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NCT03194555 · ClinicalTrials.gov registry record · Phase 2
The Preventive Treatment of Migraine With Low-Dose Naltrexone and Acetaminophen Combination
A Phase 2 study of Migraine With or Without Aura, sponsored by Allodynic Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT03194555: Completed Phase 2 study of Migraine With or Without Aura, sponsored by Allodynic Therapeutics.
NCT03194555 is a Phase 2 study of Migraine With or Without Aura that has completed, run by Allodynic Therapeutics. The registered enrollment target is 12 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03194555, a Phase 2 study of Migraine With or Without Aura, has completed, sponsored by Allodynic Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
The Preventive Treatment of Migraine with Low-Dose Naltrexone and Acetaminophen Combination: A Small, Randomized, Double-Blind, and Placebo-Controlled Clinical Trial with an Open-Label Extension for None-Responders
Primary Outcome
Migraine with or without aura is defined according to the International Classification of Headache Disorders (ICHD)-3rd edition (beta version). Migraine headaches must be moderate or severe and lasting ≥30 minutes. When the patient falls asleep during migraine and wakes up without it, duration of the attack is reckoned until the time of awakening).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Low-Dose Naltrexone and Acetaminophen Combination
Study Locations (1)
Florida
- Annette Toledano, M.D. - North Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2017-08-25 |
| Est. Completion | 2018-07-28 |
| Phase | Phase 2 |
What the finished NCT03194555 record still lists
NCT03194555 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Migraine With or Without Aura appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03194555 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT03194555 about?
NCT03194555 is a clinical study titled "The Preventive Treatment of Migraine With Low-Dose Naltrexone and Acetaminophen Combination". The Preventive Treatment of Migraine with Low-Dose Naltrexone and Acetaminophen Combination: A Small, Randomized, Double-Blind, and Placebo-Controlled Clinical Trial with an Open-Label Extension for None-Responders
What is the current status of trial NCT03194555?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2017-08-25. Estimated completion is 2018-07-28.
What conditions does trial NCT03194555 study?
This clinical trial studies the following conditions: Migraine With or Without Aura.
What interventions are being tested in trial NCT03194555?
The interventions under investigation include: Placebo (DRUG), Low-Dose Naltrexone and Acetaminophen Combination (DRUG).
Who is sponsoring clinical trial NCT03194555?
This trial is sponsored by Allodynic Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03194555 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03194555's enrollment target sits among peer trials
12 1948th of 2000 higher than 34 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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