Phase 2 N=60 Randomized Double-blind Treatment

Caffeine/Propranolol Intervention for Acute Migraine

Migraine Disorders

Bottom Line

View on ClinicalTrials.gov: NCT01080677 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2017

Primary outcome: Primary: Percentage of Participants Reporting 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) — 10; 45; 60 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: caffeine/propranolol combination tablet (Drug); placebo (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Stanford University
Primary completion: Sep 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants Reporting 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)	10; 45; 60	—
SECONDARY Percentage of Participants Pain Free at 2 Hrs Post First Administration of Caffeine/Propranolol	0; 20; 35	—
SECONDARY Percentage of Participants Experiencing at Least One Adverse Event of Interest	10; 25; 50	—
SECONDARY Percentage of Participants With Treatment Satisfaction	5; 40; 80	—

Summary

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.

Eligibility Criteria

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 participation.

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

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 150mm Hg, and or heart rate <50 beats per minute.
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.
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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01080677). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.