Clinical trial NCT00335777
Conditions: Migraine
Sponsor: Thomas Jefferson University
Start date: 2006-08-01; Completion date: 2009-04-01
Enrollment: 64 participants; Allocation: NON_RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
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.

Detailed description:
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.

Arms: arm 1: 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). arm 2: 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).
Interventions: intervention 1: Migranal nasal spray at 1 hour intervention 2: Migranal nasal spray at 4 hour
Intervention descriptions: intervention 1: 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. intervention 2: 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.

Protocol documents: