Migraine With AuraPhase 2NCT03472378
Can DFN-15 Terminate Migraine With Allodynia?
A Phase 2 study testing DFN-15 in people with Migraine With Aura and Migraine Without Aura, run by Hartford Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine With Aura, Migraine Without Aura, Allodynia
- What is being tested?
- DFN-15
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2018to 12 Apr 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Hartford HealthCare Headache Center
West Hartford, Connecticut, 06107
About this study
Official title: 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.
- Conditions
- Migraine With Aura, Migraine Without Aura, Allodynia
- Being tested
- DFN-15, Placebo
- Medical subject headings
- Migraine with Aura, Migraine without Aura, Hyperalgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DFN-15Drug
Also called Celecoxib
Oral Solution of 4.8 mL containing 120 mg of DFN-15
PlaceboOther
Oral Solution of 4.8 mL containing 0 mg of DFN-15
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment Group | Experimental | DFN-15 Receives: Drug: DFN-15 |
| Placebo Group | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 6 months
Secondary outcomes (1)
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.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2018
- Study start9 May 2018
- Primary completion12 Apr 2019
- Study completion12 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine With AuraStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hartford Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Rami Burstein, PhD, Beth Israel Deaconess Medical Center, Dr. Reddy's Laboratories Limited
- Responsible party
- Principal investigator, Brian Grosberg, Hartford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03472378
- Sponsor's protocol ID
- HHC-2017-0224
- Status last verified
- Apr 2019
- First submitted
- 20 Feb 2018
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of DFN-15 on Migraine With Allodynia
- ClinicalTrials.gov ID
- NCT03472378
- Acronym / sponsor ID
- HHC-2017-0224
- Conditions
- Migraine With Aura, Migraine Without Aura, Allodynia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Hartford HospitalUniversity, hospital or other
- Collaborators
- Rami Burstein, PhD, Beth Israel Deaconess Medical Center, Dr. Reddy's Laboratories Limited
- Study start
- 9 May 2018 (actual)
- Primary completion
- 12 Apr 2019 (actual)
- Study completion
- 12 Apr 2019 (actual)
- First posted
- 21 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Treatment Group | Experimental | Drug: DFN-15DFN-15 |
| Placebo Group | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DFN-15Also: CelecoxibOral Solution of 4.8 mL containing 120 mg of DFN-15 | Drug | Active Treatment Group |
| PlaceboOral Solution of 4.8 mL containing 0 mg of DFN-15 | Other | Placebo Group |
Primary outcome
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).
1 secondary outcome
Allodynia
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DFN-15 in people with Migraine With Aura and Migraine Without Aura, run by Hartford Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache Pain Intensity (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.