Pilot Study of DFN-11 Injection in Medication Overuse Headache
Condition: Medication Overuse Headache
MeSH terms: Headache Disorders, Secondary; Headache
Intervention: DFN-11 Injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Efficacy and Safety Pilot Study of DFN-11 Injection in Medication Overuse Headache
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of medication overuse headache within the past year in the following
             categories

          2. Diagnosis of migraine, with or without aura for at least 12 months

          3. Experience an average of > 10 headache days per month for the past 12 months

          4. Females must:

             i. 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 willing to
             continue throughout the study, or ii. be surgically sterile, (have had a hysterectomy
             or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), or
             iii. be postmenopausal (spontaneous amenorrhea for at least 1 year)

          5. Females of child-bearing potential must have a negative urine pregnancy test at all
             visits.

          6. Able and willing to read and comprehend written instructions and complete the
             electronic diary.

          7. Must have internet access to complete daily headache diary.

        Exclusion Criteria:

          1. Current use of medication for headache/migraine prophylaxis that has not been stable
             for 30 days prior to screening. Stable is defined as no recent dosing change within 30
             days of screening.

          2. Hemiplegic or basilar migraine

          3. History, symptoms or signs of ischemic cardiac, cerebrovascular or peripheral vascular
             syndromes

          4. Uncontrolled hypertension (screening systolic/diastolic blood pressure > 140/90 mmHg
             in 2 out of 3 readings)

          5. Clinically significant hepatic impairment

          6. History of epilepsy or conditions associated, which in the opinion of the
             Investigator, increase the likelihood of present day seizure

          7. History (within 2 years) of drug or alcohol abuse as defined by DSM-IV-TR criteria

          8. Systemic disease, which in the opinion of the Investigator, would contraindicate
             participation

          9. History of a neurological or psychiatric condition, which in the opinion of the
             Investigator would contraindicate participation

         10. Pregnant or lactating women

         11. Have taken any investigational medication within 30 days before screening, or are
             scheduled to receive an investigational drug

         12. 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

         13. 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.

         14. Fridericia's corrected QT (QTcF) interval greater than 450 msec

         15. Severe renal impairment (creatinine > 2 mg/dl)

         16. Serum total bilirubin > 2.0 mg/dL

         17. Serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline
             phosphatase > 2.5 times the upper limit of normal

         18. Subjects with uncontrolled diabetes mellitus, or a glycosylated hemoglobin (HbA1c) >
             7.0%, or with diabetes mellitus requiring insulin

         19. Subjects who in the opinion of the investigator experience rebound headache from
             caffeine usage