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Low-Dose Naltrexone and Acetaminophen Combination and Its Components in the Acute Treatment of Migraine

NCT03061734 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2021-04-14

No results posted yet for this 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.

Conditions

  • Migraine With or Without Aura

Interventions

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

Sponsors & Collaborators

  • Allodynic Therapeutics, Inc

    lead INDUSTRY

Principal Investigators

  • Annette C Toledano, M.D. · Allodynic Therapeutics, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-18
Primary Completion
2018-02-08
Completion
2018-02-08
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03061734 on ClinicalTrials.gov