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

Recruitment Status
COMPLETED
(See Contacts and Locations)Verified April 2018 by Allodynic Therapeutics, Inc
Sponsor
Allodynic Therapeutics, Inc
Information Provided by (Responsible Party)
Allodynic Therapeutics, Inc
Clinicaltrials.gov Identifier
NCT03185143
Other Study ID Numbers:
ANODYNE-2
First Submitted
June 7, 2017
First Posted
June 13, 2017
Last Update Posted
April 13, 2021
Last Verified
April 2018

ClinicalTrials.gov processed this data on April 2021. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

The study consists of a screening visit, outpatient treatment of a moderate or severe migraine attack with a single dose of the study drug within 8 weeks, and End-of-Study Visit 2-7 days after dosing.

Condition or DiseaseIntervention/Treatment
Migraine With and Without Aura
Drug: Naltrexone and Acetaminophen CombinationDrug: Sumatriptan 100 mgDrug: Placebo

Study Design

Study TypeInterventional
Actual Enrollment36 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleRandomized, Double-Blind, and Placebo-Controlled Study to Assess a Single Dose of Low-Dose Naltrexone and Acetaminophen Combination Versus Sumatriptan in the Acute Treatment of Migraine With Nausea
Study Start DateJune 26, 2017
Actual Primary Completion DateMay 6, 2018
Actual Study Completion DateMay 6, 2018

Groups and Cohorts

Group/CohortIntervention/Treatment
Naltrexone and Acetaminophen Combination
Drug: Naltrexone and Acetaminophen Combination
Treat a single Qualified Migraine attack.
Sumatriptan 100 mg
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.
Placebo
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.

Outcome Measures

Primary Outcome Measures
  1. The proportion of patients having no headache pain at 2 hours.
    Measured by asking the patients to self-report the current status of their headache pain on a four-point Likert scale (i.e., 0=none, 1=mild, 2=moderate, 3=severe).
  2. The proportion of patients having the absence of the most bothersome migraine-associated symptom at 2 hours.
    The most bothersome migraine-associated symptom is prospectively identified at baseline. It is measured by asking the patients to self-report the current status of their associated symptom as present or absent.
Secondary Outcome Measures
  1. The proportion of patients having the absence of nausea, photophobia, phonophobia, and neck/shoulder pain at 2 hours.
    Measured by asking the patients to self-report the current status of their associated symptoms as present or absent.
  2. The proportion of patients who used rescue medications within 24 hours.
  3. The proportion of patients who are "sustained pain-free" at 24-hours and 48-hours.
    Defined as having no headache pain at 2 hours after the dose, with no use of rescue medication and no relapse of headache pain within 24 hours (24-hour sustained pain-free) or 48 hours (48-hour sustained pain-free) after administration of the investigational drug.
  4. The proportion of patients who had headache pain relapse within 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.
  5. The proportion of patients who experienced adverse events

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
1. Male or female 18 to 65 years of age. 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 the 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 2 methods of adequate and reliable contraception throughout the study and for 28 days after taking the last dose of the study drug (e.g., barrier with additional spermicidal, intra-uterine device, hormonal contraception). Male patients must be surgically sterile or commit to the use of 2 different methods of birth control during the study and for 28 days after the study.ice, hormonal contraception).
Exclusion Criteria
1. The patient in the opinion of the investigator may have medication-overuse headaches (as defined by ICHD - 3 beta criteria for medication-overuse headache) during the preceding 3 months. 2. The patient in the opinion of the investigator has chronic migraine (as defined by ICHD - 3 beta criteria for chronic migraine) during the preceding 3 months. 3. History of cluster headaches or neurologically complicated migraine (hemiplegic, basilar, retinal, ophthalmoplegic). 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, or Botox). 5. Use of opiates or barbiturates more than 3 days per month. 6. Any concurrent medical or psychiatric condition, this includes, but is not limited to chronic unstable debilitating diseases, significant renal or hepatic impairment. 7. The patient has a history within the previous 3 years of abuse of any drug, prescription, illicit, or alcohol. 8. 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. 9. The patient has known-hypersensitivity reaction to any of the components of the investigational drug. 10. Consumption of analgesic medication or muscle relaxants (including all benzodiazepines) for other conditions on a regular basis. 11. The patient has used emergency care treatment more than 3 times in the previous 6 months. 12. The patient has participated in another study with an investigational drug within 30 days prior to randomization and/or plan to participate during the study. 13. The patient has a history of congenital heart disease, cardiac arrhythmias, or cardiovascular disease, e.g., ischemic heart disease (e.g., stable angina pectoris, unstable angina, vasospastic angina, myocardial infarction or silent myocardial ischemia), cerebrovascular syndromes (e.g., strokes of any type or transient ischemic attacks), peripheral vascular disease, ischemic bowel disease, or Raynaud syndrome. 14. Uncontrolled hypertension (sitting \>160 mmHg systolic pressure or \>95mmHg diastolic pressure). 15. The patient, in the investigator's opinion, is likely to have unrecognized cardiovascular or cerebrovascular disease. 16. History of epilepsy. Allergy to sulfonamides. 17. Consumption of monoamine oxidase inhibitor (MAOI) drug, tricyclic antidepressant, selective serotonin reuptake inhibitor (SSRI) or Serotonin Noradrenaline Reuptake Inhibitor (SNRI).

Contacts and Locations

Sponsors and CollaboratorsAllodynic Therapeutics, Inc
Locations
Annette C. Toledano, M.D. | North Miami Florida, United States, 33181
Investigators
Principal Investigator: Annette C. Toledano, M.D., Allodynic Therapeutics, Inc