Can DFN-15 Terminate Migraine With Allodynia?
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03472378|
Recruitment Status : Recruiting
First Posted : March 21, 2018
Last Update Posted : March 23, 2018
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
Experimental: Active Treatment Group
Oral Solution of 4.8 mL containing 120 mg of DFN-15
Other Name: Celecoxib
|Placebo Comparator: Placebo Group||
Oral Solution of 4.8 mL containing 0 mg of DFN-15
- 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).
- 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.
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
|Contact: Raymond J Rich-Fiondella, BAfirstname.lastname@example.org|
|Contact: Brian M Grosberg, MD|
|United States, Connecticut|
|Hartford HealthCare Headache Center||Recruiting|
|West Hartford, Connecticut, United States, 06107|
|Contact: Raymond J Rich-Fiondella, BA 860-231-0718 email@example.com|