Low-Dose Naltrexone and Acetaminophen Combination and Its Components in the Acute Treatment of Migraine (ANODYNE-1)

April 11, 2021 updated by: Allodynic Therapeutics, LLC

A Clinical Trial to Assess a Single Dose of Low-Dose Naltrexone and Acetaminophen Combination and Its Components in the Acute Treatment of Migraine

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • North Miami, Florida, United States, 33181
        • Annette C. Toledano MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female 18 years of age or older.
  2. History of migraine with or without aura according to the International Classification of Headache Disorders (ICHD)-3rd edition (beta version) for at least one-year with first migraine prior to age 50.
  3. Migraine-associated nausea with ≥half of migraine attacks.
  4. 2 - 8 migraines per month in each of the previous 3 months.
  5. The patient is able to complete study questionnaires, comply with the study requirements and restrictions, and willing to provide written informed consent and authorize HIPAA.
  6. The female patient who is premenopausal or postmenopausal less than 1 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 adequate and reliable contraception throughout the study (e.g., barrier with additional spermicidal, intra-uterine device, hormonal contraception). The male patient must be surgically sterile or commit to the use of 2 different methods of birth control during the study and for 28 days after taking the study drug.

Exclusion Criteria:

  1. The patient in the opinion of the investigator, may have medication-overuse headache pain (as defined by ICHD - 3 beta criteria for medication-overuse headache), (analgesic, opioid, ergotamine or triptan overuse) during the 3 months preceding screening.
  2. The patient in the opinion of the investigator has chronic migraine (as defined by ICHD - 3 beta criteria for chronic migraine).
  3. History of cluster headache or neurologically complicated migraine (hemiplegic, basilar, retinal, ophthalmoplegic migraine).
  4. Initiation or change in medications with possible migraine prophylactic effects during 3 months before inclusion into the trial (E.g., calcium channel blockers, tricyclic antidepressants, beta-blockers, selective serotonin re-uptake inhibitors (SSRIs), serotonin-norepinephrine re-uptake inhibitors (SNRIs), or Botox).
  5. Any concurrent medical or psychiatric condition, this includes, but is not limited to chronic unstable debilitating diseases, significant renal or hepatic impairment.
  6. A history within the previous 3 years of abuse of any drug, prescription, illicit, or alcohol.
  7. The Female patient is pregnant or breast-feeding. The Male patient is not practicing 2 different methods of birth control with their partner during the study, and for 28 days after the investigational drug last dose or will not remain abstinent during the study, and for 28 days after the last dose.
  8. Use of opiates or barbiturates more than 3 days per month.
  9. Known-hypersensitivity reaction to any of the components of the investigational drug.
  10. Consumption of analgesic medication for other conditions on a regular basis, (nonsteroidal anti-inflammatory drugs, or acetaminophen, or muscle relaxants).
  11. Use of emergency care treatment more than 3 times in the previous 6 months.
  12. Participation in another study with an investigational drug within 30 days prior to randomization and/or a plan to participate during the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Naltrexone and Acetaminophen
Patients take one capsule containing naltrexone and one capsule containing acetaminophen together for a qualifying migraine
Drug: Naltrexone and Acetaminophen
Naltrexone plus acetaminophen
Experimental: Naltrexon/Acetaminophen-High Capsules
Patient take one capsule containing naltrexone (high dose) and one capsule containing acetaminophen together for a qualifying migraine
Drug: Naltrexone and Acetaminophen-High Dose
Naltrexon (high dose) plus acetaminophen
Active Comparator: Naltrexone Alone Capsules
Patient take one capsule containing naltrexone and one capsule containing placebo together for a qualifying migraine
Drug: Naltrexone Alone (regular dose)
Naltrexone Alone plus Placebo
Active Comparator: Acetaminophen Alone Capsules
Patient take one capsule containing naltrexone and one capsule containing placebo together for a qualifying migraine
Drug: Acetaminophen Alone
Acetaminophen Alone plus Placebo
Placebo Comparator: Placebo Capsules
Patient take two capsule containing placebo together for a qualifying migraine
Drug: Matching Placebo
Two Placebo capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
% of patients reporting no headache pain.
Time Frame: 2 hours post-dose
Self-reported headache pain on a four-point Likert scale.
2 hours post-dose
% of patients having absence of most bothersome migraine-associated symptom (MBS).
Time Frame: 2 hours post-dose
MBS was prospectively identified at baseline. Self-reported MBS as present or absent.
2 hours post-dose
% of patients who have "sustained pain freedom"
Time Frame: 24-hour post-dose.
Defined as having no headache pain at 2 hours after dose, with no use of rescue medication and no relapse of headache pain within 24 hours after administration of the investigational drug.
24-hour post-dose.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
% of patients having absence of nausea, photophobia, phonophobia, and neck/shoulder pain
Time Frame: 24-hour post-dose.
Self-reported the current status of their associated symptom as present or absent.
24-hour post-dose.
% of patients who used rescue medications
Time Frame: 2-24 hours
2-24 hours
% of patients who had headache pain relapse.
Time Frame: 2-48 hours
Defined as the return of headache of any severity within 48 hours after administration of the investigational drug, when the patient was pain-free at 2 hours after the administration of the investigational drug.
2-48 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
% of patients who experienced adverse events
Time Frame: 48 hours
treatment related Adverse Events
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allodynic Therapeutics, LLC

Investigators

  • Study Director: Annette C Toledano, M.D., Allodynic Therapeutics, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 18, 2017

Primary Completion (Actual)

February 8, 2018

Study Completion (Actual)

February 8, 2018

Study Registration Dates

First Submitted

February 17, 2017

First Submitted That Met QC Criteria

February 18, 2017

First Posted (Actual)

February 23, 2017

Study Record Updates

Last Update Posted (Actual)

April 14, 2021

Last Update Submitted That Met QC Criteria

April 11, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANODYNE-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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