Pilot Study of DFN-11 Injection in Medication Overuse Headache

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

Conditions
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Medication Overuse Headache

Intervention / Treatment
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* Drug: DFN-11 Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of medication overuse headache within the past year in the following categories Diagnosis of migraine, with or without aura for at least 12 months Experience an average of > 10 headache days per month for the past 12 months 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) Females of child-bearing potential must have a negative urine pregnancy test at all visits. Able and willing to read and comprehend written instructions and complete the electronic diary. Must have internet access to complete daily headache diary. Exclusion Criteria: 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. 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) Clinically significant hepatic impairment 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 screening, 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 with uncontrolled diabetes mellitus, or a glycosylated hemoglobin (HbA1c) > 7.0%, or with diabetes mellitus requiring insulin 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DFN-11<br>DFN-11 Injection upon occurrence of migraine | Drug: DFN-11 Injection<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Headache Hours in the Baseline Period (28 Days of Subjects Using Their Usual Medication for Headaches) and in the Treatment Period (28 Days of Subjects Using DFN-11 for Headaches) |  | 28 days Baseline period and 28 days of Treatment period (Total 56 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Acute Headache Medication Doses in the Baseline Period (28 Days of Subjects Using Their Usual Medication for Headaches) and in the Treatment Period (28 Days of Subjects Using DFN-11 for Headaches) |  | 28 days Baseline period and 28 days of Treatment period (Total 56 days) |