Clinical trial NCT06245902: An Acute Migraine Factorial Study
Official title: A Clinical Trial to Assess a Single Dose of Low-Dose Naltrexone and Acetaminophen Combination and Its Components in the Acute Treatment of Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Migraine With or Without Aura
Keywords: Migraine Disorders
Lead sponsor: Allodynic Therapeutics, Inc
Sponsor class: INDUSTRY
First posted: 2024-02-07
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

1. Male or female 18 years of age or older.
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 of 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 adequate and reliable contraception throughout the study (e.g., barrier with additional spermicidal, intra-uterine device, hormonal contraception). The male patient must be surgically sterile or commit to the use of 2 different methods of birth control during the study and for 28 days after taking the study drug.

Exclusion Criteria:

1. The patient in the opinion of the investigator, may have medication-overuse headache pain (as defined by ICHD - 3 beta criteria for medication-overuse headache), (analgesic, opioid, ergotamine or triptan overuse) during the 3 months preceding screening.
2. The patient in the opinion of the investigator has chronic migraine (as defined by ICHD - 3 beta criteria for chronic migraine).
3. History of cluster headache or neurologically complicated migraine (hemiplegic, basilar, retinal, ophthalmoplegic migraine).
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, selective serotonin re-uptake inhibitors (SSRIs), serotonin-norepinephrine re-uptake inhibitors (SNRIs), or Botox).
5. Any concurrent medical or psychiatric condition, this includes, but is not limited to chronic unstable debilitating diseases, significant renal or hepatic impairment.
6. A history within the previous 3 years of abuse of any drug, prescription, illicit, or alcohol.
7. 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.
8. Use of opiates or barbiturates more than 3 days per month.
9. Known-hypersensitivity reaction to any of the components of the investigational drug.
10. Consumption of analgesic medication for other conditions on a regular basis, (nonsteroidal anti-inflammatory drugs, or acetaminophen, or muscle relaxants).
11. Use of emergency care treatment more than 3 times in the previous 6 months.
12. Participation in another study with an investigational drug within 30 days prior to randomization and/or a plan to participate during the study.

Primary outcomes:
measure: % of patients reporting no headache pain.
timeFrame: 2 hours post-dose
measure: % of patients having absence of most bothersome migraine-associated symptom (MBS).
timeFrame: 2 hours post-dose
measure: % of patients who have "sustained pain freedom"
timeFrame: 24-hour post-dose.
Secondary outcomes:
measure: % of patients having absence of nausea, photophobia, phonophobia, and neck/shoulder pain
timeFrame: 24-hour post-dose.
measure: % of patients who used rescue medications
timeFrame: 2-24 hours
measure: % of patients who had headache pain relapse.
timeFrame: 2-48 hours
Other outcomes:
measure: % of patients who experienced adverse events
timeFrame: 48 hours
Locations:
city: North Miami
country: United States
facility: Annette C. Toledano MD
state: Florida
Study officials:
affiliation: Allodynic Therapeutics, Inc
name: Annette C Toledano, M.D.
role: STUDY_DIRECTOR
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