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Migraine With or Without AuraPhase 2NCT03194555

The Preventive Treatment of Migraine With Low-Dose Naltrexone and Acetaminophen Combination

A Phase 2 study testing Low-Dose Naltrexone and Acetaminophen Combination in people with Migraine With or Without Aura, run by Allodynic Therapeutics, Inc at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The Preventive Treatment of Migraine with Low-Dose Naltrexone and Acetaminophen Combination: A Small, Randomized, Double-Blind, and Placebo-Controlled Clinical Trial with an Open-Label Extension for None-Responders Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Migraine With or Without Aura
What is being tested?
Low-Dose Naltrexone and Acetaminophen Combination
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
12 participants
Where
1 siteUnited States
Study dates
25 Aug 2017to 28 Jul 2018
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient is a male or a female 18 years of age or older.
  • 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 onset of migraine prior to 50 years of age.
  • Migraine-associated nausea with ≥half of migraine attacks.
  • 5-8 migraine/probable migraine headache days on average per month in the three months prior to Visit 1 and during the Baseline Period.
  • The patient agrees to refrain from taking opiate medications from Visit 1 to 7 days after the last dose of the study drug.
  • 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.
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  • The patient has been taking a stable dose of a medication with migraine prevention potential for at least 3 month prior to the screening visit and agrees to not start, stop, or change dosage of any medication with migraine prevention potential during the study period. (E.g., beta-blockers, calcium channel blockers, tricyclic antidepressants, anticonvulsants, selective serotonin re-uptake inhibitors (SSRIs), serotonin-norepinephrine re-uptake inhibitors (SNRIs), magnesium or riboflavin supplements at high doses, herbal preparations (e.g. feverfew or St. john's wort)), Botulinum toxin must be discontinued one year prior to Visit 1.
  • The patient agrees to forgo any elective surgery for the duration of the study.
  • 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.

Who cannot join

  • Usage of acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs) ≥15 days/month, or ergotamine and triptans >10 days/month, or opioids and barbiturates >2 days/month in the 3 months prior to Visit 1 or during the Baseline Period.
  • Tension-type-like, and/or migraine-like headache on ≥15 days per month in the 3 months prior to Visit 1 or during the Baseline Period. Diagnosis of chronic migraine, cluster headache or neurologically complicated migraine (hemiplegic, basilar, retinal, ophthalmoplegic migraine).
  • Regular use of the following medications for any reason: acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), antipsychotic drugs, monoamine oxidase inhibitors, benzodiazepines, sleep medications, muscle relaxants, anti-emetic medications, blood thinning medications (e.g., warfarin or heparin), cannabinoids, or botulinum toxin to head and neck regions. Low-dose aspirin for cardiovascular disease prophylaxis is permitted.
  • Confounding painful conditions, (e.g. fibromyalgia, chronic low back pain, complex regional pain syndrome, etc.).
  • Diagnosis of any concurrent medical or psychiatric condition; this includes, chronic unstable debilitating diseases such as Parkinson's disease, multiple sclerosis, cancer, significant renal impairment, significant hepatic impairment, etc.
  • The patient has a history or diagnosis of moderate-to-severe hepatic or renal impairment (>2 × the upper limit of normal [ULN] for alanine transaminase or aspartate transaminase. ≥1.5 × ULN for alkaline Phosphatase, bilirubin, BUN, or creatinine). (Patients with elevated bilirubin level due to Gilbert's syndrome are allowed).
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  • The patient has a history within the previous 5 years of abuse of any drug, prescription, illicit, or alcohol.
  • The Female patient is pregnant, actively trying to become 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-allergy to any of the components of the investigational drug.
  • Participation in another study with an investigational drug within 30 days before Visit 1 or during the study.
  • Use of emergency care treatment more than 3 times in the previous 6 months.
  • The patient is in the opinion of the investigator, is unsuitable to participate in this study for any other reason.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Annette Toledano, M.D.

    North Miami, Florida, 33181

Other trials in United States

About this study

Official title: Randomized, Double-Blind, Study to Assess Low-Dose Naltrexone and Acetaminophen Combination in the Prevention of Episodic Migraine in Adults

The Preventive Treatment of Migraine with Low-Dose Naltrexone and Acetaminophen Combination: A Small, Randomized, Double-Blind, and Placebo-Controlled Clinical Trial with an Open-Label Extension for None-Responders

Being tested
Low-Dose Naltrexone and Acetaminophen Combination, Placebo
Keywords
Innate Immune System, Cytokines, Cox-2, Headache, Migraine, Migraine Prevention
Medical subject headings
Headache, Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low-Dose Naltrexone and Acetaminophen CombinationDrug

    Twice daily

  • PlaceboDrug

    Twice daily

Study groups in NCT03194555
Study groupRoleWhat they receive
Low-Dose Naltrexone and Acetaminophen CombinationExperimentalNot described
Receives: Drug: Low-Dose Naltrexone and Acetaminophen Combination
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Monthly Migraine Days (MMD) From Baseline to the Last 28 Days of Treatment Period.

    Migraine with or without aura is defined according to the International Classification of Headache Disorders (ICHD)-3rd edition (beta version). Migraine headaches must be moderate or severe and lasting ≥30 minutes. When the patient falls asleep during migraine and wakes up without it, duration of the attack is reckoned until the time of awakening).

    Measured: From the 28-day baseline period to the last 28 days of the 84-days double-blinded treatment period.

Secondary outcomes (5)

  1. The Number of Participants With More Than 50% Improvement in the Mean Monthly Migraine Days (MMDs)

    MMD stands for change in Monthly Migraine Days from 28-day baseline to the last 28 days of the double-blind treatment period

    Measured: From the 28-day baseline period to the last 28 days of the 84-days double-blinded treatment period.

  2. The Number of Participants With More Than 75% Improvement in the Mean Monthly Migraine Days (MMDs)

    Measured: From the28-day baseline period to the last 28 days of the 84-day treatment period.

  3. The Number of Participants With 100% Improvement in Mean MMD in the Last 28 Days Double-blinded Treatment Period.

    Measured: From the 28-day baseline period to the last 28 days of the 84-day treatment period.

  4. Mean Monthly Acute Migraine Medication Treatment Days Change From Baseline to Last 28 Days of Treatment

    Measured: From the 28-day baseline period to the last 28 days of the 84-day treatment period.

  5. The Change in HIT-6 From Baseline to Last 28 Days of Treatment

    HIT-6 - headache impact test - was designed to provide a global measure of adverse headache impact. Score range is 36-78, Score ≥ 60 - a very severe impact on life, scored ≤ 49 little to no impact on life. The percent responders were calculated as follows: the change from baseline score divided by the score at the baseline minus 36.

    Measured: From the 28-day baseline period to the last 28 days of the 84-day treatment period.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2017
  2. Study start25 Aug 2017
  3. Primary completion26 Jul 2018
  4. Study completion28 Jul 2018

Resources

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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03194555
Sponsor's protocol ID
ANODYNE-3
Status last verified
Mar 2024
First submitted
16 Jun 2017
Last updated
10 Apr 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Low-Dose Naltrexone and Acetaminophen Combination in people with Migraine With or 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 9 inclusion and 12 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 10 Apr 2024. 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 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.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Monthly Migraine Days (MMD) From Baseline to the Last 28 Days of Treatment Period. (time frame: From the 28-day baseline period to the last 28 days of the 84-days double-blinded treatment period.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03194555.

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 10 Apr 2024; AzTrials last refreshed its copy on 8 Nov 2026.

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