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Caffeine/Propranolol Intervention for Acute Migraine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
S. Charles Cho, Stanford University
ClinicalTrials.gov Identifier:
NCT01080677
First received: March 2, 2010
Last updated: January 4, 2017
Last verified: January 2017
  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 tablet Drug: placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
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

Resource links provided by NLM:


Further study details as provided by S. Charles Cho, Stanford University:

Primary Outcome Measures:
  • 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) [ Time Frame: 2 hours ]

Secondary Outcome Measures:
  • Percentage of Participants Pain Free at 2 Hrs Post First Administration of Caffeine/Propranolol [ Time Frame: 2 hours ]
  • Percentage of Participants Experiencing at Least One Adverse Event of Interest [ Time Frame: 24 hours ]
    Adverse events may have included abdominal pain, flushing, dizziness, insomnia, or anxiety

  • Percentage of Participants With Treatment Satisfaction [ Time Frame: 24 hours ]
    Following up to 24 hours after treatment, participants were asked to report whether they were satisfied with level of pain relief provided by treatment


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)
Arms Assigned Interventions
Placebo Comparator: Placebo
Participants will receive placebo to match caffeine/propranolol (single dose)
Drug: placebo
placebo to match caffeine/propranolol combination tablet administered orally once daily
Experimental: Low dose
Participants will receive caffeine/propranolol 400/40 mg combination tablet (single dose)
Drug: caffeine/propranolol combination tablet
caffeine/propranolol combination tablet administered orally once daily
Experimental: High dose
Participants will receive caffeine/propranolol 1000/40 mg combination tablet (single dose)
Drug: caffeine/propranolol combination tablet
caffeine/propranolol combination tablet administered orally once daily

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01080677

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: S. Charles Cho Stanford University
  More Information

Responsible Party: S. Charles Cho, Principle Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT01080677     History of Changes
Other Study ID Numbers: SU-02112010-4963
7011 ( Other Grant/Funding Number: Palo Alto Institute/Stanford University )
Study First Received: March 2, 2010
Results First Received: January 28, 2015
Last Updated: January 4, 2017

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
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on August 23, 2017