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Trial record 4 of 42 for:    FROVATRIPTAN

A Research Study To Evaluate If Frovatriptan Is Safe And Effective In Preventing Migraine Headache After Fasting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00440232
Recruitment Status : Completed
First Posted : February 26, 2007
Results First Posted : November 18, 2010
Last Update Posted : May 26, 2011
Sponsor:
Information provided by:
Thomas Jefferson University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Migraine
Interventions Drug: Frovatriptan
Drug: Placebo
Enrollment 74
Recruitment Details Eligible participants were recruited from our office practice or surrounding community from 7/16/07 through 3/18/09
Pre-assignment Details  
Arm/Group Title Frovatriptan Placebo
Hide Arm/Group Description 5.0 mg of Frovatriptan given as single dose [Not Specified]
Period Title: Overall Study
Started 36 38
Completed 33 34
Not Completed 3 4
Reason Not Completed
Lost to Follow-up             1             1
Unable to treat within allowed time             0             1
Onset of headache within 4 hours of fast             2             2
Arm/Group Title Frovatriptan Placebo Total
Hide Arm/Group Description 5.0 mg of Frovatriptan given as single dose [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 36 38 74
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 38 participants 74 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
36
 100.0%
38
 100.0%
74
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants 38 participants 74 participants
40.15  (11.8) 38.7  (12.7) 39.49  (12.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 38 participants 74 participants
Female
28
  77.8%
30
  78.9%
58
  78.4%
Male
8
  22.2%
8
  21.1%
16
  21.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 36 participants 38 participants 74 participants
36 38 74
1.Primary Outcome
Title Incidence of Fasting-induced Headache of Any Intensity
Hide Description Incidence of fasting-induced headache of any intensity occurring at greater than 4 hours, but within 20 hours after onset of fasting
Time Frame 20 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Frovatriptan Placebo
Hide Arm/Group Description:
5.0 mg of Frovatriptan given as single dose
[Not Specified]
Overall Number of Participants Analyzed 33 34
Measure Type: Number
Unit of Measure: participants
12 18
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Frovatriptan, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.172
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.969
Confidence Interval (2-Sided) 95%
0.74 to 5.235
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Time to Development of Headache of Any Intensity
Hide Description Time to development of headache of any intensity in the 2 treatment arms
Time Frame 20 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Frovatriptan Placebo
Hide Arm/Group Description:
5.0 mg of Frovatriptan given as single dose
[Not Specified]
Overall Number of Participants Analyzed 33 34
Mean (95% Confidence Interval)
Unit of Measure: hours
17.388
(16.05 to 18.73)
17.06
(15.72 to 18.40)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Frovatriptan, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.264
Comments [Not Specified]
Method Log Rank
Comments df=1
Method of Estimation Estimation Parameter log rank chi square
Estimated Value 1.247
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Frovatriptan Placebo
Hide Arm/Group Description 5.0 mg of Frovatriptan given as single dose [Not Specified]
All-Cause Mortality
Frovatriptan Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Frovatriptan Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/35 (0.00%)      0/36 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Frovatriptan Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/35 (2.86%)      5/36 (13.89%)    
Gastrointestinal disorders     
nausea [1]  0/35 (0.00%)  0 3/36 (8.33%)  3
General disorders     
sleepiness/fatigue  1/35 (2.86%)  1 2/36 (5.56%)  2
[1]
Nausea (may be secondary to study medication or associated symptom of migraine)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Stephen D. Silberstein, M.D.
Organization: Jefferson Headache Center/Thomas Jefferson University
Phone: 215-955-2243
EMail: stephen.silberstein@jefferson.edu
Layout table for additonal information
Responsible Party: Stephen D. Silberstein, M.D., Jefferson Headache Center, Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00440232     History of Changes
Other Study ID Numbers: SDS/FHA-FRV/ 01
First Submitted: February 22, 2007
First Posted: February 26, 2007
Results First Submitted: October 26, 2010
Results First Posted: November 18, 2010
Last Update Posted: May 26, 2011