Caffeine/Propranolol Intervention for Acute Migraine

Not Recruiting

Trial ID: NCT01080677


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.

Official Title

Randomized Double-Blind Study to Evaluate the Dose-Related Efficacy and Safety of Caffeine/Propranolol in the Treatment of Acute Migraine

Stanford Investigator(s)

S. Charles Cho, MD
S. Charles Cho, MD

Clinical Professor, Neurology & Neurological Sciences Clinical Professor (By courtesy), Neurosurgery


Inclusion Criteria:1. Subject has a minimum 12-month migraine history that the investigator
determines meets the International Headache Society (IHS) Migraine Diagnostic Criteria for
migraine with or without aura 2. Subject is between 18-50 years of age. 3. Subject
experiences an average of 2-8 migraines per month. 4. If on preventive migraine therapy,
medication regimen has been stable for 30 days and will remain stable for the duration of

5. Subject is able to communicate adequately and comply with the requirements of the study
as determined by the investigator.

6. Subject is able to read and understand the informed consent written in English and
voluntarily consents to sign the informed consent form.

Exclusion Criteria:1. Subject#s age of migraine onset is greater than 50 years. 2. Subject
has more than 6 non-migraine headache days per month. 3. Subject has less than 48 hours of
freedom from headache between attacks of migraine.

4. Subject meets the criteria for complicated and/or brainstem migraines. 5. Subject is
pregnant or lactating. 6. Subject has history of alcohol or drug abuse within the past 2
years. 7. Subject has existing systolic blood pressure < 100mm Hg, existing systolic blood
pressure > 150mm Hg, and or heart rate <50 beats per minute.

8. Subject has heart block greater than 1st degree without a functioning pacemaker 9.
Subject has a history of tachyarrythmias 10. Subject has uncompensated congestive heart
failure (CHF) 11. Subject has severe chronic obstructive pulmonary disease or severe
asthma. 12. Subject has consumed caffeine within 6 hours. 13. Subjects with existing
generalized anxiety disorder (GAD) and/or panic disorder.

14. Subjects with existing severe hepatic and/or renal insufficiency. 15. Subjects with
existing Raynaud#s disease. 16. Subject is participating in another clinical trial during
or within 30 days prior to study enrollment.


drug: caffeine/propranolol combination tablet

drug: placebo

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
S. Charles Cho