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
Verified date | March 2010 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | December 2009 |
Est. primary completion date | September 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria:1. Subject has a minimum 12-month migraine history that the
investigator determines meets the 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. 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 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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Stanford University School of Medicine | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain-relief at 2 hrs post first administration of caffeine/propranolol (defined as a decrease in headache pain intensity from severe or moderate headache pain at baseline to mild or no pain at 2 hrs) | 2 hours | No | |
Secondary | Pain free at 2 hrs post first administration of caffeine/propranolol | 2 hours | No | |
Secondary | Relief of associated symptoms such as nausea, and photophobia and phonophobia at 2 hours | 2 hours | No | |
Secondary | Safety and tolerability | 24 hours | Yes | |
Secondary | Subject treatment satisfaction | 24 hours | No | |
Secondary | Lack of need for rescue medication | 24 hours | No |
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