Pilot Study of Two Different Strengths of DFN-11 Injection for Rapidly Escalating Migraine

Study Overview
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Brief Summary
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Pilot study to compare the efficacy and safety of two strengths of injections of subcutaneous DFN-11 in subjects with rapidly escalating migraine headaches.

Detailed Description
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Pilot study to compare the proportion of subjects experiencing pain freedom at 60 minutes post-treatment between headache treated with Strength A of DFN-11 and Strength B of DFN-11

Official Title
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Randomized, Double-Blind, Crossover, Comparator Pilot Study of DFN-11 Injection (Strength A vs. Strength B) for Rapidly Escalating Migraine

Conditions
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Rapidly Escalating Migraine

Intervention / Treatment
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* Drug: DFN-11


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of episodic migraine, with or without aura for at least 1 year prior to screening Experience an average of 2 to 8 migraines per month for the past 12 months of which approximately 75% or more rapidly escalate to moderate or severe pain within 2 hours of onset Females must: be practicing an effective method of birth control (e.g. prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method [e.g., condoms, diaphragm, or cervical cap with spermicidal foam, cream, or gel], or male partner sterilization) before entry and throughout the study, or be surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), or be postmenopausal (spontaneous amenorrhea for at least 1 year) Females of child-bearing potential must have a negative urine pregnancy test at screening Able and willing to read and comprehend written instructions and complete the electronic diary information required by the protocol Must have internet access to complete daily headache diary Exclusion Criteria: Inability to distinguish migraine from other primary headaches Experiences headache of any kind at a frequency greater than or equal to 15 days per month Chronic opioid therapy (> 10 days in the 30 days prior to screening) Current treatment with monoamine oxidase A (MAO-A) inhibitors or use within 4 weeks before randomization Hemiplegic or basilar migraine History, symptoms or signs of ischemic cardiac, cerebrovascular or peripheral vascular syndromes Uncontrolled hypertension (screening systolic/diastolic blood pressure > 140/90 mmHg in 2 out of 3 readings) History of epilepsy or conditions associated, which in the opinion of the Investigator, increase the likelihood of present day seizure History (within 2 years) of drug or alcohol abuse as defined by DSM-IV-TR criteria. Systemic disease, which in the opinion of the Investigator, would contraindicate participation History of a neurological or psychiatric condition, which in the opinion of the Investigator would contraindicate participation Pregnant or lactating women Have taken any investigational medication within 30 days before randomization, or are scheduled to receive an investigational drug Subjects with a positive urine drug screen for recreational drugs or marijuana (whether legal or not) or for prescription drugs not explained by stated concomitant medications 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 who in the opinion of the investigator experience rebound headache from caffeine usage

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: Crossover Assignment
Interventional Model Description: DFN-11 injection and placebo injection administered in one treatment period and two DFN-11 injections administered in another treatment period
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sumatriptan 3 mg then 6 mg<br>DFN-11 (sumatriptan, 3 mg) and placebo first then two DFN-11 injections | Drug: DFN-11<br>* Sumatriptan 3 mg versus 6 mg<br>* Other names: Sumatriptan succinate injection;|
| Experimental: Sumatriptan 6 mg then 3 mg<br>Two DFN-11 (sumatriptan, 3 mg) injections first then DFN-11 injection and placebo | Drug: DFN-11<br>* Sumatriptan 3 mg versus 6 mg<br>* Other names: Sumatriptan succinate injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Subjects Reporting Pain Freedom at 60 Minutes Post-treatment |  | 60 minutes post-treatment |