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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

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.

Condition or disease Intervention/treatment Phase
Rapidly Escalating Migraine Drug: DFN-11 Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
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
Official Title: Randomized, Double-Blind, Crossover, Comparator Pilot Study of DFN-11 Injection (Strength A vs. Strength B) for Rapidly Escalating Migraine
Study Start Date : September 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine
Drug Information available for: Sumatriptan

Arm Intervention/treatment
Experimental: Sumatriptan 3 mg then 6 mg
DFN-11 (sumatriptan, 3 mg) and placebo first then two DFN-11 injections
Drug: DFN-11
Sumatriptan 3 mg versus 6 mg
Other Name: Sumatriptan succinate injection

Experimental: Sumatriptan 6 mg then 3 mg
Two DFN-11 (sumatriptan, 3 mg) injections first then DFN-11 injection and placebo
Drug: DFN-11
Sumatriptan 3 mg versus 6 mg
Other Name: Sumatriptan succinate injection




Primary Outcome Measures :
  1. The Percentage of Subjects Reporting Pain Freedom at 60 Minutes Post-treatment [ Time Frame: 60 minutes post-treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02571049


Locations
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United States, Missouri
Clinvest
Springfield, Missouri, United States, 65807
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited

Publications of Results:
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Responsible Party: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT02571049     History of Changes
Other Study ID Numbers: DFN-11-CD-006
First Posted: October 8, 2015    Key Record Dates
Results First Posted: July 24, 2018
Last Update Posted: February 26, 2019
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Sumatriptan
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vasoconstrictor Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs