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Low-Dose Naltrexone and Acetaminophen Combination and Sumatriptan in the Acute Treatment of Migraine With Nausea

NCT03185143 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2021-04-14

No results posted yet for this study

Summary

This proof-of-concept study compares side-by-side low-dose naltrexone and acetaminophen combination to sumatriptan in the acute treatment of migraine.

Conditions

  • Migraine With and Without Aura

Interventions

DRUG

Naltrexone and Acetaminophen Combination

Treat a single Qualified Migraine attack.

DRUG

Sumatriptan 100 mg

One capsule contains Sumatriptan 100 mg and one capsule contains a sham for component B taken together to treat a single Qualified Migraine attack.

DRUG

Placebo

One capsule contains a sham for component A and one capsule contains a sham for component B taken together to treat a single Qualified Migraine attack.

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
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-27
Primary Completion
2018-05-07
Completion
2018-05-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

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 NCT03185143 on ClinicalTrials.gov