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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
Results First Received: January 28, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Migraine Disorders
Interventions: Drug: caffeine/propranolol combination tablet
Drug: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Placebo Participants received placebo to match caffeine/propranolol (single dose)
Low Dose Participants received caffeine/propranolol 400/40 mg combination tablet (single dose)
High Dose Participants received caffeine/propranolol 1000/40 mg combination tablet (single dose)

Participant Flow:   Overall Study
    Placebo   Low Dose   High Dose
STARTED   20   20   20 
COMPLETED   20   20   20 
NOT COMPLETED   0   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Thirty females, thirty males, agews ranged from 18-50 years old. All had an established history of migraines for at least 1 year. All met the diagnostic criteria of the International Classification of Headache Disorders.

Reporting Groups
  Description
Placebo Participants received placebo to match caffeine/propranolol (single dose)
Low Dose Participants received caffeine/propranolol 400/40 mg combination tablet (single dose)
High Dose Participants received caffeine/propranolol 1000/40 mg combination tablet (single dose)
Total Total of all reporting groups

Baseline Measures
   Placebo   Low Dose   High Dose   Total 
Overall Participants Analyzed 
[Units: Participants]
 20   20   20   60 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      15  75.0%      15  75.0%      15  75.0%      45  75.0% 
>=65 years      5  25.0%      5  25.0%      5  25.0%      15  25.0% 
Gender 
[Units: Participants]
Count of Participants
       
Female      10  50.0%      10  50.0%      10  50.0%      30  50.0% 
Male      10  50.0%      10  50.0%      10  50.0%      30  50.0% 
Region of Enrollment 
[Units: Participants]
       
United States   20   20   20   60 


  Outcome Measures
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1.  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)   [ Time Frame: 2 hours ]

2.  Secondary:   Percentage of Participants Pain Free at 2 Hrs Post First Administration of Caffeine/Propranolol   [ Time Frame: 2 hours ]

3.  Secondary:   Percentage of Participants Experiencing at Least One Adverse Event of Interest   [ Time Frame: 24 hours ]

4.  Secondary:   Percentage of Participants With Treatment Satisfaction   [ Time Frame: 24 hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Professor of Neurology
Organization: Stanford University School of Medicine
phone: 650-723-5184
e-mail: chos@stanford.edu



Responsible Party: S. Charles Cho, 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