A Research Study Examining Migranal and Skin Sensitivity in Subjects With Migraine

Condition(s) targeted: Migraine

Intervention: Migranal (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Thomas Jefferson University

Official(s) and/or principal investigator(s):
Stephen D. Silberstein, M.D., Principal Investigator, Affiliation: Jefferson Headache Center

Overall contact:
Aamir Hussain, M.D., Phone: 215-955-2243, Email: aamirgul@gmail.com

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.

Official title: An Open-Label Pilot Trial To Collect And Evaluate Data On The Use Of Migranal® In The Treatment Of Two Acute Migraine Attacks Associated With Cutaneous Allodynia

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome:

. State the primary objective(s) of the study

The specific aim is to describe the difference, if any, in subjects who treat a migraine attack early (at 1 hour) with Migranal and those who treat later (at 4-hours) and relate this to the presence or absence of established cutaneous allodynia.

Secondary outcome:

b. State the secondary objectives(s) of the study

Allodynia assessments as performed at pre-dosing, 15 minutes, 30 minutes, 1 hour, 1 ½ hours, 2 hours, 4 hours, 8 hours and 24 hours post-dosing for each attack treated per subject. Post-dosing assessments begin after the entire 4mg. dose has been adminis

Pain and associated symptoms assessments as measured at pre-dose, 15 minutes, 30 minutes, 1 hour, 1 ½ hours, 2 hours, 4 hours, 8 hours and 24 hours post-dosing for each attack treated per subject. Post-dosing assessments begin after the entire 4mg. dose

Subjects historical response to triptan therapy and ergot therapies

Occurrence of adverse events for each attack treated per subject

Use of rescue therapy for each attack treated per subject

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male and female subjects between the ages of 18 and 65, inclusive

- Subjects diagnosed with episodic migraine, with or without aura according to IHS

criteria (Appendix B) for at least one-year prior to screening

- Subjects who experience between 3-10 migraine attacks (inclusive) per month (during

the previous 6 months) with no more than 15 days of headache per month.

- Subjects who report their migraine pain quality as pulsating/ throbbing.

- Subject experiences episodic migraine associated with cutaneous allodynia, as

determined by the Cutaneous Allodynia screening tool and investigator.

- Subject is using or agrees to use for the duration of participation a medically

acceptable form of contraception (as determined by investigator), if female of child-bearing potential

- Subjects who are able to understand and comply with all study procedures.

- Subject provides written informed consent prior to any screening procedures being

conducted

Exclusion Criteria:

- Pregnant and/or lactating women

- Subjects who, in the investigators opinion, have a history or have evidence of a

medical or psychiatric condition that would expose them to an increased risk of a significant adverse event or would interfere with the assessments of efficacy and tolerability during this trial

- Subjects with an abnormal ECG that, in the investigators opinion, would expose them

to increased risk of adverse events or interfere with study drug and/or analysis of efficacy/tolerability

- Subjects currently using, or expecting to use during the trial, CYP 3A4 inhibitors

(such as protease inhibitors and macrolide antibiotics)

- Subjects with severely impaired hepatic or renal function, as determined by the

investigator

- Subjects who have participated in an investigational drug trial in the 30 days prior

to the screening visit

- Subjects who currently have or have a history of basilar or hemiplegic migraine

- Subjects who have previously shown hypersensitivity to ergot alkaloids

- Subjects who have a history of non-response to DHE-45 or Migranal®, as determined by

investigator

- Subjects with uncontrolled hypertension

- Subjects who currently have or who have a history of ischemia and/or vasospastic

coronary artery disease

- Subjects who, in the investigators opinion, have significant risk factors of coronary

artery disease

Aamir Hussain, M.D., Phone: 215-955-2243, Email: aamirgul@gmail.com

Jefferson Headache Center, Philadelphia, Pennsylvania 19107, United States; Recruiting
Stephen D. Silberstein, M.D., Principal Investigator

Last updated: October 11, 2006