Rapidly Escalating Migraine
Conditions
Brief 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.
Detailed description
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
Interventions
DRUGDFN-11
Sumatriptan 3 mg versus 6 mg
Sponsors
Dr. Reddy's Laboratories Limited
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
DFN-11 injection and placebo injection administered in one treatment period and two DFN-11 injections administered in another treatment period
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Percentage of Subjects Reporting Pain Freedom at 60 Minutes Post-treatment | 60 minutes post-treatment |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Subjects All subjects who were randomized into the study | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Randomization | Adverse Event | 0 | 1 |
| Randomization | No migraine attack | 0 | 1 |
| Screening | Did not meet entry criteria | 2 | 2 |
Baseline characteristics
| Characteristic | All Subjects |
|---|---|
| Age, Continuous | 39.80 years STANDARD_DEVIATION 10.4 |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 14 / 20 | 18 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
The Percentage of Subjects Reporting Pain Freedom at 60 Minutes Post-treatment
Time frame: 60 minutes post-treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sumatriptan 3 mg | The Percentage of Subjects Reporting Pain Freedom at 60 Minutes Post-treatment | 50 Percentage of responders |
| Sumatriptan 6 mg | The Percentage of Subjects Reporting Pain Freedom at 60 Minutes Post-treatment | 52.63 Percentage of responders |