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Pilot Study of Two Different Strengths of DFN-11 Injection for Rapidly Escalating Migraine

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ClinicalTrials.gov Identifier: NCT02571049
Recruitment Status : Completed
First Posted : October 8, 2015
Results First Posted : July 24, 2018
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited

Tracking Information
First Submitted Date  ICMJE October 1, 2015
First Posted Date  ICMJE October 8, 2015
Results First Submitted Date  ICMJE February 15, 2018
Results First Posted Date  ICMJE July 24, 2018
Last Update Posted Date February 26, 2019
Study Start Date  ICMJE September 2015
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 20, 2018)
The Percentage of Subjects Reporting Pain Freedom at 60 Minutes Post-treatment [ Time Frame: 60 minutes post-treatment ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 6, 2015)
The proportion of subjects reporting Pain freedom at 60 minutes post-treatment according to the subject eDiary entries [ Time Frame: 60 minutes post-treatment ]
Change History Complete list of historical versions of study NCT02571049 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: October 6, 2015)
  • To compare the difference between the 2 different treatments of subjects reporting Pain Relief at 120 minutes post-treatment according to the subject eDiary entries [ Time Frame: 120 minutes post-treatment ]
  • To compare the difference between the 2 different treatments of subjects reporting Pain Freedom at 120 minutes post-treatment according to the subject eDiary entries [ Time Frame: 120 minutes post-treatment ]
  • To compare the difference between the 2 different treatments of subjects reporting Headache Severity at 120 minutes post-treatment according to the subject eDiary entries [ Time Frame: 120 minutes post-treatment ]
  • To compare the difference between the 2 different treatments of subjects reporting Subject Relief of Associated Migraine Symptoms (i.e., nausea, photophobia, and phonophobia) at 120 minutes post-treatment according to the subject eDiary entries [ Time Frame: 120 minutes post-treatment ]
  • To compare the difference between the 2 different treatments of Subject Satisfaction of Treatment at 120 minutes post-treatment according to the subject eDiary entries [ Time Frame: 120 minutes post-treatment ]
  • To compare the difference between the 2 different treatments of subjects reporting Migraine Rescue Medication Usage at 24 hours post-treatment according to the subject eDiary entries [ Time Frame: 24 hours post-treatment ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot Study of Two Different Strengths of DFN-11 Injection for Rapidly Escalating Migraine
Official Title  ICMJE Randomized, Double-Blind, Crossover, Comparator Pilot Study of DFN-11 Injection (Strength A vs. Strength B) for Rapidly Escalating Migraine
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
DFN-11 injection and placebo injection administered in one treatment period and two DFN-11 injections administered in another treatment period
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Rapidly Escalating Migraine
Intervention  ICMJE Drug: DFN-11
Sumatriptan 3 mg versus 6 mg
Other Name: Sumatriptan succinate injection
Study Arms  ICMJE
  • Experimental: Sumatriptan 3 mg then 6 mg
    DFN-11 (sumatriptan, 3 mg) and placebo first then two DFN-11 injections
    Intervention: Drug: DFN-11
  • Experimental: Sumatriptan 6 mg then 3 mg
    Two DFN-11 (sumatriptan, 3 mg) injections first then DFN-11 injection and placebo
    Intervention: Drug: DFN-11
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 20, 2018)
24
Original Estimated Enrollment  ICMJE
 (submitted: October 6, 2015)
20
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02571049
Other Study ID Numbers  ICMJE DFN-11-CD-006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dr. Reddy's Laboratories Limited
Study Sponsor  ICMJE Dr. Reddy's Laboratories Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Dr. Reddy's Laboratories Limited
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP