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NCT01417078 · ClinicalTrials.gov registry record · Phase 2

A Pharmacokinetic Study of a Single-Dose of Diazepam Nasal Spray in Adult Epileptic Patients Experiencing a Seizure Episode

A Phase 2 study, sponsored by Acorda Therapeutics.

Completed
Registry status
Phase 2
Development phase
31
Enrollment target

NCT01417078: Completed Phase 2 study, sponsored by Acorda Therapeutics.

NCT01417078 is a Phase 2 study that has completed, run by Acorda Therapeutics. The registered enrollment target is 31 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01417078, a Phase 2 study, has completed, sponsored by Acorda Therapeutics.

COMPLETED
Registry status
Phase 2
Development phase
31 participants
Enrollment target

Study Summary

The purpose of this study is to determine the pharmacokinetics of Diazepam Nasal Spray following a single dose in epileptic patients experiencing a seizure episode.

Primary Outcome

Summary of Dose-Adjusted Diazepam and Nordiazepam PK parameter Cmax. The mean Cmax value was adjusted to a 20 mg dose.

Interventions

  • DRUG Diazepam

Trial Details

FieldValue
Enrollment Target 31 participants
Start Date 2011-09
Est. Completion 2013-03
Phase Phase 2
Acorda Therapeutics

36 total trials

What the finished NCT01417078 record still lists

NCT01417078 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).

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

NCT01417078 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01417078 about?

NCT01417078 is a clinical study titled "A Pharmacokinetic Study of a Single-Dose of Diazepam Nasal Spray in Adult Epileptic Patients Experiencing a Seizure Episode". The purpose of this study is to determine the pharmacokinetics of Diazepam Nasal Spray following a single dose in epileptic patients experiencing a seizure episode.

What is the current status of trial NCT01417078?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 31 participants. The study started on 2011-09. Estimated completion is 2013-03.

What interventions are being tested in trial NCT01417078?

The interventions under investigation include: Diazepam (DRUG).

Who is sponsoring clinical trial NCT01417078?

This trial is sponsored by Acorda Therapeutics, which has 36 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01417078's enrollment target sits among peer trials

31 1578th of 2000 higher than 419 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01417078, the US trial registry maintained by the National Library of Medicine. NCT01417078 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.