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Tracking Information | |||||||||
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First Received Date † | June 9, 2006 | ||||||||
Last Updated Date | October 11, 2006 | ||||||||
Start Date † | |||||||||
Current Primary Outcome Measures † |
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Original Primary Outcome Measures † | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT00335777 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||||||
Descriptive Information | |||||||||
Brief Title † | A Research Study Examining Migranal and Skin Sensitivity in Subjects With Migraine | ||||||||
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 | ||||||||
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. |
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Detailed Description | |||||||||
Study Phase | Phase IV | ||||||||
Study Type † | Interventional | ||||||||
Study Design † | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study | ||||||||
Condition † | Migraine | ||||||||
Intervention † | Drug: Migranal | ||||||||
Study Arms / Comparison Groups | |||||||||
Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status † | Recruiting | ||||||||
Enrollment † | |||||||||
Completion Date | |||||||||
Primary Completion Date | |||||||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||
Ages | 18 Years to 65 Years | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts †† |
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Location Countries † | United States | ||||||||
Expanded Access Status | |||||||||
Administrative Information | |||||||||
NCT ID † | NCT00335777 | ||||||||
Responsible Party | |||||||||
Secondary IDs †† | |||||||||
Study Sponsor † | Thomas Jefferson University | ||||||||
Collaborators †† | |||||||||
Investigators † |
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Information Provided By | Thomas Jefferson University | ||||||||
Verification Date | October 2006 | ||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |