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A Research Study Examining Migranal and Skin Sensitivity in Subjects With Migraine

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: NCT00335777
Recruitment Status : Completed
First Posted : June 12, 2006
Results First Posted : October 14, 2011
Last Update Posted : April 16, 2014
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Migraine
Intervention Drug: Migranal nasal spray
Enrollment 64
Recruitment Details Participants were recruited from our office practice or surrounding community and screened at the Jefferson Headache Center between 8/21/06 and 6/18/08.
Pre-assignment Details Eligible subjects were enrolled in the study and dispensed open label study medication at the end of the screening visit.
Arm/Group Title Migranal: All Subjects
Hide Arm/Group Description All subjects enrolled in study
Period Title: Enrolled and Dispensed Study Medication
Started 64 [1]
Completed 35
Not Completed 29
Reason Not Completed
Lost to Follow-up             5
Withdrawal by Subject             6
Treated only 1 or no headaches             18
[1]
64 subjects enrolled. 35 treated 2 headaches, but 22/35 at appropriate times, as per protocol.
Period Title: Treated 2 Headaches Per Protocol
Started 35
Completed 22
Not Completed 13
Reason Not Completed
Treated 2 early or 2 late headaches             1
Treated 1 early and 1 late out of protoc             12
Arm/Group Title Migranal: All Subjects
Hide Arm/Group Description All subjects enrolled in study
Overall Number of Baseline Participants 64
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 64 participants
40.86  (10.47)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants
Female
53
  82.8%
Male
11
  17.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 64 participants
64
1.Primary Outcome
Title Number of Subjects Who Were Pain Free at 2 Hours Post Treatment With Study Drug.
Hide Description Number of subjects who were pain free at 2 hours after treatment with study medication when they treated a migraine early (defined as treatment within 1 hour of onset of throbbing pain) compared to the number of subjects who were pain free at 2 hours after treatment with study medication when they treated late (defined as 4 hours after onset of throbbing pain). "Pain free" is defined as a subject rating of zero on a 4 point pain scale; (0=None, 1=mild, 2= moderate, 3=severe).
Time Frame 2 hours post treatment with study medication
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population was used in the efficacy analyses. 22 subjects were included, since they treated a migraine early and another migraine late, as defined in the protocol, with study medication.(Cross-over design)
Arm/Group Title Migranal: Early Treatment Migranal Late Treatment
Hide Arm/Group Description:
Treated headache within 1.25 hours of onset of throbbing
Treated a headache at greater or equal to 3.5 hours after onset of throbbing
Overall Number of Participants Analyzed 22 22
Measure Type: Number
Unit of Measure: participants
4 8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Migranal: Early Treatment, Migranal Late Treatment
Comments Null hypothesis: there is no difference in the proportion of subjects who had pain relief when treating early, as compared to treating late.
Type of Statistical Test Non-Inferiority or Equivalence
Comments 2 sided McNemar test
Statistical Test of Hypothesis P-Value 0.289
Comments [Not Specified]
Method McNemar
Comments 2 sided McNemar
2.Secondary Outcome
Title Allodynia Assessments as Performed at Pre-dosing, 15 Minutes, 30 Minutes, 1 Hour, 1 ½ Hours, 2 Hours, 4 Hours, 8 Hours and 24 Hours Post-dosing for Each Attack Treated Per Subject. Post-dosing Assessments Begin After the Entire 4mg. Dose Has Been Adminis
Hide Description [Not Specified]
Time Frame baseline, 15 minutes, 30 min., 1 hr., 1.5 hr, 2 hr, 4 hr, 8 hr, 24 hr
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Pain and Associated Symptoms Assessments as Measured at Pre-dose, 15 Minutes, 30 Minutes, 1 Hour, 1 ½ Hours, 2 Hours, 4 Hours, 8 Hours and 24 Hours Post-dosing for Each Attack Treated Per Subject. Post-dosing Assessments Begin After the Entire 4mg. Dose
Hide Description [Not Specified]
Time Frame baseline, 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 4 hr. 8 hr, 24 hr
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Subjects Historical Response to Triptan Therapy and Ergot Therapies
Hide Description [Not Specified]
Time Frame baseline
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Use of Rescue Therapy for Each Attack Treated Per Subject
Hide Description [Not Specified]
Time Frame number subjects using rescue used between 2 and 24 hrs after study drug
Outcome Measure Data Not Reported
Time Frame Adverse Events collected from time of dosing through 48 hours post dose.
Adverse Event Reporting Description Adverse Event assessments were performed on ALL subjects who took any study medication, even if they did not treat according to the guidelines in the protocol. N=48
 
Arm/Group Title Migranal: All Subjects
Hide Arm/Group Description All subjects enrolled in study
All-Cause Mortality
Migranal: All Subjects
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Migranal: All Subjects
Affected / at Risk (%)
Total   0/48 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Migranal: All Subjects
Affected / at Risk (%)
Total   14/48 (29.17%) 
Gastrointestinal disorders   
nausea *  6/48 (12.50%) 
General disorders   
mouth and throat discomfort *  3/48 (6.25%) 
Respiratory, thoracic and mediastinal disorders   
nasal discomfort * [1]  5/48 (10.42%) 
*
Indicates events were collected by non-systematic assessment
[1]
nasal burning, stuffiness or discomfort
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Stephen D. Silberstein, MD
Organization: Jefferson Headache Center
Phone: 215-955-2243
Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00335777     History of Changes
Other Study ID Numbers: SDS/MIG-CA/ 01
First Submitted: June 9, 2006
First Posted: June 12, 2006
Results First Submitted: October 26, 2010
Results First Posted: October 14, 2011
Last Update Posted: April 16, 2014