Trials / Completed
CompletedNCT06245902
An Acute Migraine Factorial Study
A Clinical Trial to Assess a Single Dose of Low-Dose Naltrexone and Acetaminophen Combination and Its Components in the Acute Treatment of Migraine
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 92 (actual)
- Sponsor
- Allodynic Therapeutics, Inc · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Naltrexone and Acetaminophen | Naltrexone plus acetaminophen |
| DRUG | Naltrexone and Acetaminophen-High Dose | Naltrexon (high dose) plus acetaminophen |
| DRUG | Naltrexone Alone (regular dose) | Naltrexone Alone plus Placebo |
| DRUG | Acetaminophen Alone | Acetaminophen Alone plus Placebo |
| DRUG | Matching Placebo | Two Placebo capsules |
Timeline
- Start date
- 2017-02-18
- Primary completion
- 2018-02-08
- Completion
- 2018-02-08
- First posted
- 2024-02-07
- Last updated
- 2024-02-07
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06245902. Inclusion in this directory is not an endorsement.