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NCT03179891 · ClinicalTrials.gov registry record · Phase 2

Study of Diazepam Buccal Film Administered in the Interictal and in the Ictal-Periictal States to Adults With Epilepsy

A Phase 2 study, sponsored by Aquestive Therapeutics.

Completed
Registry status
Phase 2
Development phase
35
Enrollment target

NCT03179891 is a Phase 2 study that has completed, run by Aquestive Therapeutics. The registered enrollment target is 35 participants.

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The verdict

NCT03179891, a Phase 2 study, has completed, sponsored by Aquestive Therapeutics.

COMPLETED
Registry status
Phase 2
Development phase
35 participants
Enrollment target

Study Summary

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.

Interventions

  • DRUG Diazepam Buccal Film 12.5 mg

Trial Details

FieldValue
Enrollment Target 35 participants
Start Date 2017-05-25
Est. Completion 2018-12-21
Phase Phase 2

Sponsor

Aquestive Therapeutics

6 total trials

What the Registry Record Tells You About NCT03179891

The ClinicalTrials.gov registry entry for NCT03179891 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Aquestive Therapeutics, which has 6 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Diazepam Buccal Film 12.5 mg is the first listed.

NCT03179891 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03179891 about?

NCT03179891 is a clinical study titled "Study of Diazepam Buccal Film Administered in the Interictal and in the Ictal-Periictal States to Adults With Epilepsy". 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. A...

What is the current status of trial NCT03179891?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 35 participants. The study started on 2017-05-25. Estimated completion is 2018-12-21.

What interventions are being tested in trial NCT03179891?

The interventions under investigation include: Diazepam Buccal Film 12.5 mg (DRUG).

Who is sponsoring clinical trial NCT03179891?

This trial is sponsored by Aquestive Therapeutics, which has 6 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.