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Study of Diazepam Buccal Film Administered in the Interictal and in the Ictal-Periictal States to Adults With Epilepsy
Phase 2 trial testing Diazepam Buccal Film 12.5 mg in Epilepsy in 35 participants. Completed in 21 December 2018.
| Lead sponsor | Aquestive Therapeutics |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 35 |
| Start date | 25 May 2017 |
| Primary completion | 25 July 2018 |
| Estimated completion | 21 December 2018 |
| Sites | 11 locations across United States |
Aquestive Therapeutics — full company profile →
Adults 18 to 65, any sex, with Epilepsy. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Observed time to reach maximum drug concentration (Tmax)
| Group | Value | 95% CI |
|---|---|---|
| Interictal State | 1.000 | 0.249 – 4.017 |
| Ictal/Peri-ictal State | 0.525 | 0.250 – 2.033 |
Observed Peak Drug Concentration (Cmax)
| Group | Value | 95% CI |
|---|---|---|
| Interictal State | 230.32 | ± 89.00 |
| Ictal/Peri-ictal State | 209.49 | ± 120.18 |
Area under the Plasma Concentration -time curve from time zero until the last measured time (AUC0-t)
| Group | Value | 95% CI |
|---|---|---|
| Interictal State | 560.18 | ± 219.70 |
| Ictal/Peri-ictal State | 498.78 | ± 319.09 |
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
| Group | Value | 95% CI |
|---|---|---|
| Interictal State | 0 | |
| Ictal/Peri-ictal State | 2 |
| Group | Value | 95% CI |
|---|---|---|
| Interictal State | 33 | |
| Ictal/Peri-ictal State | 31 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Interictal State | 4 | |
| Ictal/Peri-ictal State | 2 |
| Group | Value | 95% CI |
|---|---|---|
| Interictal State | 29 | |
| Ictal/Peri-ictal State | 31 |
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
| Group | Value | 95% CI |
|---|---|---|
| Interictal State | 0 | |
| Ictal/Peri-ictal State | 3 |
| Group | Value | 95% CI |
|---|---|---|
| Interictal State | 33 | |
| Ictal/Peri-ictal State | 30 |
The observer documented if any saliva was seen to exit the mouth during the time the DBF was adhered to buccal mucosa
| Group | Value | 95% CI |
|---|---|---|
| Interictal State | 0 | |
| Ictal/Peri-ictal State | 2 |
| Group | Value | 95% CI |
|---|---|---|
| Interictal State | 33 | |
| Ictal/Peri-ictal State | 31 |
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
| Group | Value | 95% CI |
|---|---|---|
| Interictal State | 33 | |
| Ictal/Peri-ictal State | 31 |
| Group | Value | 95% CI |
|---|---|---|
| Interictal State | 0 | |
| Ictal/Peri-ictal State | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Interictal State | 0 | |
| Ictal/Peri-ictal State | 1 |
Time frame: Adverse events were collected throughout the course of the study for each subject (approximately 1 month for each subject - beginning with the first DBF dose until 14 ± 2 days following the second DBF dose).. Reporting threshold: 3%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Interictal State (Period A) | Ictal/Peri-ictal State (Pe… |
|---|---|---|---|
| HOSPITALIZATION DUE TO SEIZURE CLUSTER | Nervous system disorders | — | — |
| Reaction | System | Interictal State (Period A) | Ictal/Peri-ictal State (Pe… |
|---|---|---|---|
| Complex Partial Seizures | Nervous system disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Somnolence | Nervous system disorders | — | — |
| Generalized tonic-clonic seizure | Nervous system disorders | — | — |
| Seizure | Nervous system disorders | — | — |
| Seizure cluster | Nervous system disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
Most-reported serious reactions: HOSPITALIZATION DUE TO SEIZURE CLUSTER.
Data from ClinicalTrials.gov NCT03179891 adverse events section.
This Phase 2 open-label, two-way study was conducted in adult subjects with epilepsy who were on stable regimens of anti-epileptic drugs (AEDs) and who were admitted to an Epilepsy Monitoring Unit (EMU), General Clinical Research Center (GCRC), or similar facility for evaluation of their seizures. All subjects received a single DBF 12.5 mg dose during the Interictal State and a single DBF 12.5 mg dose during the Ictal/peri-ictal state with at least 14 days washout between the 2 doses.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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