyte did not exceed 5% of the subsequent Cmax. | ng/mL | MEAN |
| PRIMARY | Area Under the Plasma Concentration Curve Pharmacokinetic EndPoints | -2 to 0, 0.25, 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 192, 240 hours | The pharmacokinetic analysis set comprised only those subjects who contributed a valid pharmacokinetic profile for the given analysis and whose predose concentration of the relevant analyte did not exceed 5% of the subsequent Cmax. | h*ng/mL | MEAN |
| SECONDARY | Usability Endpoint - Successful Insertion/Placement of the Diazepam Buccal Film (DBF) on First Attempt | Subject was observed for 15 minutes after initial film placement/adhesion | Safety Population comprising all subjects who received at least 1 dose of study drug (Diazepam Buccal Film). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Usability Endpoint: Swallowing the Film Before Complete Disintegration/Dissolution | Subject was observed for 15 minutes immediately following DBF placement/adhesion | Safety Population comprising all subjects who received at least 1 dose of study drug (Diazepam Buccal Film). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Usability Endpoint: Retention of Diazepam Buccal Film (DBF) From Placement to Complete Disintegration | Subject was observed for 15 minutes immediately following DBF placement/adhesion | Safety Population comprising all subjects who received at least 1 dose of study drug (Diazepam Buccal Film). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Usability Endpoint: Exit of Saliva During the Time the Diazepam Buccal Film (DBF) Was Adhered to Buccal Mucosa | Subject was observed for 15 minutes immediately following DBF placement/adhesion | Safety Population comprising all subjects who received at least 1 dose of study drug (Diazepam Buccal Film). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Usability Endpoint: Amount of Saliva That Exited the Mouth After Film Placement | Subject was observed for 15 minutes immediately following DBF placement/adhesion | Safety Population comprising all subjects who received at least 1 dose of study drug (Diazepam Buccal Film). | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Tmax Pharmacokinetic EndPoints | Interictal State | 1.000 | Full Range 0.249 to 4.017 | hours | |
| Tmax Pharmacokinetic EndPoints | Ictal/Peri-ictal State | 0.525 | Full Range 0.250 to 2.033 | hours | |
| Cmax Pharmacokinetic EndPoints | Interictal State | 230.32 | Standard Deviation 89.00 | ng/mL | |
| Cmax Pharmacokinetic EndPoints | Ictal/Peri-ictal State | 209.49 | Standard Deviation 120.18 | ng/mL | |
| Area Under the Plasma Concentration Curve Pharmacokinetic EndPoints | Interictal State | 560.18 | Standard Deviation 219.70 | h*ng/mL | |
| Area Under the Plasma Concentration Curve Pharmacokinetic EndPoints | Ictal/Peri-ictal State | 498.78 | Standard Deviation 319.09 | h*ng/mL | |
| Usability Endpoint - Successful Insertion/Placement of the Diazepam Buccal Film (DBF) on First Attempt | Interictal State | Unsuccessful insertion/placement | 0 | Participants | |
| Usability Endpoint - Successful Insertion/Placement of the Diazepam Buccal Film (DBF) on First Attempt | Ictal/Peri-ictal State | Unsuccessful insertion/placement | 2 | Participants | |
| Usability Endpoint - Successful Insertion/Placement of the Diazepam Buccal Film (DBF) on First Attempt | Interictal State | Successful insertion/placement | 33 | Participants | |
| Usability Endpoint - Successful Insertion/Placement of the Diazepam Buccal Film (DBF) on First Attempt | Ictal/Peri-ictal State | Successful insertion/placement | 31 | Participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Intervention | STARTED | Interictal State First, Then Ictal/Peri-ictal State | 13 | |
| First Intervention | STARTED | Ictal/Peri-Ictal State First, Then Interictal State | 22 | |
| First Intervention | COMPLETED | Interictal State First, Then Ictal/Peri-ictal State | 11 | |
| First Intervention | COMPLETED | Ictal/Peri-Ictal State First, Then Interictal State | 20 | |
| First Intervention | NOT COMPLETED | Interictal State First, Then Ictal/Peri-ictal State | 2 | |
| First Intervention | NOT COMPLETED | Ictal/Peri-Ictal State First, Then Interictal State | 2 | |
| Second Intervention (After 14 Days) | STARTED | Interictal State First, Then Ictal/Peri-ictal State | 11 | |
| Second Intervention (After 14 Days) | STARTED | Ictal/Peri-Ictal State First, Then Interictal State | 20 | |
| Second Intervention (After 14 Days) | COMPLETED | Interictal State First, Then Ictal/Peri-ictal State | 11 | |
| Second Intervention (After 14 Days) | COMPLETED | Ictal/Peri-Ictal State First, Then Interictal State | 20 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events16
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 | Complex Partial Seizures | Nervous system disorders | Interictal State (Period A) | 9 | 33 | 9 |
| other | Complex Partial Seizures | Nervous system disorders | Ictal/Peri-ictal State (Period B) | 14 | 33 | 14 |
| other | Headache | Nervous system disorders | Interictal State (Period A) | 0 | 33 | 0 |
| other | Headache | Nervous system disorders | Ictal/Peri-ictal State (Period B) | 3 | 33 | 3 |
| other | Generalized tonic-clonic seizure | Nervous system disorders | Interictal State (Period A) | 1 | 33 | 6 |
| other | Generalized tonic-clonic seizure | Nervous system disorders | Ictal/Peri-ictal State (Period B) | 1 | 33 | 3 |
| other | Seizure | Nervous system disorders | Interictal State (Period A) | 1 | 33 | 2 |
| other | Seizure | Nervous system disorders | Ictal/Peri-ictal State (Period B) | 1 | 33 | 4 |
| other | Somnolence | Nervous system disorders | Interictal State (Period A) | 2 | 33 | 3 |
| other | Somnolence | Nervous system disorders | Ictal/Peri-ictal State (Period B) | 0 | 33 | 0 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Interictal State (Period A) | 0 | 33 |
| Total, all-cause mortality | Ictal/Peri-ictal State (Period B) | 0 | 33 |
| Total, other adverse events | Interictal State (Period A) | 12 | 33 |
| Total, other adverse events | Ictal/Peri-ictal State (Period B) | 14 | 33 |
| Total, serious adverse events | Interictal State (Period A) | 0 | 33 |
| Total, serious adverse events | Ictal/Peri-ictal State (Period B) | 1 | 33 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Interictal State (Period A) vs Ictal/Peri-ictal State (Period B): deaths from any cause | Trial comparisons |
| Interictal State (Period A) vs Ictal/Peri-ictal State (Period B): serious adverse events | Trial comparisons |
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03179891
GET https://conductscience.org/api/trials/v1/NCT03179891/results?page=2