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DFN-11 Injection in Episodic Migraine With or Without Aura (RESTOR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02569853
Recruitment Status : Completed
First Posted : October 7, 2015
Results First Posted : July 26, 2018
Last Update Posted : July 26, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited

Study Description
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Brief Summary:
Safety and Efficacy of DFN-11 in patients with episodic migraines with or without aura.

Condition or disease Intervention/treatment Phase
Episodic Migraine Drug: DFN-11 Other: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 268 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Actual Study Start Date : September 21, 2015
Actual Primary Completion Date : May 30, 2017
Actual Study Completion Date : February 26, 2018

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

Arms and Interventions
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Arm Intervention/treatment
Experimental: DFN-11
DFN-11 active injection upon occurrence of migraine
 Drug: DFN-11
Placebo Comparator: Placebo
Placebo injection upon occurrence of migraine
 Other: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. The Percentage of Subjects in the Double-blind Period Who Are Pain Free at 2 Hours After Dosing as Reported by the Subject in the eDiary [ Time Frame: 2 hours ]

Secondary Outcome Measures :
  1. The Percentage of Subjects in the Double-blind Period Who Are Pain Free at 1 Hour After Dosing as Reported by the Subject in the eDiary [ Time Frame: 1 hour ]

Eligibility Criteria
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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. If female, a subject must have a negative serum pregnancy test at screening, does not plan to become pregnant during the study, and is not lactating
  2. If female, a subject also must have a negative urine pregnancy test at all subsequent study visits after the Screening Visit, and agree to practice a reliable form of contraception or abstinence during the study. Acceptable forms of contraception include implants, injectables, combined oral contraceptives, an intrauterine device, a vasectomized partner, an exclusively female partner, and double-barrier methods.
  3. If male (with female partner), a subject must agree to practice a reliable form of contraception or abstinence during the study.
  4. A history of episodic migraine who experience 2 to 6 migraine attacks a month for at least the past 12 months with no more than 14 migraine headache days per month, and with 48 hours of headache free time between migraine headaches
  5. Have migraine with or without aura; if with aura, the aura cannot last longer than 60 minutes

Exclusion Criteria:

  1. Minors, even if they are in specified study age range

  2. Medication overuse headache as defined by ICHD II:

    • Opioids ≥ 10 days a month during the 90 days prior to screening
    • Combination medications (e.g., Fiorinal®) ≥ 10 days a month during the 90 days prior to screening
    • Nonsteroidal anti-inflammatory drugs (NSAIDs) or other simple medications > 14 days a month during the 90 days prior to screening
    • Triptans or ergots ≥ 10 days a month during the 90 days prior to screening
  3. Subjects treated with onabotulinumtoxin A (Botox®) or other botulinum toxin treatment; or history of receiving such treatment during the 180 days prior to screening
  4. On unstable dosages of migraine prophylactic medications during the 30 days prior to and through screening
  5. Taking mini-prophylaxis for menstrual migraine
  6. Subjects with hemiplegic or basilar migraine or other forms of neurologically complicated migraine
  7. Subjects who have prolonged aura (i.e., more than 1 hour)
  8. Cerebrovascular disease including but not limited to a history of stroke or transient ischemic attack (TIA)
  9. A history of migralepsy (seizure following a migraine) or a concurrent diagnosis of seizure disorder
  10. Subjects who cannot differentiate between a migraine headache and tension-type or cluster headache or other types of headache
  11. Subjects with a history of more than occasional (based on Investigator's judgment) tension-type headache (distinct from migraine headache days count).
  12. Subjects with a history of cluster headaches
  13. Subjects with the diagnosis of "probable migraine" (ICHD II)
  14. Ischemic coronary artery disease (CAD): including but not limited to angina pectoris, history of myocardial infarction or documented silent ischemia or coronary artery vasospasm, including Prinzmetal's angina
  15. Subjects with Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders
  16. Subjects with a history of congenital heart disease
  17. A history of uncontrolled hypertension or screening systolic/diastolic > 140/90 mmHg
  18. Have peripheral vascular disease including but not limited to ischemic bowel disease (IBD) and Raynaud's disease.
  19. Any abnormal physiology and/or pathology which, in the opinion of the Investigator or Sponsor, which would be contraindicated for study participation and would not allow the objectives of the study to be met
  20. Subjects who show any 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.
  21. Fridericia's corrected QT (QTcF) interval greater than 450 msec
  22. Severe renal impairment (creatinine > 2 mg/dl)
  23. Serum total bilirubin > 2.0 mg/dL
  24. Serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase > 2.5 times the upper limit of normal
  25. Subjects with uncontrolled diabetes mellitus, or a glycosylated hemoglobin (HbA1c) > 7.0%, or with diabetes mellitus requiring insulin
  26. A history of alcohol or substance use disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Edition V (DSM-V) (including marijuana) within 1 year prior to screening
  27. Current treatment with antipsychotics or use of antipsychotics within 30 days of screening
  28. A history of or current neurological or psychiatric impairment, including but not limited to psychosis, current major depression, bipolar disorder or cognitive dysfunction that, in the opinion of the Investigator, would compromise data collection
  29. Subjects who have received treatment with an investigational drug or device within 30 days of the screening visit or participated in a central nervous system clinical trial in the 3 months prior to screening
  30. Subjects with any other medical condition that, in the judgment of the Investigator and/or Medical Monitor, would confound the objectives of the study (e.g., positive screening test for human immunodeficiency virus [HIV], hepatitis B surface antigen positive or hepatitis C positive, a known history of systemic lupus erythematosis)
  31. Subjects who plan to donate blood, sperm, or oocytes during the study and for 30 days after the last dose of study medication
  32. Subjects who are employees or immediate relatives of the employees of the Sponsor, any of its affiliates or partners, or of the study center
Contacts and Locations
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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): NCT02569853


Locations
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United States, California
Dr. Reddy's Investigational Site #18
Santa Monica, California, United States, 80404
United States, Florida
Dr. Reddy's Investigational Site #24
Jacksonville, Florida, United States, 32256
Dr. Reddy's Investigational Site #23
Maitland, Florida, United States, 32751
United States, Idaho
Dr. Reddy's Investigational Site #27
Boise, Idaho, United States, 83716
United States, Massachusetts
Dr. Reddy's Investigational Site #20
Watertown, Massachusetts, United States, 02472
United States, Michigan
Dr. Reddy's Investigational Site #19
Ann Arbor, Michigan, United States, 48104
United States, Missouri
Dr. Reddy's Investigational Site #13
Springfield, Missouri, United States, 65807
United States, New Mexico
Dr. Reddy's Investigational Site #12
Albuquerque, New Mexico, United States, 87102
United States, New York
Dr. Reddy's Investigational Site #10
Williamsville, New York, United States, 14221
United States, North Carolina
Dr. Reddy's Investigational Site #26
Greensboro, North Carolina, United States, 27405
United States, Ohio
Dr. Reddy's Investigational Site #15
Cleveland, Ohio, United States, 44122
United States, South Carolina
Dr. Reddy's Investigational Site #21
Mount Pleasant, South Carolina, United States, 29464
United States, Tennessee
Dr. Reddy's Investigational Site #25
Memphis, Tennessee, United States, 38119
United States, Texas
Dr. Reddy's Investigational Site #14
Dallas, Texas, United States, 75231
Dr. Reddy's Investigational Site #16
Hurst, Texas, United States, 76054
United States, Utah
Dr. Reddy's Investigational Site #17
West Jordan, Utah, United States, 84088
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
  Study Documents (Full-Text)

Documents provided by Dr. Reddy's Laboratories Limited:
Study Protocol and Statistical Analysis Plan  [PDF] August 24, 2016

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT02569853    
Other Study ID Numbers: DFN-11-CD-004
First Posted: October 7, 2015    Key Record Dates
Results First Posted: July 26, 2018
Last Update Posted: July 26, 2018
Last Verified: June 2018
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases