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NCT03185143 · ClinicalTrials.gov registry record · Phase 2

Low-Dose Naltrexone and Acetaminophen Combination and Sumatriptan in the Acute Treatment of Migraine With Nausea

A Phase 2 study, sponsored by Allodynic Therapeutics.

Completed
Registry status
Phase 2
Development phase
36
Enrollment target

NCT03185143: Completed Phase 2 study, sponsored by Allodynic Therapeutics.

NCT03185143 is a Phase 2 study that has completed, run by Allodynic Therapeutics. The registered enrollment target is 36 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03185143, a Phase 2 study, has completed, sponsored by Allodynic Therapeutics.

COMPLETED
Registry status
Phase 2
Development phase
36 participants
Enrollment target

Study Summary

This proof-of-concept study compares side-by-side low-dose naltrexone and acetaminophen combination to sumatriptan in the acute treatment of migraine.

Primary Outcome

Measured by asking the patients to self-report the current status of their headache pain on a four-point Likert scale (i.e., 0=none, 1=mild, 2=moderate, 3=severe).

Interventions

  • DRUG Placebo
  • DRUG Sumatriptan 100 mg
  • DRUG Naltrexone and Acetaminophen Combination

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2017-06-27
Est. Completion 2018-05-07
Phase Phase 2
Allodynic Therapeutics

5 total trials

What the finished NCT03185143 record still lists

NCT03185143 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT03185143 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03185143 about?

NCT03185143 is a clinical study titled "Low-Dose Naltrexone and Acetaminophen Combination and Sumatriptan in the Acute Treatment of Migraine With Nausea". This proof-of-concept study compares side-by-side low-dose naltrexone and acetaminophen combination to sumatriptan in the acute treatment of migraine.

What is the current status of trial NCT03185143?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2017-06-27. Estimated completion is 2018-05-07.

What interventions are being tested in trial NCT03185143?

The interventions under investigation include: Placebo (DRUG), Sumatriptan 100 mg (DRUG), Naltrexone and Acetaminophen Combination (DRUG).

Who is sponsoring clinical trial NCT03185143?

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

How this trial's enrollment target compares

Where NCT03185143's enrollment target sits among peer trials

36 1496th of 2000 higher than 477 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 NCT03185143, the US trial registry maintained by the National Library of Medicine. NCT03185143 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.