Pilot Study of Two Different Strengths of DFN-11 Injection for Rapidly Escalating Migraine
Condition: Rapidly Escalating Migraine
MeSH terms: Migraine Disorders
Intervention: DFN-11
Intervention description: Sumatriptan 3 mg versus 6 mg
Intervention MeSH terms: Sumatriptan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention 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 (Participant, Investigator)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

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

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of episodic migraine, with or without aura for at least 1 year prior to
             screening

          2. 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

          3. 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)

          4. Females of child-bearing potential must have a negative urine pregnancy test at
             screening

          5. Able and willing to read and comprehend written instructions and complete the
             electronic diary information required by the protocol

          6. Must have internet access to complete daily headache diary

        Exclusion Criteria:

          1. Inability to distinguish migraine from other primary headaches

          2. Experiences headache of any kind at a frequency greater than or equal to 15 days per
             month

          3. Chronic opioid therapy (> 10 days in the 30 days prior to screening)

          4. Current treatment with monoamine oxidase A (MAO-A) inhibitors or use within 4 weeks
             before randomization

          5. Hemiplegic or basilar migraine

          6. History, symptoms or signs of ischemic cardiac, cerebrovascular or peripheral vascular
             syndromes

          7. Uncontrolled hypertension (screening systolic/diastolic blood pressure > 140/90 mmHg
             in 2 out of 3 readings)

          8. History of epilepsy or conditions associated, which in the opinion of the
             Investigator, increase the likelihood of present day seizure

          9. History (within 2 years) of drug or alcohol abuse as defined by DSM-IV-TR criteria.

         10. Systemic disease, which in the opinion of the Investigator, would contraindicate
             participation

         11. History of a neurological or psychiatric condition, which in the opinion of the
             Investigator would contraindicate participation

         12. Pregnant or lactating women

         13. Have taken any investigational medication within 30 days before randomization, or are
             scheduled to receive an investigational drug

         14. 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

         15. 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.

         16. Fridericia's corrected QT (QTcF) interval greater than 450 msec

         17. Severe renal impairment (creatinine > 2 mg/dl)

         18. Serum total bilirubin > 2.0 mg/dL

         19. Serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline
             phosphatase > 2.5 times the upper limit of normal

         20. Subjects who in the opinion of the investigator experience rebound headache from
             caffeine usage