Caffeine/Propranolol Intervention for Acute Migraine

Trial ID or NCT#

NCT01080677

Status

not recruiting iconNOT RECRUITING

Purpose

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

Eligibility Criteria

Ages Eligible for Study: 18 Years to 50 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Yes
Inclusion Criteria:
  1. 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 participation. 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. 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.

Investigator(s)

S. Charles Cho, MD
S. Charles Cho, MD
Neuromuscular neurologist, Neurophysiologist
Clinical Professor, Neurology & Neurological Sciences Clinical Professor (By courtesy), Neurosurgery

Contact us to find out if this trial is right for you.

Contact

S. Charles Cho
6507235184