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NCT03061734 · ClinicalTrials.gov registry record · Phase 2
Low-Dose Naltrexone and Acetaminophen Combination and Its Components in the Acute Treatment of Migraine
A Phase 2 study, sponsored by Allodynic Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 92
- Enrollment target
NCT03061734: Completed Phase 2 study, sponsored by Allodynic Therapeutics.
NCT03061734 is a Phase 2 study that has completed, run by Allodynic Therapeutics. The registered enrollment target is 92 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (31% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03061734, a Phase 2 study, has completed, sponsored by Allodynic Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 92 participants
- Enrollment target
Study Summary
The study consists of a screening visit, out-patient treatment of a moderate or severe migraine attack with a single dose of the study medication within 8 weeks, and End-of-Study Visit 2-7 days after dosing.
Primary Outcome
Self-reported headache pain on a four-point Likert scale.
Interventions
- DRUG Matching Placebo
- DRUG Naltrexone and Acetaminophen
- DRUG Naltrexone and Acetaminophen-High Dose
- DRUG Naltrexone Alone (regular dose)
- DRUG Acetaminophen Alone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2017-02-18 |
| Est. Completion | 2018-02-08 |
| Phase | Phase 2 |
What the finished NCT03061734 record still lists
NCT03061734 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (31% lower).
The record links to 0 conditions, and to 5 interventions - of which Matching Placebo is the first listed.
NCT03061734 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03061734 about?
NCT03061734 is a clinical study titled "Low-Dose Naltrexone and Acetaminophen Combination and Its Components in the Acute Treatment of Migraine". The study consists of a screening visit, out-patient treatment of a moderate or severe migraine attack with a single dose of the study medication within 8 weeks, and End-of-Study Visit 2-7 days after dosing.
What is the current status of trial NCT03061734?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 92 participants. The study started on 2017-02-18. Estimated completion is 2018-02-08.
What interventions are being tested in trial NCT03061734?
The interventions under investigation include: Matching Placebo (DRUG), Naltrexone and Acetaminophen (DRUG), Naltrexone and Acetaminophen-High Dose (DRUG), Naltrexone Alone (regular dose) (DRUG), Acetaminophen Alone (DRUG).
Who is sponsoring clinical trial NCT03061734?
This trial is sponsored by Allodynic Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03061734's enrollment target sits among peer trials
92 767th of 2000 higher than 1,230 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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