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NCT00335777 · ClinicalTrials.gov registry record · Phase 4
A Research Study Examining Migranal and Skin Sensitivity in Subjects With Migraine
A Phase 4 study, sponsored by Thomas Jefferson University.
- Completed
- Registry status
- Phase 4
- Development phase
- 64
- Enrollment target
NCT00335777: Completed Phase 4 study, sponsored by Thomas Jefferson University.
NCT00335777 is a Phase 4 study that has completed, run by Thomas Jefferson University. The registered enrollment target is 64 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00335777, a Phase 4 study, has completed, sponsored by Thomas Jefferson University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 64 participants
- Enrollment target
Study 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.
Primary Outcome
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).
Interventions
- DRUG Migranal nasal spray at 1 hour
- DRUG Migranal nasal spray at 4 hour
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2006-08 |
| Est. Completion | 2009-04 |
| Phase | Phase 4 |
What the finished NCT00335777 record still lists
NCT00335777 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which Migranal nasal spray at 1 hour is the first listed.
NCT00335777 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00335777 about?
NCT00335777 is a clinical study titled "A Research Study Examining Migranal and Skin Sensitivity in Subjects With Migraine". 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 s...
What is the current status of trial NCT00335777?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 64 participants. The study started on 2006-08. Estimated completion is 2009-04.
What interventions are being tested in trial NCT00335777?
The interventions under investigation include: Migranal nasal spray at 1 hour (DRUG), Migranal nasal spray at 4 hour (DRUG).
Who is sponsoring clinical trial NCT00335777?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00335777's enrollment target sits among peer trials
64 1098th of 2000 higher than 895 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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