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| Principal Investigator: | Lawrence Newman , MD | |
| Time frame of study: | Ongoing | |
| Time frame of participation: | 8 weeks | |
| Number of participants needed: | Open | |
| Location of Study: | St.
Luke’s Roosevelt Hospital Center |
|
| Contact Name, Number & Email: | Betty
Liong Study Coordinator 212-523-8562 Bliong@chpnet.org |
Summary:
The purpose of this research study is to evaluate the effectiveness
of the new rapid release formulation of sumatriptan (Imitrex)100mg when
taken early in the migraine process and to evaluate subject satisfaction
with this method of early treatment. It will also evaluate the benefit
of the new rapid release formulation in those subjects who experience
the early changes in skin sensation that start before the migraine pain.
Study Design:
Screening: After obtaining informed consent, subjects will be
given a physical exam that includes a blood draw and the collection of
a full medical history, migraine history and medication history.
Treatment: If you are medically eligible for the study, you will be given sumatriptan 100mg to treat 4 migraine attacks within 8 weeks.
You will be given a paper diary to record your migraine attacks.
Follow up: Within 2 weeks of treating your 4th migraine
or 8 weeks from your screening (whichever comes first), you should contact
the study coordinator to schedule a follow up visit.
Criteria
for Participation:
- Men or women between the ages of 18-65
- Has a 1-year history of migraine with 2-6 migraine attacks per month
- Typically experience moderate to severe migraine pain preceded by a mild pain phase
- Not completely satisfied with current migraine treatment
- Not previously taken sumatriptan 100mg