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Can DFN-15 Terminate Migraine With Allodynia?

Primary Purpose

Migraine With Aura, Migraine Without Aura, Allodynia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
DFN-15
Placebo
Sponsored by
Hartford Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine With Aura

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hartford HealthCare Headache Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active Treatment Group

Placebo Group

Arm Description

DFN-15

Outcomes

Primary Outcome Measures

Headache Pain Intensity
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

Allodynia
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.

Full Information

First Posted
February 20, 2018
Last Updated
April 12, 2019
Sponsor
Hartford Hospital
Collaborators
Rami Burstein, PhD, Beth Israel Deaconess Medical Center, Dr. Reddy's Laboratories Limited
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1. Study Identification

Unique Protocol Identification Number
NCT03472378
Brief Title
Can DFN-15 Terminate Migraine With Allodynia?
Official Title
Effects of DFN-15 on Migraine With Allodynia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
May 9, 2018 (Actual)
Primary Completion Date
April 12, 2019 (Actual)
Study Completion Date
April 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hartford Hospital
Collaborators
Rami Burstein, PhD, Beth Israel Deaconess Medical Center, Dr. Reddy's Laboratories Limited

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine With Aura, Migraine Without Aura, Allodynia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Treatment Group
Arm Type
Experimental
Arm Description
DFN-15
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
DFN-15
Other Intervention Name(s)
Celecoxib
Intervention Description
Oral Solution of 4.8 mL containing 120 mg of DFN-15
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Oral Solution of 4.8 mL containing 0 mg of DFN-15
Primary Outcome Measure Information:
Title
Headache Pain Intensity
Description
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).
Time Frame
Up to 6 months
Secondary Outcome Measure Information:
Title
Allodynia
Description
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.
Time Frame
Up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Hartford HealthCare Headache Center
City
West Hartford
State/Province
Connecticut
ZIP/Postal Code
06107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Can DFN-15 Terminate Migraine With Allodynia?

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