Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Valeant Pharmaceuticals International, Inc.
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00203268
First received: September 13, 2005
Last updated: May 8, 2014
Last verified: May 2014
Results First Received: October 25, 2010  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Migraine
Intervention: Drug: dihydroergotamine mesylate

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Treatment Group 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

Participant Flow for 2 periods

Period 1:   Early Treatment
    Treatment Group  
STARTED     13  
COMPLETED     9  
NOT COMPLETED     4  
only treated one headache                 2  
Lost to Follow-up                 1  
Withdrawal by Subject                 1  

Period 2:   Late Treatment
    Treatment Group  
STARTED     9  
COMPLETED     9  
NOT COMPLETED     0  



  Baseline Characteristics
  Hide Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Treatment Group 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.

Baseline Measures
    Treatment Group  
Number of Participants  
[units: participants]
  13  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     13  
>=65 years     0  
Gender  
[units: participants]
 
Female     13  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     13  



  Outcome Measures

1.  Primary:   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.   [ Time Frame: 2 hours post treatment and 4 hours post treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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
e-mail: Stephen.Silberstein@Jefferson.edu


No publications provided


Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00203268     History of Changes
Other Study ID Numbers: SDS/DHE/01
Study First Received: September 13, 2005
Results First Received: October 25, 2010
Last Updated: May 8, 2014
Health Authority: United States: Food and Drug Administration