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Migraine pill trial pulled before it began
NCT ID NCT05685225
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study planned to test a combination of naltrexone and acetaminophen for treating migraine attacks. It was designed in two stages: first comparing the combo to each drug alone and placebo, then finding the best dose. However, the trial was withdrawn before any participants were enrolled, so no data was collected.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Naltrexone and acetaminophen combination
- What this could lead to
- If it worked, this could offer a new option for treating migraine attacks without opioids.
- What could go wrong
- The trial was withdrawn before enrolling anyone, so no results exist. It is unclear if the combination is safe or effective.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Started
-
Jan 2025
- Finished
-
Dec 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Ages 18 to 75 years, inclusive. 2. At least 1-year of history of migraine with or without aura as defined by the International Classification of Headache Disorders 3rd edition 17 (ICHD-3). 3. Migraine onset before age 50 years. 4. Read, write, and speak English 5. BMI Higher than 20 and Lower than 34 6. The female subject who is premenopausal or postmenopausal less than one year or have not had surgical sterilization (i.e., tubal ligation, partial or complete hysterectomy) must have a negative urine pregnancy test, be non-lactating, and commit to using two methods of adequate and reliable contraception throughout the study and for 28 days after taking the last dose of the study medication (e.g., barrier with an additional spermicidal, intra- uterine device, hormonal contraception). Male subjects must be surgically sterile (the procedure occurred greater than 6 months before the Screening Visit) or commit to using two different birth control methods during the study and for 28 days after the last dose of the study medication. Exclusion Criteria: 1. Pregnant or nursing women or those planning a pregnancy. 2. Used opioids (including methadone and buprenorphine), barbiturate-containing medications, muscle relaxants, or benzodiazepines within 3 months prior to screening. 3. Used any recreational drugs in the past 3 months. 4. Use of medications to treat headaches more than 10 days per month in the past 3 months or use of any pain medication for other pain syndromes for more than 10 days per month. 5. Uncontrolled cardiovascular or cerebrovascular disease or a history of heart failure, atrial fibrillation, or myocardial infarction. 6. Uncontrolled hypertension (systolic/diastolic blood pressure ˃ 140/90 mmHg) or diabetes. 7. Immediate family members or same household members participating in the study. 8. Site personnel, their friends, and family. 9. Abnormal laboratory or ECG results. 1. Aspartate transaminase (AST/SGOT), alanine transaminase (ALT/SGPT), or alkaline Phosphatase ≥ 1.5 x Upper Limit of Normal (ULN). creatinine ≥ 1.5 x ULN. 2. BBB or intraventricular conduction defect with a QRS duration ≥ 150 msec. ST-T wave abnormalities. 3. Hemoglobin \< 10 g/dL 4. Neutrophil count ≤ 1000/μL 5. Cholesterol ≥ 300 mg/dL 6. Triglycerides ≥ 500 mg/dL Additional exclusion criteria may apply.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Keystone Clinical Research
North Miami, Florida, 33181, United States
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