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A Study Examining the Use of a Migraine Medicine in the Treatment of Two Migraine Attacks in Patients Who Have Increased Skin Sensitivity

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ClinicalTrials.gov Identifier: NCT00203268
Recruitment Status : Completed
First Posted : September 20, 2005
Results First Posted : June 9, 2014
Last Update Posted : June 9, 2014
Sponsor:
Collaborator:
Bausch Health Americas, Inc.
Information provided by (Responsible Party):
Thomas Jefferson University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Migraine
Intervention Drug: dihydroergotamine mesylate
Enrollment 13
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment Group
Hide Arm/Group Description Subjects who treated a moderate to severe migraine at 1 hour and at 4 hours after the onset of throbbing pain. Subjects were treated with dihydroergotamine mesylate 1.0 mg. intramuscular (IM). Headache severity was rated by subjects using a 4 point scale : 0=None, 1=mild, 2=moderate, 3=severe
Period Title: Early Treatment
Started 13
Completed 9
Not Completed 4
Reason Not Completed
only treated one headache             2
Lost to Follow-up             1
Withdrawal by Subject             1
Period Title: Late Treatment
Started 9
Completed 9
Not Completed 0
Arm/Group Title Treatment Group
Hide Arm/Group Description Subjects who treated a moderate to severe migraine 2 hours and 4 hours after the onset of throbbing pain. Subjects were treated with dihydroergotamine mesylate 1.0 mg. IM. Headache severity was rated by subjects using a 4 point scale : 0=None, 1=mild, 2=moderate, 3=severe.
Overall Number of Baseline Participants 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
<=18 years
0
   0.0%
Between 18 and 65 years
13
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
13
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants
13
1.Primary Outcome
Title Number of Subjects Reporting Headache Relief at the 2 Hour Post Treatment Assessment. Relief Was Measured as a 2-point Change on a 4-point Scale (0=None, 1=Mild, 2=Moderate, 3=Severe)in Both the Early Treatment and Late Treatment Groups.
Hide Description Data was collected at 2 hours post treatment to assess pain level. This assessment was done when subjects treated a migraine early (defined as treatment at 2 hours after onset of throbbing pain)and then late (defined as treatment at 4 hours after onset of throbbing pain). The proportion of subjects reporting headache relief at the 2 hour post treatment assessment was determined for each group and then compared.
Time Frame 2 hours post treatment and 4 hours post treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Early Treatment Late Treatment
Hide Arm/Group Description:
Subjects who treated a moderate to severe migraine 2 hours after the onset of throbbing pain. Subjects were treated with dihydroergotamine mesylate 1.0 mg. IM. Headache severity was rated by subjects using a 4 point scale : 0=None, 1=mild, 2=moderate, 3=severe.
Subjects who treated a moderate to severe migraine 4 hours after the onset of throbbing pain. Subjects were treated with dihydroergotamine mesylate 1.0 mg. IM. Headache severity was rated by subjects using a 4 point scale : 0=None, 1=mild, 2=moderate, 3=severe
Overall Number of Participants Analyzed 9 9
Measure Type: Number
Unit of Measure: participants
2 hours post dose 6 5
4 hours post dose 6 7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Treatment, Late Treatment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .3025
Comments [Not Specified]
Method clustered survival analysis
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Early Treatment Late Treatment
Hide Arm/Group Description Subjects who treated a moderate to severe migraine 2 hours after the onset of throbbing pain. Subjects were treated with dihydroergotamine mesylate 1.0 mg. IM. Headache severity was rated by subjects using a 4 point scale : 0=None, 1=mild, 2=moderate, 3=severe. Subjects who treated a moderate to severe migraine 4 hours after the onset of throbbing pain. Subjects were treated with dihydroergotamine mesylate 1.0 mg. IM. Headache severity was rated by subjects using a 4 point scale : 0=None, 1=mild, 2=moderate, 3=severe
All-Cause Mortality
Early Treatment Late Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Early Treatment Late Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/13 (0.00%)      0/13 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Early Treatment Late Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/9 (33.33%)      3/9 (33.33%)    
Gastrointestinal disorders     
nausea * 2  2/9 (22.22%)  2 2/9 (22.22%)  2
Musculoskeletal and connective tissue disorders     
muscle spasm, quadricep *  2/9 (22.22%)  2 2/9 (22.22%)  2
Nervous system disorders     
Medicinal taste aversion * 3  1/9 (11.11%)  1 1/9 (11.11%)  1
Skin and subcutaneous tissue disorders     
burning at injection site * 1  3/9 (33.33%)  3 3/9 (33.33%)  3
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, burning
2
Term from vocabulary, Nausea
3
Term from vocabulary, taste aversion
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Stephen D. Silberstein, MD
Organization: Thomas Jefferson University
Phone: 215-955-2243
Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00203268     History of Changes
Other Study ID Numbers: SDS/DHE/01
First Submitted: September 13, 2005
First Posted: September 20, 2005
Results First Submitted: October 25, 2010
Results First Posted: June 9, 2014
Last Update Posted: June 9, 2014