DFN-11 Injection in Episodic Migraine With or Without Aura
Condition: Episodic Migraine
MeSH terms: Migraine Disorders
Intervention: DFN-11; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 268.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Safety and Efficacy of DFN-11 in patients with episodic migraines with or without aura.
    

Eligibility criteria:

        Inclusion Criteria:

          1. If female, a subject must have a negative serum pregnancy test at screening, does not
             plan to become pregnant during the study, and is not lactating

          2. If female, a subject also must have a negative urine pregnancy test at all subsequent
             study visits after the Screening Visit, and agree to practice a reliable form of
             contraception or abstinence during the study. Acceptable forms of contraception
             include implants, injectables, combined oral contraceptives, an intrauterine device, a
             vasectomized partner, an exclusively female partner, and double-barrier methods.

          3. If male (with female partner), a subject must agree to practice a reliable form of
             contraception or abstinence during the study.

          4. A history of episodic migraine who experience 2 to 6 migraine attacks a month for at
             least the past 12 months with no more than 14 migraine headache days per month, and
             with 48 hours of headache free time between migraine headaches

          5. Have migraine with or without aura; if with aura, the aura cannot last longer than 60
             minutes

        Exclusion Criteria:

          1. Minors, even if they are in specified study age range

          2. Medication overuse headache as defined by ICHD II:

               -  Opioids ≥ 10 days a month during the 90 days prior to screening

               -  Combination medications (e.g., Fiorinal®) ≥ 10 days a month during the 90 days
                  prior to screening

               -  Nonsteroidal anti-inflammatory drugs (NSAIDs) or other simple medications > 14
                  days a month during the 90 days prior to screening

               -  Triptans or ergots ≥ 10 days a month during the 90 days prior to screening

          3. Subjects treated with onabotulinumtoxin A (Botox®) or other botulinum toxin treatment;
             or history of receiving such treatment during the 180 days prior to screening

          4. On unstable dosages of migraine prophylactic medications during the 30 days prior to
             and through screening

          5. Taking mini-prophylaxis for menstrual migraine

          6. Subjects with hemiplegic or basilar migraine or other forms of neurologically
             complicated migraine

          7. Subjects who have prolonged aura (i.e., more than 1 hour)

          8. Cerebrovascular disease including but not limited to a history of stroke or transient
             ischemic attack (TIA)

          9. A history of migralepsy (seizure following a migraine) or a concurrent diagnosis of
             seizure disorder

         10. Subjects who cannot differentiate between a migraine headache and tension-type or
             cluster headache or other types of headache

         11. Subjects with a history of more than occasional (based on Investigator's judgment)
             tension-type headache (distinct from migraine headache days count).

         12. Subjects with a history of cluster headaches

         13. Subjects with the diagnosis of "probable migraine" (ICHD II)

         14. Ischemic coronary artery disease (CAD): including but not limited to angina pectoris,
             history of myocardial infarction or documented silent ischemia or coronary artery
             vasospasm, including Prinzmetal's angina

         15. Subjects with Wolff-Parkinson-White syndrome or arrhythmias associated with other
             cardiac accessory conduction pathway disorders

         16. Subjects with a history of congenital heart disease

         17. A history of uncontrolled hypertension or screening systolic/diastolic > 140/90 mmHg

         18. Have peripheral vascular disease including but not limited to ischemic bowel disease
             (IBD) and Raynaud's disease.

         19. Any abnormal physiology and/or pathology which, in the opinion of the Investigator or
             Sponsor, which would be contraindicated for study participation and would not allow
             the objectives of the study to be met

         20. Subjects who show any clinical laboratory or electrocardiogram (ECG) abnormality that
             in the opinion of the Investigator would endanger the subject or interfere with the
             study conduct. If the results of the clinical laboratory or ECG are outside of normal
             reference range the subject may still be enrolled but only if these findings are
             determined to be not clinically significant by the Investigator. This determination
             must be recorded in the subject's source document prior to enrolment.

         21. Fridericia's corrected QT (QTcF) interval greater than 450 msec

         22. Severe renal impairment (creatinine > 2 mg/dl)

         23. Serum total bilirubin > 2.0 mg/dL

         24. Serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline
             phosphatase > 2.5 times the upper limit of normal

         25. Subjects with uncontrolled diabetes mellitus, or a glycosylated hemoglobin (HbA1c) >
             7.0%, or with diabetes mellitus requiring insulin

         26. A history of alcohol or substance use disorder according to the Diagnostic and
             Statistical Manual of Mental Disorders, Edition V (DSM-V) (including marijuana) within
             1 year prior to screening

         27. Current treatment with antipsychotics or use of antipsychotics within 30 days of
             screening

         28. A history of or current neurological or psychiatric impairment, including but not
             limited to psychosis, current major depression, bipolar disorder or cognitive
             dysfunction that, in the opinion of the Investigator, would compromise data collection

         29. Subjects who have received treatment with an investigational drug or device within 30
             days of the screening visit or participated in a central nervous system clinical trial
             in the 3 months prior to screening

         30. Subjects with any other medical condition that, in the judgment of the Investigator
             and/or Medical Monitor, would confound the objectives of the study (e.g., positive
             screening test for human immunodeficiency virus [HIV], hepatitis B surface antigen
             positive or hepatitis C positive, a known history of systemic lupus erythematosis)

         31. Subjects who plan to donate blood, sperm, or oocytes during the study and for 30 days
             after the last dose of study medication

         32. Subjects who are employees or immediate relatives of the employees of the Sponsor, any
             of its affiliates or partners, or of the study center