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

NCT03185143 | Completed Phase 2 FDA Drug

• 1 other identifier: ANODYNE-2
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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 hours

• 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.

  2 hours

Secondary Outcomes (5)

• The proportion of patients having the absence of nausea, photophobia, phonophobia, and neck/shoulder pain at 2 hours.

  24 and 48 hours

• The proportion of patients who used rescue medications within 24 hours.

  24 hours

• The proportion of patients who are "sustained pain-free" at 24-hours and 48-hours.

  48 hours.

• The proportion of patients who had headache pain relapse within 48 hours

  48 hours

• The proportion of patients who experienced adverse events

  48 hours

Study Arms (3)

Naltrexone and Acetaminophen Combination

EXPERIMENTAL

Drug: Naltrexone and Acetaminophen Combination

Sumatriptan 100 mg

ACTIVE COMPARATOR

Drug: Sumatriptan 100 mg

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Naltrexone and Acetaminophen Combination DRUG

Treat a single Qualified Migraine attack.

Naltrexone and Acetaminophen Combination

Sumatriptan 100 mg DRUG

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

Sumatriptan 100 mg

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female 18 to 65 years of age.
• 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.
• Migraine-associated nausea with ≥half the migraine attacks.
• migraines per month in each of the previous 3 months.
• 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.
• 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).

You may not qualify if:

• 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.
• 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.
• History of cluster headaches or neurologically complicated migraine (hemiplegic, basilar, retinal, ophthalmoplegic).
• Use of opiates or barbiturates more than 3 days per month.
• Any concurrent medical or psychiatric condition, this includes, but is not limited to chronic unstable debilitating diseases, significant renal or hepatic impairment.
• The patient has a history within the previous 3 years of abuse of any drug, prescription, illicit, or alcohol.
• 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.
• The patient has known-hypersensitivity reaction to any of the components of the investigational drug.
• Consumption of analgesic medication or muscle relaxants (including all benzodiazepines) for other conditions on a regular basis.
• The patient has used emergency care treatment more than 3 times in the previous 6 months.
• 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.
• 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.
• Uncontrolled hypertension (sitting \>160 mmHg systolic pressure or \>95mmHg diastolic pressure).
• The patient, in the investigator's opinion, is likely to have unrecognized cardiovascular or cerebrovascular disease.
• History of epilepsy. Allergy to sulfonamides.

Sponsors & Collaborators

• Allodynic Therapeutics, Inc: lead

Study Sites (1)

Annette C. Toledano, M.D.

North Miami, Florida, 33181, United States

Location

MeSH Terms

Interventions

Naltrexone; Sumatriptan

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring

Study Officials

• Annette C. Toledano, M.D.

  Allodynic Therapeutics, Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2017
• First Posted: June 14, 2017
• Study Start: June 27, 2017
• Primary Completion: May 7, 2018
• Study Completion: May 7, 2018
• Last Updated: April 14, 2021

Record last verified: 2018-05

Locations

US (1)