Clinical trial NCT02571049: Pilot Study of Two Different Strengths of DFN-11 Injection for Rapidly Escalating Migraine
Official title: Randomized, Double-Blind, Crossover, Comparator Pilot Study of DFN-11 Injection (Strength A vs. Strength B) for Rapidly Escalating Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rapidly Escalating Migraine
Lead sponsor: Dr. Reddy's Laboratories Limited
Sponsor class: INDUSTRY
First posted: 2015-10-08
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: DFN-11 injection and placebo injection administered in one treatment period and two DFN-11 injections administered in another treatment period
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: The Percentage of Subjects Reporting Pain Freedom at 60 Minutes Post-treatment
timeFrame: 60 minutes post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Clinvest
state: Missouri
Study officials:
References:
citation: Cady RK, Munjal S, Cady RJ, Manley HR, Brand-Schieber E. Randomized, double-blind, crossover study comparing DFN-11 injection (3 mg subcutaneous sumatriptan) with 6 mg subcutaneous sumatriptan for the treatment of rapidly-escalating attacks of episodic migraine. J Headache Pain. 2017 Dec;18(1):17. doi: 10.1186/s10194-016-0717-7. Epub 2017 Feb 7.