Trial · NCT05685225
Single-Site Study of Naltrexone/Acetaminophen for the Acute Treatment of Migraine: A Phase 2 Randomized Trial
NCT05685225, Phase 2, Withdrawn, Allodynic Therapeutics, Inc
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Single-Site Study of Naltrexone/Acetaminophen for the Acute Treatment of Migraine: A Phase 2 Randomized Trial. Trials, record NCT05685225. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05685225
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Single-Site Study of Naltrexone/Acetaminophen for the Acute Treatment of Migraine: A Phase 2 Randomized Trial
- NCT number
- NCT05685225
- Status
- Withdrawn
- Phases
- Phase 2
- Enrollment
- 0 participants, actual
- Lead sponsor
- Allodynic Therapeutics, Inc
- Conditions
- Migraine
- Interventions
Stage 1: Naltrexone/Acetaminophen, Stage 1: Naltrexone, Stage 1: Acetaminophen, Stage1: Placebo, Stage 2: Naltrxone/Acetaminophen high dose, Stage 2: Naltrexone/Acetaminophen medium dose, Stage 2: Naltrxone/Acetaminophen low dose, Stage 2: Placebo
- First posted
- 2023-01-17
- Last updated
- 2025-12-08
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of subjects with acute migraine who achieved freedom from pain after dosing | 2 hours after dosing | Freedom from pain is defined as the absence of headache pain from moderate or severe pain at baseline, without the use of rescue medication. The pain is measured on a 4-point scale, with 0 indicating no pain, 1 for mild pain, 2 for moderate pain, and 3 for severe pain. |
| Primary | Proportion of subjects with acute migraine who achieved freedom from migraine's Most Bothersome Symptoms (MBS) after dosing | 2 hours after dosing | MBS freedom is defined as the absence of the identified Most Bothersome Symptom (MBS), which can be nausea, photophobia, or phonophobia. The MBS is measured on a binary scale, either absent or present. |
| Secondary | Proportion of subjects with acute migraine who achieved pain relief | 2 hours after dosing | Pain relief is defined as a reduction in headache pain severity from moderate or severe to mild or no headache pain. |
| Secondary | Proportion of subjects with acute migraine who achieved freedom from photophobia | 2 hours after dosing | Freedom from photophobia is defined as absence of photophobia |
| Secondary | Proportion of subjects with acute migraine who achieved freedom from phonophobia | 2 hours after dosing | Freedom from phonophobia is defined as absence of phonophobia |
| Secondary | Proportion of subjects with acute migraine who achieved freedom from nausea | 2 hours after dosing | Freedom from nausea is defined as absence of nausea |
| Secondary | Proportion of subjects with acute migraine who achieved sustained pain relief from 2 to 24 hours | 2 to 24 hours | Sustained pain relief is defined as the reduction of headache pain severity from moderate or severe intensity to mild without the use of rescue medication. |
| Secondary | The proportion of subjects with acute migraine who achieved sustained pain freedom from 2 to 24 hours | 2 to 24 hours | Sustained pain freedom is defined as the absence of any headache pain of any intensity without the use of rescue medication. |
| Secondary | Functional disability at 2 hours | 2 hours after dosing | Functional disability refers to the inability to perform activities of daily living or work tasks to a normal level due to physical, mental, or sensory impairments. It is measured on a scale of 0 to 3, where 0 indicates normal function and 3 indicates the need for bedrest due to severe impairment. |
| Secondary | Functional disability at 24 hours | 24 hours after dosing | Functional disability refers to the inability to perform activities of daily living or work tasks to a normal level due to physical, mental, or sensory impairments. It is measured on a scale of 0 to 3, where 0 indicates normal function and 3 indicates the need for bedrest due to severe impairment. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers43
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05685225
GET https://conductscience.org/api/trials/v1/NCT05685225/papers?page=2