Caffeine/Propranolol Acute Migraine
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
Migraine Disorders |
Drug: caffeine propranolol combination |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Randomized Double-Blind Study to Evaluate the Dose-Related Efficacy and Safety of Caffeine/Propranolol in the Treatment of Acute Migraine |
- 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) [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
- Pain free at 2 hrs post first administration of caffeine/propranolol [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
- Relief of associated symptoms such as nausea, and photophobia and phonophobia at 2 hours [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
- Safety and tolerability [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
- Subject treatment satisfaction [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
- Lack of need for rescue medication [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
| Enrollment: | 60 |
| Study Start Date: | January 2007 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| United States, California | |
| Stanford University School of Medicine | |
| Stanford, California, United States, 94305 | |
| Principal Investigator: | S. Charles Cho | Stanford University |
More Information
No publications provided
| Responsible Party: | S. Charles Cho, Stanford University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01080677 History of Changes |
| Other Study ID Numbers: | SU-02112010-4963, 7011 |
| Study First Received: | March 2, 2010 |
| Last Updated: | March 2, 2010 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Migraine Disorders Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Caffeine Propranolol Central Nervous System Stimulants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Phosphodiesterase Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Purinergic P1 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Anti-Arrhythmia Agents Cardiovascular Agents Antihypertensive Agents Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Vasodilator Agents |
ClinicalTrials.gov processed this record on May 23, 2013