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Two Dose Levels of DFN-15 vs. Placebo in Patients With Migraine Headaches

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ClinicalTrials.gov Identifier: NCT02472418
Recruitment Status : Completed
First Posted : June 15, 2015
Last Update Posted : April 19, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited

Brief Summary:
Crossover study of DFN-15 dose A versus DFN-15 dose B versus Placebo in the treatment of migraine headaches.

Condition or disease Intervention/treatment Phase
Migraine Drug: DFN-15 Dose A (treatment A) Drug: DFN-15 Dose B (treatment B) Other: Placebo (treatment C) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-Center, Randomized, Placebo-Controlled, Double-Blind, Crossover Study Evaluating Efficacy of DFN-15 in Patients With Migraine Headache With or Without Aura
Actual Study Start Date : June 5, 2015
Actual Primary Completion Date : December 1, 2015
Actual Study Completion Date : May 5, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine
U.S. FDA Resources

Arm Intervention/treatment
Experimental: DFN-15 120 mg (treatment A)
DFN-15 120 mg (treatment A)
Drug: DFN-15 Dose A (treatment A)
DFN-15 Dose A administered
Other Name: DFN-15 120 mg
Experimental: DFN-15 240 mg (treatment B)
DFN-15 240 mg (treatment B)
Drug: DFN-15 Dose B (treatment B)
DFN-15 Dose B administered
Other Name: DFN-15 240 mg
Placebo Comparator: Placebo (treatment C)
Placebo (treatment C)
Other: Placebo (treatment C)
Placebo administered
Other Name: Placebo (no active ingredient)



Primary Outcome Measures :
  1. Pain Free, defined as a score of "0" on a numerical scale of "0" to "3" [ Time Frame: 2 hour ]
    Percentage of subjects who are migraine headache free at 2 hours after taking study drug administration



Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Patients with a history of episodic migraine (as defined by International Classification of Headache Disorders [ICHD]-228) who experience an average of 2 to 6 migraine attacks a month for the past 12 months with no more than 14 headache days per month, and with at least 48 hours of headache-free time between migraine attacks;
  2. Patients with onset of migraine with or without aura before age 50;
  3. Patients who have migraine with or without aura, in which the aura cannot last longer than 60 minutes;
  4. Patients who report usual migraine pain of 2 (moderate) or 3 (severe) on headache pain severity scale.

Exclusion Criteria:

  1. Patients with medication overuse headache (MOH) as defined by ICHD-228:

    • Opioids ≥ 10 days a month during the 90 days prior to screening
    • Combination medications (eg, Fiorinal® ≥ 10 days a month)
    • 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
  2. Patients on chronic warfarin sodium;
  3. Patients taking monoamine oxidase-A (MAO-A) inhibitors;
  4. Patients on unstable dosages of chronic medications during the 3 months prior to and through screening, or who are not willing or able to maintain a stable pre-study dose throughout study participation;
  5. Patients with more than 6 migraine attacks a month and/or more than 14 headache days a month (based upon patient self-report);
  6. Patients with hemiplegic migraine or migraine with brain stem aura or other forms of neurologically complicated migraine;
  7. Patients with atypical aura;
  8. Patients with prolonged aura (more than 1 hour).
  9. Patients with a history of stroke or transient ischemic attack;
  10. Patients with a history of migralepsy or a concurrent diagnosis of seizure disorder;
  11. Patients who cannot differentiate between a migraine headache and a tension-type or cluster headache or any other non-migraine headache;
  12. Patients with a history of more than 10 tension-type headaches per month;
  13. Patients with a history of cluster headache;
  14. Patients with a diagnosis of ICHD-2 "probable migraine";
  15. Patients with uncontrolled hypertension (screening blood pressure ≥ 140/90 mmHg despite appropriate pharmacotherapy);
  16. Patients with severe renal impairment (defined as serum creatinine > 1.9 mg/dL);
  17. Patients with serum total bilirubin > 1.9 mg/dL;
  18. Patients with serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase > 3 times the upper limit of normal;
  19. Patients with positive serology for human immunodeficiency virus (HIV), Hepatitis B surface antigen, Hepatitis C antibody.
  20. Patients with a history of alcohol or substance abuse (including marijuana and medical marijuana) within 1 year that would compromise data collection;
  21. Patients with a history of or current neurological or psychiatric impairment, or cognitive dysfunction that, in the opinion of the investigator, would compromise data collection;
  22. Patients with any other medical condition that, in the judgment of the investigator or medical monitor, would confound the objectives of the study (eg, cancer history [except basal cell carcinoma], systemic lupus erythematosus);
  23. Patients who have participated in a clinical trial involving any medication during the past 30 days or 5 half-lives of the study medication, whichever is longer

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): NCT02472418


Locations
United States, California
Collaborative Neuroscience Network, LLC
Long Beach, California, United States, 90806
California Medical Clinic for Headache
Santa Monica, California, United States, 90404
United States, Massachusetts
MedVadis Research Corporation
Watertown, Massachusetts, United States, 02472
United States, Michigan
Michigan Head Pain & Neurological Institute
Ann Arbor, Michigan, United States, 48104
United States, Missouri
Clinvest/ A Division of Banyan Group, Inc.
Springfield, Missouri, United States, 65807
United States, New Mexico
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, United States, 87102
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited

Publications of Results:
Responsible Party: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT02472418     History of Changes
Other Study ID Numbers: DFN-15-CD-002
First Posted: June 15, 2015    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms