A Phase 4 interventional study of Migranal nasal spray at 1 hour and Migranal nasal spray at 4 hour in Migraine, sponsored by Thomas Jefferson University. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-03-11.
Sponsored by Thomas Jefferson University · Phase 4, Interventional, and Treatment
This is a research study looking at Migranal (study drug) in the treatment of two migraine attacks in patients who have a history of cutaneous allodynia (pronounced q-tay-nee-us al-o-din-ee-a). Cutaneous allodynia is an increased skin sensitivity experienced during a headache. It has been noted in several studies that in patients with migraine, seventy nine percent of the patients experienced allodynia on the facial skin on the same side as the headache. Understanding more about allodynia may help us understand how the pain system works in migraine.
This study will compare the differences, if any, in attacks treated early with study drug (at 1-hour from onset) and attacks treated later (at 4-hours). You will be asked to treat one attack early and one attack late for this study. If the first attack you treat is early (at 1 hour following onset of throbbing pain) then the second attack you treat should be late (at 4 hours following onset of throbbing pain).
It is hoped that this study will provide information on the use of Migranal in subjects who have cutaneous allodynia. The results from this study may be used in the development of larger clinical trials. The study drug is a medication that is taken in the form of nasal spray.
This is a three visit trial consisting of a screening visit, one follow-up visit and a termination visit. Subjects will be screened using the Cutaneous Allodynia Screening Tool (Appendix A) and the investigator will determine whether or not the subject experiences episodic migraine headaches associated with cutaneous allodynia. Those subjects who test positive for the afore-stated will then proceed with the treatment phase of the project.
Migranal® will be taken by the subject at home at 1-hour following the onset of throbbing pain for one of the two qualifying migraine attacks and at 4-hours following onset of throbbing pain for the second qualifying migraine attack. Migranal® 4 mg. will be self administered by each subject in the following manner: one spray in each nostril, wait 15 minutes then follow with one spray in each nostril. This will deliver the desired 4 mg. dose. Cutaneous allodynia assessments will be made periodically prior to and after administration of study drug. Subjects will be asked to return to the center within 1 week of treating each attack. Subjects will be instructed to treat their 1st qualifying attack within 6 weeks of the screening visit and their 2nd qualifying attack within 6 weeks of their follow-up visit 1.
Migraine pain and associated symptoms assessments will be measured by the subjects for 24-hours from the administration of study drug for each attack.
1,558 studies on the registry are indexed under Migraine Disorders; 301 are open to participants now.
This study's enrollment of 64 is below the median of 80 across 1,197 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Thomas Jefferson University is the lead sponsor of 390 studies on the registry; 72 are open to participants now.
Of its 45 completed or terminated interventional studies of FDA-regulated products, 21 (47%) have results posted.
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Exclusion Criteria:
All subjects were asked to treat one headache at 1 hour (early) and one headache at 4 hours after onset of throbbing (late). Dose of nasal spray constant for both time points. The subject could determine the order in which they could treat the headaches (early (first treatment phase) then late (second treatment phase), or late (first treatment phase) then early (second treatment phase).
Drug: Migranal nasal spray at 1 hour
All subjects were asked to treat one headache at 1 hour (early) and one headache at 4 hours after onset of throbbing (late). Dose of nasal spray constant for both time points. The subject could determine the order in which they could treat the headaches (early (first treatment phase) then late (second treatment phase), or late (first treatment phase) then early (second treatment phase).
Drug: Migranal nasal spray at 4 hour
Migranal® 4 mg. will be self administered by each subject in the following manner: one spray in each nostril, wait 15 minutes then follow with one spray in each nostril. This will deliver the desired 4 mg. dose.
Also known as: Dihydroergotamine (DHE)
Migranal® 4 mg. will be self administered by each subject in the following manner: one spray in each nostril, wait 15 minutes then follow with one spray in each nostril. This will deliver the desired 4 mg. dose.
Also known as: Dihydroergotamine (DHE)
Number of Subjects Who Were Pain Free at 2 Hours Post Treatment With Study Drug.
Number of subjects who were pain free at 2 hours after treatment with study medication when they treated a migraine early (defined as treatment within 1 hour of onset of throbbing pain) compared to the number of subjects who were pain free at 2 hours after treatment with study medication when they treated late (defined as 4 hours after onset of throbbing pain). "Pain free" is defined as a subject rating of zero on a 4 point pain scale; (0=None, 1=mild, 2= moderate, 3=severe).
Time frame: 2 hours post treatment with study medication
Number of Subjects Who Had Pain Relief at 2 Hours Post Treatment With Study Drug.
Number of subjects who had pain relief at 2 hours after treatment with study medication when they treated a migraine early (defined as treatment within 1 hour of onset of throbbing pain) compared to the number of subjects who were pain relief at 2 hours after treatment with study medication when they treated late (defined as 4 hours after onset of throbbing pain). "Pain reduction" is defined as a subject with a 1 or more point decrease on a 4 point pain scale; (0=None, 1=mild, 2= moderate, 3=severe).
Time frame: 2 hours post treatment with study medication
Participants were recruited from our office practice or surrounding community and screened at the Jefferson Headache Center between 8/21/06 and 6/18/08.
| Milestone | Migranal: All Subjects |
|---|---|
| Started | 64 |
| Completed | 35 |
| Not completed | 29 |
| Withdrew: Lost to follow-up | 5 |
| Withdrew: Withdrawal by subject | 6 |
| Withdrew: Treated only 1 or no headaches | 18 |
| Milestone | Migranal: All Subjects |
|---|---|
| Started | 35 |
| Completed | 22 |
| Not completed | 13 |
| Withdrew: Treated 2 early or 2 late headaches | 1 |
| Withdrew: Treated out of protocol for early and late | 12 |
Number of subjects who were pain free at 2 hours after treatment with study medication when they treated a migraine early (defined as treatment within 1 hour of onset of throbbing pain) compared to the number of subjects who were pain free at 2 hours after treatment with study medication when they treated late (defined as 4 hours after onset of throbbing pain). "Pain free" is defined as a subject rating of zero on a 4 point pain scale; (0=None, 1=mild, 2= moderate, 3=severe).
| participants | Migranal: Early Treatment | Migranal Late Treatment |
|---|---|---|
| Number of Subjects Who Were Pain Free at 2 Hours Post Treatment With Study Drug. | 4 | 8 |
Number of subjects who had pain relief at 2 hours after treatment with study medication when they treated a migraine early (defined as treatment within 1 hour of onset of throbbing pain) compared to the number of subjects who were pain relief at 2 hours after treatment with study medication when they treated late (defined as 4 hours after onset of throbbing pain). "Pain reduction" is defined as a subject with a 1 or more point decrease on a 4 point pain scale; (0=None, 1=mild, 2= moderate, 3=severe).
| Participants | Migranal: Early Treatment | Migranal Late Treatment |
|---|---|---|
| Number of Subjects Who Had Pain Relief at 2 Hours Post Treatment With Study Drug. | 14 | 15 |
Collected over Adverse Events collected from time of dosing through 48 hours post dose.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Migranal: All Subjects | — | 0/48 (0%) | 14/48 (29.2%) |
| Event | Migranal: All Subjects |
|---|---|
| nauseaGastrointestinal disorders | 6/48 |
| nasal discomfortRespiratory, thoracic and mediastinal disorders | 5/48 |
| mouth and throat discomfortGeneral disorders | 3/48 |
| Age, Continuous(years) | Migranal: All Subjects |
|---|---|
| Mean | 40.86 ± 10.47 |
| Sex: Female, Male(Participants) | Migranal: All Subjects |
|---|---|
| Female | 53 |
| Male | 11 |
| Region of Enrollment(participants) | Migranal: All Subjects |
|---|---|
| United States | 64 |
The record gives a start of Aug 2006, a primary completion of Dec 2008 and a completion of Apr 2009. It does not say whether these dates are actual or estimated.
Results were first posted in Oct 2011, 2 years 10 months after primary completion.
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This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dihydroergotamine