DFN-11 Injection in Episodic Migraine With or Without Aura

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

Conditions
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Episodic Migraine

Intervention / Treatment
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* Drug: DFN-11
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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. If male (with female partner), a subject must agree to practice a reliable form of contraception or abstinence during the study. 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 Have migraine with or without aura; if with aura, the aura cannot last longer than 60 minutes Exclusion Criteria: Minors, even if they are in specified study age range 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 Subjects treated with onabotulinumtoxin A (Botox®) or other botulinum toxin treatment; or history of receiving such treatment during the 180 days prior to screening On unstable dosages of migraine prophylactic medications during the 30 days prior to and through screening Taking mini-prophylaxis for menstrual migraine Subjects with hemiplegic or basilar migraine or other forms of neurologically complicated migraine Subjects who have prolonged aura (i.e., more than 1 hour) Cerebrovascular disease including but not limited to a history of stroke or transient ischemic attack (TIA) A history of migralepsy (seizure following a migraine) or a concurrent diagnosis of seizure disorder Subjects who cannot differentiate between a migraine headache and tension-type or cluster headache or other types of headache Subjects with a history of more than occasional (based on Investigator's judgment) tension-type headache (distinct from migraine headache days count). Subjects with a history of cluster headaches Subjects with the diagnosis of probable migraine (ICHD II) 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 Subjects with Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders Subjects with a history of congenital heart disease A history of uncontrolled hypertension or screening systolic/diastolic > 140/90 mmHg Have peripheral vascular disease including but not limited to ischemic bowel disease (IBD) and Raynaud's disease. 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 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. Fridericia's corrected QT (QTcF) interval greater than 450 msec Severe renal impairment (creatinine > 2 mg/dl) Serum total bilirubin > 2.0 mg/dL Serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase > 2.5 times the upper limit of normal Subjects with uncontrolled diabetes mellitus, or a glycosylated hemoglobin (HbA1c) > 7.0%, or with diabetes mellitus requiring insulin 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 Current treatment with antipsychotics or use of antipsychotics within 30 days of screening 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 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 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) Subjects who plan to donate blood, sperm, or oocytes during the study and for 30 days after the last dose of study medication Subjects who are employees or immediate relatives of the employees of the Sponsor, any of its affiliates or partners, or of the study center

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DFN-11<br>DFN-11 active injection upon occurrence of migraine | Drug: DFN-11<br> <br> |
| Placebo Comparator: Placebo<br>Placebo injection upon occurrence of migraine | Other: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Subjects in the Double-blind Period Who Are Pain Free at 2 Hours After Dosing as Reported by the Subject in the eDiary |  | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Subjects in the Double-blind Period Who Are Pain Free at 1 Hour After Dosing as Reported by the Subject in the eDiary |  | 1 hour |