CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 64 enrolled
Drug / intervention
Migranal nasal spray at 1 hour +1 moredrug
Likely dose
Migranal nasal spray at 1 hour 4 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00335777
NCT00335777Phase 4Completed

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

Thomas Jefferson University·interventional·Posted Jun 12, 2006·Updated Mar 11, 2022

In Brief

A Phase 4 clinical trial evaluating Migranal nasal spray at 1 hour and Migranal nasal spray at 4 hour for Migraine. Completed, enrolled 64 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMigraine
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 12, 2006
Enrollment StartAug 1, 2006
Primary CompletionDec 1, 2008
Study CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 20.1 years ago

Interventions

Migranal nasal spray at 1 hourdrug

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.

Migranal nasal spray at 4 hourdrug

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.