Caffeine/Propranolol Acute Migraine

This study has been completed.
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT01080677
First received: March 2, 2010
Last updated: NA
Last verified: March 2010
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Criteria

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
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

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 April 15, 2014