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Can DFN-15 Terminate Migraine With Allodynia?

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ClinicalTrials.gov Identifier: NCT03472378
Recruitment Status : Recruiting
First Posted : March 21, 2018
Last Update Posted : March 23, 2018
Sponsor:
Collaborators:
Rami Burstein, PhD, Beth Israel Deaconess Medical Center
Dr. Reddy's Laboratories Limited
Information provided by (Responsible Party):
Brian Grosberg, Hartford Hospital

Brief Summary:
The majority of migraineurs seeking secondary or tertiary medical care develop cutaneous allodynia during the course of migraine, a sensory abnormality mediated by sensitization of central trigeminovascular neurons in the spinal trigeminal nucleus. Triptan therapy can render allodynic migraineurs pain-free within a narrow window of time (20-120 min) that opens with the onset of pain and closes with the establishment of central sensitization. This calls for the development of drugs that can tackle ongoing central sensitization and render allodynic migraineurs pain-free after the window for triptan therapy has expired. There are two main objectives the investigators seek to achieve from this study: to determine whether oral administration of DFN-15 (solution of a COX2 inhibitor, Celecoxib) terminates migraine attacks when given to allodynic participants 3 hours after attack onset; and to determine whether mechanical and heat allodynia that develop during acute migraine attacks could be reversed by late (> 3hrs after attack onset) treatment with DFN-15. Participants will be recruited from the Headache Center and randomized in a double-blinded fashion to receive either the active drug (DFN-15) or placebo in a ratio of 4:1.The participants will be instructed to return to the clinic during a migraine. At the 'during-migraine' visit, which will begin 3 hours after onset of headache, the investigators will document headache intensity, associated symptoms, and mechanical and heat pain threshold (first) before treatment (at 180 min after onset of headache) and (second) at a 120 min after treatment (5 hours after headache onset). Based on our prior experience studying migraine patients, the investigators plan to screen 100 patients to achieve 50 participants completing the 2 study visits as planned. The active drug group will consist of 80/100 patients and 20/100 patients will receive the placebo. The study will be terminated as soon as the first 40 participants who received the DFN-15 and first 10 patients who received placebo completed visit 2.

Condition or disease Intervention/treatment Phase
Migraine With Aura Migraine Without Aura Allodynia Drug: DFN-15 Other: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of DFN-15 on Migraine With Allodynia
Estimated Study Start Date : April 1, 2018
Estimated Primary Completion Date : August 1, 2018
Estimated Study Completion Date : September 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

Arm Intervention/treatment
Experimental: Active Treatment Group
DFN-15
Drug: DFN-15
Oral Solution of 4.8 mL containing 120 mg of DFN-15
Other Name: Celecoxib

Placebo Comparator: Placebo Group Other: Placebo
Oral Solution of 4.8 mL containing 0 mg of DFN-15




Primary Outcome Measures :
  1. Headache Pain Intensity [ Time Frame: Up to 6 months ]
    The proportion of patients demonstrating a decrease in their headache pain intensity is greater than 50% (post-treatment compared to pre-treatment). Pain intensity will be measured with a visual analog scale from 0 (no pain) to 10 (worst pain imaginable).


Secondary Outcome Measures :
  1. Allodynia [ Time Frame: Up to 6 months ]
    The proportion of patients demonstrating allodynia before and after treatment; allodynia to thermal stimuli is defined as pain threshold < 41 degrees Celsius, and to mechanical stimuli as pressure pain threshold of < 30 g.



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • History of migraine with or without aura for at least 3 years, based on the International Classification of Headache disorders
  • Two or more migraine attacks per month on average during the year prior to enrollment
  • Ability to give written consent to enrollment

Exclusion Criteria:

  • Fifteen or more headache days per month, on average
  • Aspirin or NSAID induced asthma or allergy
  • Sulfa allergy
  • Any woman who is pregnant or lactacting
  • History of any of the following: Coronary artery bypass surgery, heart attack, angina, stroke, serious gastrointestinal bleeding, peptic ulcer disease, and/or chronic kidney disease
  • Medical Conditions requiring the use of diuretics or daily anticoagulants
  • Severe uncontrolled medical problems or medications that may influence measurements

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): NCT03472378


Contacts
Contact: Raymond J Rich-Fiondella, BA 860-231-0718 headacheresearch@hhchealth.org
Contact: Brian M Grosberg, MD

Locations
United States, Connecticut
Hartford HealthCare Headache Center Recruiting
West Hartford, Connecticut, United States, 06107
Contact: Raymond J Rich-Fiondella, BA    860-231-0718    headacheresearch@hhchealth.org   
Sponsors and Collaborators
Hartford Hospital
Rami Burstein, PhD, Beth Israel Deaconess Medical Center
Dr. Reddy's Laboratories Limited
  Study Documents (Full-Text)

Documents provided by Brian Grosberg, Hartford Hospital:

Responsible Party: Brian Grosberg, Brian M Grosberg, MD, Hartford Hospital
ClinicalTrials.gov Identifier: NCT03472378     History of Changes
Other Study ID Numbers: HHC-2017-0224
First Posted: March 21, 2018    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Migraine Disorders
Migraine with Aura
Migraine without Aura
Hyperalgesia
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Signs and Symptoms