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NCT02474407 · ClinicalTrials.gov registry record · Phase 2

Bioavailability, Safety and Tolerability of Diazepam Nasal Spray Versus Diazepam Rectal Gel (Diastat®)

A Phase 2 study, sponsored by Acorda Therapeutics.

Terminated
Registry status
Phase 2
Development phase
78
Enrollment target

NCT02474407: Clinical Trial Phase 2 study, sponsored by Acorda Therapeutics.

NCT02474407 is a Phase 2 study that was terminated before completion, run by Acorda Therapeutics. The registered enrollment target is 78 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02474407, a Phase 2 study, was terminated before completion, sponsored by Acorda Therapeutics.

TERMINATED
Registry status
Phase 2
Development phase
78 participants
Enrollment target

Study Summary

This is a multi-center, open-label, crossover, pharmacokinetic, bio-availability study involving adolescents and adults with refractory (drug-resistant) epilepsy. Cohort 1 comprises the subjects used to determine the relative bioavailability of DZNS versus DRG (Diastat)

Primary Outcome

Relative bioavailability based on area under time plasma concentration curve.

Interventions

  • DRUG diazepam nasal spray
  • DRUG diazepam rectal gel

Trial Details

FieldValue
Enrollment Target 78 participants
Start Date 2015-06
Est. Completion 2016-07
Phase Phase 2
Acorda Therapeutics

36 total trials

Why NCT02474407 stopped before completion

NCT02474407 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% lower).

The record links to 0 conditions, and to 2 interventions - of which diazepam nasal spray is the first listed.

NCT02474407 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02474407 about?

NCT02474407 is a clinical study titled "Bioavailability, Safety and Tolerability of Diazepam Nasal Spray Versus Diazepam Rectal Gel (Diastat®)". This is a multi-center, open-label, crossover, pharmacokinetic, bio-availability study involving adolescents and adults with refractory (drug-resistant) epilepsy. Cohort 1 comprises the subjects used to determine the relative bioavailability of DZNS versus DRG (Diastat)

What is the current status of trial NCT02474407?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 78 participants. The study started on 2015-06. Estimated completion is 2016-07.

What interventions are being tested in trial NCT02474407?

The interventions under investigation include: diazepam nasal spray (DRUG), diazepam rectal gel (DRUG).

Who is sponsoring clinical trial NCT02474407?

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 NCT02474407's enrollment target sits among peer trials

78 884th of 2000 higher than 1,110 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 NCT02474407, the US trial registry maintained by the National Library of Medicine. NCT02474407 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.