Pilot Study of DFN-11 Injection in Medication Overuse Headache

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

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