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NCT02856802 · ClinicalTrials.gov registry record · Phase 2

An Efficacy and Safety Study of DFN-02 (Sumatriptan Nasal Spray 10 mg)

A Phase 2 study, sponsored by Upsher-Smith Laboratories.

Completed
Registry status
Phase 2
Development phase
107
Enrollment target

NCT02856802: Completed Phase 2 study, sponsored by Upsher-Smith Laboratories.

NCT02856802 is a Phase 2 study that has completed, run by Upsher-Smith Laboratories. The registered enrollment target is 107 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02856802, a Phase 2 study, has completed, sponsored by Upsher-Smith Laboratories.

COMPLETED
Registry status
Phase 2
Development phase
107 participants
Enrollment target

Study Summary

A safety and efficacy study of DFN-02 (Sumatriptan Nasal Spray 10 mg), being conducted at multiple centers in the United States.

Primary Outcome

Freedom from headache pain at 2 hours after the first dose of study medication taken within one hour after experiencing a migraine attack of moderate to severe headache pain during the DB1 treatment period, e.g., headache pain rating of moderate \[Grade 2\] or severe \[Grade 3\] predose and reduced to none \[Grade 0\] postdose). Mild headache pain was recorded as Grade 1. If the subject was not able to use study medication for the first migraine after randomization, they were instructed to use t

Interventions

  • DRUG Sumatriptan 10 mg Nasal Spray
  • OTHER Sumatriptan Placebo Nasal Spray

Trial Details

FieldValue
Enrollment Target 107 participants
Start Date 2016-07-11
Est. Completion 2017-02-10
Phase Phase 2
Upsher-Smith Laboratories

5 total trials

What the finished NCT02856802 record still lists

NCT02856802 is an interventional study that assigns participants to a tested intervention. The registered 107 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% lower).

The record links to 0 conditions, and to 2 interventions - of which Sumatriptan 10 mg Nasal Spray is the first listed.

NCT02856802 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02856802 about?

NCT02856802 is a clinical study titled "An Efficacy and Safety Study of DFN-02 (Sumatriptan Nasal Spray 10 mg)". A safety and efficacy study of DFN-02 (Sumatriptan Nasal Spray 10 mg), being conducted at multiple centers in the United States.

What is the current status of trial NCT02856802?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 107 participants. The study started on 2016-07-11. Estimated completion is 2017-02-10.

What interventions are being tested in trial NCT02856802?

The interventions under investigation include: Sumatriptan 10 mg Nasal Spray (DRUG), Sumatriptan Placebo Nasal Spray (OTHER).

Who is sponsoring clinical trial NCT02856802?

This trial is sponsored by Upsher-Smith Laboratories, which has 5 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02856802's enrollment target sits among peer trials

107 646th of 2000 higher than 1,353 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 NCT02856802, the US trial registry maintained by the National Library of Medicine. NCT02856802 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.