- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03472378
Can DFN-15 Terminate Migraine With Allodynia?
April 12, 2019 updated by: Brian Grosberg, Hartford Hospital
Effects of DFN-15 on Migraine With Allodynia
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
51
Phase
- Phase 2
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
-
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Connecticut
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West Hartford, Connecticut, United States, 06107
- Hartford HealthCare Headache Center
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-
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
Ages Eligible for Study
18 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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 Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo Group
|
Oral Solution of 4.8 mL containing 0 mg of DFN-15
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Experimental: Active Treatment Group
DFN-15
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Oral Solution of 4.8 mL containing 120 mg of DFN-15
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Up to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
May 9, 2018
Primary Completion (Actual)
April 12, 2019
Study Completion (Actual)
April 12, 2019
Study Registration Dates
First Submitted
February 20, 2018
First Submitted That Met QC Criteria
March 20, 2018
First Posted (Actual)
March 21, 2018
Study Record Updates
Last Update Posted (Actual)
April 16, 2019
Last Update Submitted That Met QC Criteria
April 12, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Sensation Disorders
- Headache Disorders, Primary
- Headache Disorders
- Somatosensory Disorders
- Migraine Disorders
- Migraine without Aura
- Migraine with Aura
- Hyperalgesia
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Cyclooxygenase 2 Inhibitors
- Celecoxib
Other Study ID Numbers
- HHC-2017-0224
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
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
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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