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NCT04940390 · ClinicalTrials.gov registry record · Phase 3

A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Assess STS101 in the Acute Treatment of Migraine

A Phase 3 study, sponsored by Satsuma Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
1,591
Enrollment target

NCT04940390: Completed Phase 3 study, sponsored by Satsuma Pharmaceuticals.

NCT04940390 is a Phase 3 study that has completed, run by Satsuma Pharmaceuticals. The registered enrollment target is 1,591 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (106% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04940390, a Phase 3 study, has completed, sponsored by Satsuma Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
1,591 participants
Enrollment target

Study Summary

Study STS101-007 is a randomized, double-blind, parallel group, placebo-controlled, multicenter study to evaluate the efficacy, safety, and tolerability of single doses of STS101 (dihydroergotamine nasal powder) in the acute treatment of migraine.

Primary Outcome

The subject's rating was documented on a four-point scale from no pain (= 0), mild pain (= 1), moderate pain (= 2) to severe pain (= 3). Pain freedom means the pain went from moderate (2) or severe (3) to no pain (0).

Interventions

  • DRUG Placebo
  • DRUG Dihydroergotamine

Trial Details

FieldValue
Enrollment Target 1,591 participants
Start Date 2021-06-30
Est. Completion 2022-10-26
Phase Phase 3
Satsuma Pharmaceuticals

5 total trials

What the finished NCT04940390 record still lists

NCT04940390 is an interventional study that assigns participants to a tested intervention. Its 1,591 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (106% higher).

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

NCT04940390 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04940390 about?

NCT04940390 is a clinical study titled "A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Assess STS101 in the Acute Treatment of Migraine". Study STS101-007 is a randomized, double-blind, parallel group, placebo-controlled, multicenter study to evaluate the efficacy, safety, and tolerability of single doses of STS101 (dihydroergotamine nasal powder) in the acute treatment of migraine.

What is the current status of trial NCT04940390?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,591 participants. The study started on 2021-06-30. Estimated completion is 2022-10-26.

What interventions are being tested in trial NCT04940390?

The interventions under investigation include: Placebo (DRUG), Dihydroergotamine (DRUG).

Who is sponsoring clinical trial NCT04940390?

This trial is sponsored by Satsuma Pharmaceuticals, which has 5 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04940390's enrollment target sits among peer trials

1,591 147th of 2000 higher than 1,854 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT04940390, the US trial registry maintained by the National Library of Medicine. NCT04940390 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.