Oral ALLOD-2 vs. Its Components & vs. Placebo in the Acute Treatment of Migraine (ANODYNE-1)

The study consists of a screening visit, at home treatment of a migraine attack with a single
dose of the study drug within 8 weeks, and End-of-Study Visit 2-7 days after treatment of a
moderate or severe migraine attack.

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.