Migraine With and Without AuraPhase 2/3NCT03185143
Low-Dose Naltrexone and Acetaminophen Combination and Sumatriptan in the Acute Treatment of Migraine With Nausea
A Phase 2/3 study testing Naltrexone and Acetaminophen Combination and Sumatriptan 100 mg in people with Migraine With and Without Aura, run by Allodynic Therapeutics, Inc at 1 site in United States.
Trial summary
This proof-of-concept study compares side-by-side low-dose naltrexone and acetaminophen combination to sumatriptan in the acute treatment of migraine. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine With and Without Aura
- What is being tested?
- Naltrexone and Acetaminophen Combination and Sumatriptan 100 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jun 2017to 7 May 2018
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 17Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Annette C. Toledano, M.D.
North Miami, Florida, 33181
About this study
Official title: 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.
Read the 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.
- Conditions
- Migraine With and Without Aura
- Being tested
- Naltrexone and Acetaminophen Combination, Sumatriptan 100 mg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naltrexone and Acetaminophen CombinationDrug
Treat a single Qualified Migraine attack.
Sumatriptan 100 mgDrug
One capsule contains Sumatriptan 100 mg and one capsule contains a sham for component B taken together to treat a single Qualified Migraine attack.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Naltrexone and Acetaminophen Combination | Experimental | Not described Receives: Drug: Naltrexone and Acetaminophen Combination |
| Sumatriptan 100 mg | Active comparator | Not described Receives: Drug: Sumatriptan 100 mg |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 2 hours
Secondary outcomes (5)
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.
Measured: 24 and 48 hours
The proportion of patients who used rescue medications within 24 hours.
Measured: 24 hours
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.
Measured: 48 hours.
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.
Measured: 48 hours
The proportion of patients who experienced adverse events
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start27 Jun 2017
- Primary completion7 May 2018
- Study completion7 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine With and Without AuraStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allodynic Therapeutics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Annette C. Toledano, M.D., Principal investigator, Allodynic Therapeutics, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03185143
- Sponsor's protocol ID
- ANODYNE-2
- Status last verified
- May 2018
- First submitted
- 8 Jun 2017
- Last updated
- 14 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03185143
- Acronym / sponsor ID
- ANODYNE-2
- Conditions
- Migraine With and Without Aura
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Allodynic Therapeutics, IncIndustry (pharma, biotech, devices)
- Study start
- 27 Jun 2017 (actual)
- Primary completion
- 7 May 2018 (actual)
- Study completion
- 7 May 2018 (actual)
- First posted
- 14 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This proof-of-concept study compares side-by-side low-dose naltrexone and acetaminophen combination to sumatriptan in the acute treatment of migraine.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Naltrexone and Acetaminophen Combination | Experimental | Drug: Naltrexone and Acetaminophen Combination |
| Sumatriptan 100 mg | Active comparator | Drug: Sumatriptan 100 mg |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Naltrexone and Acetaminophen CombinationTreat a single Qualified Migraine attack. | Drug | Naltrexone and Acetaminophen Combination |
| Sumatriptan 100 mgOne capsule contains Sumatriptan 100 mg and one capsule contains a sham for component B taken together to treat a single Qualified Migraine attack. | Drug | Sumatriptan 100 mg |
| PlaceboOne 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. | Drug | Placebo |
Primary outcome
The proportion of patients having no headache pain at 2 hours.
Time frame: 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).
The proportion of patients having the absence of the most bothersome migraine-associated symptom at 2 hours.
Time frame: 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.
5 secondary outcomes
The proportion of patients having the absence of nausea, photophobia, phonophobia, and neck/shoulder pain at 2 hours.
Time frame: 24 and 48 hours
The proportion of patients who used rescue medications within 24 hours.
Time frame: 24 hours
The proportion of patients who are "sustained pain-free" at 24-hours and 48-hours.
Time frame: 48 hours.
The proportion of patients who had headache pain relapse within 48 hours
Time frame: 48 hours
The proportion of patients who experienced adverse events
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Migraine With and Without Aura
RecruitingPhase 3
Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine
Acute Treatment of Migraine
RecruitingPhase 3
Randomized Study in Children and Adolescents With Migraine: Acute Treatment
Pediatric Migraine
RecruitingPhase 2/3
Efficacy and Safety of BR005-036C Tablets for the Acute Treatment of Migraine in Adults
Migraine, With or Without Aura
RecruitingPhase 2
Study of EVO756 in Adults With Migraine
Migraine
Not yet recruiting
Using Virtual Reality to Teach Mindfulness to People With Migraine
Migraine Disorders, Migraine With Aura
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annette C. Toledano, M.D. principal investigator
Allodynic Therapeutics, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Naltrexone and Acetaminophen Combination and Sumatriptan 100 mg in people with Migraine With and Without Aura, run by Allodynic Therapeutics, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients having no headache pain at 2 hours. (time frame: 2 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2021.