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Caffeine/Propranolol Intervention for Acute Migraine

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ClinicalTrials.gov Identifier: NCT01080677
Recruitment Status : Completed
First Posted : March 4, 2010
Results First Posted : February 24, 2017
Last Update Posted : February 24, 2017
Sponsor:
Information provided by (Responsible Party):
S. Charles Cho, Stanford University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Migraine Disorders
Interventions Drug: caffeine/propranolol combination tablet
Drug: placebo
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Low Dose High Dose
Hide Arm/Group Description Participants received placebo to match caffeine/propranolol (single dose) Participants received caffeine/propranolol 400/40 mg combination tablet (single dose) Participants received caffeine/propranolol 1000/40 mg combination tablet (single dose)
Period Title: Overall Study
Started 20 20 20
Completed 20 20 20
Not Completed 0 0 0
Arm/Group Title Placebo Low Dose High Dose Total
Hide Arm/Group Description Participants received placebo to match caffeine/propranolol (single dose) Participants received caffeine/propranolol 400/40 mg combination tablet (single dose) Participants received caffeine/propranolol 1000/40 mg combination tablet (single dose) Total of all reporting groups
Overall Number of Baseline Participants 20 20 20 60
Hide Baseline Analysis Population Description
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.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 20 participants 60 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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 20 participants 60 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  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 20 participants 20 participants 60 participants
20 20 20 60
1.Primary Outcome
Title 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)
Hide Description [Not Specified]
Time Frame 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Low Dose High Dose
Hide Arm/Group Description:
Participants received placebo to match caffeine/propranolol (single dose)
Participants received caffeine/propranolol 400/40 mg combination tablet (single dose)
Participants received caffeine/propranolol 1000/40 mg combination tablet (single dose)
Overall Number of Participants Analyzed 20 20 20
Measure Type: Number
Unit of Measure: percentage of participants
10 45 60
2.Secondary Outcome
Title Percentage of Participants Pain Free at 2 Hrs Post First Administration of Caffeine/Propranolol
Hide Description [Not Specified]
Time Frame 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Low Dose High Dose
Hide Arm/Group Description:
Participants received placebo to match caffeine/propranolol (single dose)
Participants received caffeine/propranolol 400/40 mg combination tablet (single dose)
Participants received caffeine/propranolol 1000/40 mg combination tablet (single dose)
Overall Number of Participants Analyzed 20 20 20
Measure Type: Number
Unit of Measure: percentage of participants
0 20 35
3.Secondary Outcome
Title Percentage of Participants Experiencing at Least One Adverse Event of Interest
Hide Description Adverse events may have included abdominal pain, flushing, dizziness, insomnia, or anxiety
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Low Dose High Dose
Hide Arm/Group Description:
Participants received placebo to match caffeine/propranolol (single dose)
Participants received caffeine/propranolol 400/40 mg combination tablet (single dose)
Participants received caffeine/propranolol 1000/40 mg combination tablet (single dose)
Overall Number of Participants Analyzed 20 20 20
Measure Type: Number
Unit of Measure: percentage of participants
10 25 50
4.Secondary Outcome
Title Percentage of Participants With Treatment Satisfaction
Hide Description Following up to 24 hours after treatment, participants were asked to report whether they were satisfied with level of pain relief provided by treatment
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Low Dose High Dose
Hide Arm/Group Description:
Participants received placebo to match caffeine/propranolol (single dose)
Participants received caffeine/propranolol 400/40 mg combination tablet (single dose)
Participants received caffeine/propranolol 1000/40 mg combination tablet (single dose)
Overall Number of Participants Analyzed 20 20 20
Measure Type: Number
Unit of Measure: percentage of participants
5 40 80
Time Frame 24 hours
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Low Dose High Dose
Hide Arm/Group Description Participants received placebo to match caffeine/propranolol (single dose) Participants received caffeine/propranolol 400/40 mg combination tablet (single dose) Participants received caffeine/propranolol 1000/40 mg combination tablet (single dose)
All-Cause Mortality
Placebo Low Dose High Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Low Dose High Dose
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/20 (0.00%)      0/20 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Low Dose High Dose
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/20 (20.00%)      5/20 (25.00%)      5/20 (25.00%)    
Gastrointestinal disorders       
abdominal pain   2/20 (10.00%)  2 1/20 (5.00%)  1 1/20 (5.00%)  1
General disorders       
flushing   0/20 (0.00%)  0 1/20 (5.00%)  1 1/20 (5.00%)  1
Nervous system disorders       
dizziness   2/20 (10.00%)  2 1/20 (5.00%)  1 1/20 (5.00%)  1
insomnia   0/20 (0.00%)  0 1/20 (5.00%)  1 1/20 (5.00%)  1
Psychiatric disorders       
anxiety   0/20 (0.00%)  0 1/20 (5.00%)  1 1/20 (5.00%)  1
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Professor of Neurology
Organization: Stanford University School of Medicine
Phone: 650-723-5184
EMail: chos@stanford.edu
Layout table for additonal information
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 )
First Submitted: March 2, 2010
First Posted: March 4, 2010
Results First Submitted: January 28, 2015
Results First Posted: February 24, 2017
Last Update Posted: February 24, 2017