Low-Dose Naltrexone and Acetaminophen Combination and Its Components in the Acute Treatment of Migraine (ANODYNE-1)

Allodynic Therapeutics

Status and phase: Completed; Phase 2

Conditions: Migraine With or Without Aura

Treatments: Drug: Naltrexone and Acetaminophen; Drug: Matching Placebo; Drug: Acetaminophen Alone; Drug: Naltrexone and Acetaminophen-High Dose; Drug: Naltrexone Alone (regular dose)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03061734

ANODYNE-1

Details and patient eligibility

About

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.

Enrollment: 92 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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92 participants in 5 patient groups, including a placebo group

Naltrexone and Acetaminophen

Experimental group

Description:

Patients take one capsule containing naltrexone and one capsule containing acetaminophen together for a qualifying migraine

Treatment:

Drug: Naltrexone and Acetaminophen

Naltrexon/Acetaminophen-High Capsules

Experimental group

Description:

Patient take one capsule containing naltrexone (high dose) and one capsule containing acetaminophen together for a qualifying migraine

Treatment:

Drug: Naltrexone and Acetaminophen-High Dose

Naltrexone Alone Capsules

Active Comparator group

Description:

Patient take one capsule containing naltrexone and one capsule containing placebo together for a qualifying migraine

Treatment:

Drug: Naltrexone Alone (regular dose)

Acetaminophen Alone Capsules

Active Comparator group

Description:

Patient take one capsule containing naltrexone and one capsule containing placebo together for a qualifying migraine

Treatment:

Drug: Acetaminophen Alone

Placebo Capsules

Placebo Comparator group

Description:

Patient take two capsule containing placebo together for a qualifying migraine

Treatment:

Drug: Matching Placebo