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Efficacy, Tolerability, and Safety of DFN-15

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: NCT03009019
Recruitment Status : Active, not recruiting
First Posted : January 4, 2017
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited

Brief Summary:
Efficacy, Tolerability, and Safety of DFN-15 in episodic migraine with or without aura, being conducted at multiple centers in the United States

Condition or disease Intervention/treatment Phase
Migraine Headache Drug: DFN-15 Active Other: DFN-15 Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 631 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : December 2016
Actual Primary Completion Date : November 2017
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: DFN-15 Active
DFN-15 Active
Drug: DFN-15 Active
Other Name: Celecoxib Oral Solution

Placebo Comparator: DFN-15 Placebo
DFN-15 Placebo
Other: DFN-15 Placebo



Primary Outcome Measures :
  1. Proportion of subjects who are pain-free at 2 hours postdose (first treated double-blind treatment period) [ Time Frame: 2 hours postdose ]
  2. Proportion of subjects who are free from their most bothersome symptom among nausea, photophobia, and phonophobia at 2 hours postdose (first double-blind treatment period) [ Time Frame: 2 hours postdose ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. A history of episodic migraine, who experience 2 to 8 migraine attacks per month for at least the past 12 months, with no more than 14 headache days per month, and with 48 hours of headache-free time between migraine attacks.
  2. Patients who have migraine with or without aura with onset before age 50 years
  3. Report usual migraine pain of 2 (moderate) or 3 (severe) on headache pain severity scale without treatment.
  4. Subjects who are willing and able to:

    1. Evaluate and record pain, migraine symptoms, and study drug effectiveness information in real-time using a subject eDiary for the duration of the study;
    2. Record each instance of the use of study drug and rescue medication in real-time using a subject eDiary for the duration of the study;
    3. Comply with all other study procedures and scheduling requirements.

Exclusion Criteria:

  1. Minors, even if they are in the specified study age range
  2. Medication overuse:

    1. Opioids greater than or equal to 10 days during the 90 days prior to screening
    2. Combination medications (e.g., Fiorinal®) greater than or equal to 10 days during the 90 days prior to screening (applies only if includes opioid and/or barbiturate)
    3. Nonsteroidal Anti-inflammatory Drugs or other simple medications greater than 14 days a month during the 90 days prior to screening
    4. Triptans or ergots greater than or equal to 10 days a month during the 90 days prior to screening
  3. Treated with onabotulinumtoxin A (Botox®) for migraine within 4 months prior to screening. (If treated for cosmetic reasons, subjects may be included).
  4. Current treatment with antipsychotics or use of antipsychotics within 30 days prior to randomization.
  5. Patients who have received treatment with an investigational drug or device within 30 days of randomization, or participated in a central nervous system clinical trial within 2 months prior to randomization
  6. Patients with positive screening test for human immunodeficiency virus [HIV], positive hepatitis B surface antigen (HBsAg), or positive hepatitis C virus [HCV] antibody
  7. Subjects who are employees or immediate relatives of the employees of the Sponsor, any of its affiliates or partners, or of the clinical research study site.

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): NCT03009019


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Sponsors and Collaborators
Dr. Reddy's Laboratories Limited

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Responsible Party: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT03009019     History of Changes
Other Study ID Numbers: DFN-15-CD-006
First Posted: January 4, 2017    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: January 2019

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