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

July 23, 2018 updated by: Dr. Reddy's Laboratories Limited
Safety and Efficacy of DFN-11 in patients with episodic migraines with or without aura.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
268

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
2 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dr. Reddy's Laboratories Limited

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 21, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 26, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 1, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 7, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 26, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DFN-11-CD-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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