- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03185143
Low-Dose Naltrexone and Acetaminophen Combination and Sumatriptan in the Acute Treatment of Migraine With Nausea
April 11, 2021 updated by: Allodynic Therapeutics, LLC
Randomized, 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
This proof-of-concept study compares side-by-side low-dose naltrexone and acetaminophen combination to sumatriptan in the acute treatment of migraine.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Phase 2
- Phase 3
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
-
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Florida
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North Miami, Florida, United States, 33181
- Annette C. Toledano, M.D.
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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 to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
- 2 - 8 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).
Exclusion Criteria:
- 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).
- 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).
- 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.
- Consumption of monoamine oxidase inhibitor (MAOI) drug, tricyclic antidepressant, selective serotonin reuptake inhibitor (SSRI) or Serotonin Noradrenaline Reuptake Inhibitor (SNRI).
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 |
---|---|
Placebo Comparator: Placebo
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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.
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Experimental: Naltrexone and Acetaminophen Combination
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Treat a single Qualified Migraine attack.
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Active Comparator: Sumatriptan 100 mg
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One capsule contains Sumatriptan 100 mg and one capsule contains a sham for component B taken together to treat a single Qualified Migraine attack.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The proportion of patients having no headache pain at 2 hours.
Time Frame: 2 hours
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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).
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2 hours
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The proportion of patients having the absence of the most bothersome migraine-associated symptom at 2 hours.
Time Frame: 2 hours
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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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The proportion of patients having the absence of nausea, photophobia, phonophobia, and neck/shoulder pain at 2 hours.
Time Frame: 24 and 48 hours
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Measured by asking the patients to self-report the current status of their associated symptoms as present or absent.
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24 and 48 hours
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The proportion of patients who used rescue medications within 24 hours.
Time Frame: 24 hours
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24 hours
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The proportion of patients who are "sustained pain-free" at 24-hours and 48-hours.
Time Frame: 48 hours.
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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.
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48 hours.
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The proportion of patients who had headache pain relapse within 48 hours
Time Frame: 48 hours
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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.
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48 hours
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The proportion of patients who experienced adverse events
Time Frame: 48 hours
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48 hours
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Annette C. Toledano, M.D., Allodynic Therapeutics, LLC
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)
June 27, 2017
Primary Completion (Actual)
May 7, 2018
Study Completion (Actual)
May 7, 2018
Study Registration Dates
First Submitted
June 8, 2017
First Submitted That Met QC Criteria
June 9, 2017
First Posted (Actual)
June 14, 2017
Study Record Updates
Last Update Posted (Actual)
April 14, 2021
Last Update Submitted That Met QC Criteria
April 11, 2021
Last Verified
May 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Headache Disorders, Primary
- Headache Disorders
- Migraine Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Antipyretics
- Serotonin Agents
- Serotonin 5-HT1 Receptor Agonists
- Serotonin Receptor Agonists
- Narcotic Antagonists
- Alcohol Deterrents
- Vasoconstrictor Agents
- Naltrexone
- Acetaminophen
- Sumatriptan
Other Study ID Numbers
- ANODYNE-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
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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