Migraine Disorders Clinical Trial
Official title:
Randomized Double-Blind Study to Evaluate the Dose-Related Efficacy and Safety of Caffeine/Propranolol in the Treatment of Acute Migraine
This is a research study to assess the safety of caffeine/propranolol at different dose levels. We want to find out what effects, good and/or bad, it has on patients and their migraines.
There will be a screening exam to find out if potential subjects are eligible to be in the
main part of the study. Screening will include obtaining demographics, migraine history,
migraine characteristics, verification that subjects's migraine satisfies the International
Headache Society criteria, migraine medication history with success and failure rates, and
medical history.
If a subject is female, we will need to confirm to the extent medically possible that they
are not pregnant. Female subjects must agree to have a urine pregnancy test done before
beginning this research study. If a subject is a woman who is able to become pregnant, it is
expected that they will use an effective method of birth control to prevent exposing a fetus
to a potentially dangerous agent with unknown risk. They must accept the risk that pregnancy
could still result despite the responsible use of reliable method of birth control.
They agree to notify Dr. Cho as soon as possible of any failure of proper use of your birth
control method, or if you become pregnant, either of which may result in your being
withdrawn from the study.
Subjects will also undergo a liver function test as well as an EKG to make sure they are
eligible for the study.
Once subject eligibility has been determined, they will be randomized to one of 3 study
groups described below. Neither the subjects nor the doctor can choose which group subjects
will be in nor will subjects or their doctor know which group subjects are in. They will
have a one in three chance of being placed in any group. Two groups will be active treatment
with either 400 mg caffeine and 40 mg propranolol or 1000 mg caffeine and 40 mg propranolol.
The third group will be a placebo group with no active medication.
Subjects will then be given a study kit, which includes caffeine/propranolol or placebo oral
medication, a treatment booklet, migraine headache diary, pen and stopwatch. The study
coordinator will then instruct them in the accurate method of diary completion and use of
the oral medication or placebo pill. Their final visit will be scheduled within 60 days of
enrollment.
They will be instructed to treat one moderate or severe migraine attack with the study
medication. They will be instructed to take study medication at aura onset in the presence
of another adult.
In the absence of any aura, they will be instructed to take study medication at headache
onset. Another adult should be present when taking the study medication to ensure safety. In
the event that the migraine occurs while they are alone, the subjects are instructed not to
take the study medication and to wait for the next headache when adult supervision is
available. They will not be allowed to use any non-steroidal,anti-inflammatory drugs such as
ibuprofen or naproxen sodium, non-prescription analgesics such as acetaminophen or aspirin,
narcotic analgesics such as oxycontin, oxycodone, triptan or ergotamine medication or
derivatives (Cafergot®, D.H.E., 45®[dihydroergotamine mesylate], Efcaf®, Ergomar®,
Ergostat®, Migranal®, Nasal Spray, Sansert®[methysergide], or Wigraine®) within 24 hours
prior to dosing with the study medication. Subjects will also be instructed not to use any
caffeine such as coffee, tea, caffeine containing sodas, or caffeine containing medications
(Cafcit®, Caffedrine®, Enerjets, Lucidex, No Doz® Maximum Strength, Vivarin®) within 6 hours
prior to dosing with the study medication.
Subjects will record the severity of their headache and associated symptoms at baseline and
15, 30, 45, 60, and 120 minutes after dosing. If the migraine does not resolve or worsens
after 2 hours, they will be allowed to take #rescue medication# as prescribed by their
physician. Subjects will continue to record the severity of their headache and associated
symptoms for 4, 12, and 24 hours after initial dosing. Following the last entry in the
subject diary at 24 hours, they will be asked to complete a treatment satisfaction
questionnaire. They will also be asked to contact Dr. Cho#s office to review their diary
completion and to confirm the date of their final visit.
If subjects have not called to report a migraine within a month (±7 days) of enrollment, Dr.
Cho or someone from his research staff will call them to determine if they have treated a
migraine. If a migraine was treated, Dr. Cho or the study staff will interview them to
determine if the diary has been appropriately completed and to ensure that adequate
information has been recorded. Their final visit will be confirmed and should occur within
30 days of the treated migraine. If they have not treated a migraine with the study
medication within the first 30 days of enrollment, their final visit will be rescheduled
within 60 days of your enrollment date (± 7 days).
At the final visit, the study coordinator will review their subject diary for completeness
and accuracy. All study materials will need to be returned at this visit. Subjects will then
have a second EKG to make sure the medication didn't have any negative effects on their
cardiac function. Subjects will be given a voucher to pay for parking expenses. In addition,
there will be a data safety monitoring unblinding event after the first 15 patients have
completed the study. All serious and non-serious adverse events will be analyzed regardless
of the investigators' assessments of causality. Adverse events that result in death,
hospitalization, permanent disability or threat to life are classified as serious. The
Medical Dictionary of Regulatory Activities (MedDRA) will be used to categorize reported
adverse events. Someone who is not directly related to the research team will conduct the
safety monitoring.
If there are any serious adverse events during the study, the study will be discontinued.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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