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Evaluation of Treatment Satisfaction and Preference for Sumavel DosePro in the Treatment of Migraine

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ClinicalTrials.gov Identifier: NCT01016834
Recruitment Status : Completed
First Posted : November 20, 2009
Results First Posted : December 29, 2011
Last Update Posted : December 29, 2011
Sponsor:
Collaborator:
Synteract, Inc.
Information provided by (Responsible Party):
Zogenix, Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Migraine
Interventions Device: Sumavel DosePro
Drug: Sumatriptan
Enrollment 246
Recruitment Details Recruitment period occured from November, 2009 to February, 2010 at 22 US medical clinics
Pre-assignment Details  
Arm/Group Title Sumavel DosePro
Hide Arm/Group Description The primary study endpoint was overall subject satisfaction with Sumavel DosePro, based on a comparison of the subject’s self-reported answer to the single overall satisfaction question completed at the beginning of the study based on his or her pre-study triptan treatment versus at the end of their treatment period.
Period Title: Overall Study
Started 242
Completed 220
Not Completed 22
Arm/Group Title Sumavel DosePro
Hide Arm/Group Description The primary study endpoint was overall subject satisfaction with Sumavel DosePro, based on a comparison of the subject’s self-reported answer to the single overall satisfaction question completed at the beginning of the study based on his or her pre-study triptan treatment versus at the end of their treatment period.
Overall Number of Baseline Participants 242
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 242 participants
<=18 years
0
   0.0%
Between 18 and 65 years
242
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 242 participants
Female
196
  81.0%
Male
46
  19.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 242 participants
242
1.Primary Outcome
Title Overall Satisfaction
Hide Description Change from baseline in overall subject satisfaction with migraine treatments. Patient Perception of Migraine Questionnaire-Revised, question 3c "Overall satisfaction" was the measure. Baseline measured subjects satisfaction with past migraine treatments. End of study measured subject's satisfaction with migraine treatment by Sumavel DosePro. PPMQ-R scale (1-7 scale; 1=very satisfied)is transformed to a 0-100 scale (100=very satisfied)
Time Frame After 4 migraines or 60 days
Hide Outcome Measure Data
Hide Analysis Population Description
The Per-protocol (PP) population included all subjects who treated at least one (and up to four) migraine episode(s) with Sumavel DosePro and complied with all other study procedures.
Arm/Group Title Sumavel DosePro
Hide Arm/Group Description:
The primary study endpoint was overall subject satisfaction with Sumavel DosePro, based on a comparison of the subject’s self-reported answer to the single overall satisfaction question completed at the beginning of the study based on his or her pre-study triptan treatment versus at the end of their treatment period.
Overall Number of Participants Analyzed 211
Mean (Standard Deviation)
Unit of Measure: Scale of 0-100; 100= very satisfied
73.7  (29.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sumavel DosePro
Comments For the primary analyses and other PPMQ-R variables, the mean of the differences between each subject’s rating of overall treatment satisfaction at the end of study based on the subject’s experience using Sumavel DosePro and the rating at baseline based on the subject’s pre-study triptan treatment were compared using a two-sided paired t-test at the 5% level of significance
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0007
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Treatment Preference
Hide Description Number of subjects preferring Sumavel DosePro compared to their pre-study migraine treatment (Prefer Sumavel DosePro vs. No Preference or Prefer Other Treatment).
Time Frame After 4 migraines or 60 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sumavel DosePro
Hide Arm/Group Description:
The primary study endpoint was overall subject satisfaction with Sumavel DosePro, based on a comparison of the subject’s self-reported answer to the single overall satisfaction question completed at the beginning of the study based on his or her pre-study triptan treatment versus at the end of their treatment period.
Overall Number of Participants Analyzed 211
Measure Type: Number
Unit of Measure: participants
74
3.Secondary Outcome
Title Treatment Confidence
Hide Description Number of subjects who indicated they were confident or very confident in treating repeated migraine attacks with Sumavel DosePro at end of treatment.
Time Frame After 4 migraines or 60 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sumavel DosePro
Hide Arm/Group Description:
The primary study endpoint was overall subject satisfaction with Sumavel DosePro, based on a comparison of the subject’s self-reported answer to the single overall satisfaction question completed at the beginning of the study based on his or her pre-study triptan treatment versus at the end of their treatment period.
Overall Number of Participants Analyzed 211
Measure Type: Number
Unit of Measure: participants
136
Time Frame 60 days
Adverse Event Reporting Description Subjects were asked to report SAEs from first dose of Sumavel DosePro up to 3-5 days post 4th migraine attack or 60 days, which ever occurred earliest.
 
Arm/Group Title Sumavel DosePro
Hide Arm/Group Description The primary study endpoint was overall subject satisfaction with Sumavel DosePro, based on a comparison of the subject’s self-reported answer to the single overall satisfaction question completed at the beginning of the study based on his or her pre-study triptan treatment versus at the end of their treatment period.
All-Cause Mortality
Sumavel DosePro
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sumavel DosePro
Affected / at Risk (%)
Total   0/242 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sumavel DosePro
Affected / at Risk (%)
Total   136/242 (56.20%) 
Gastrointestinal disorders   
Nausea * 1  18/242 (7.44%) 
Dry mouth * 1  12/242 (4.96%) 
General disorders   
Administrative site conditions * 1 [1]  99/242 (40.91%) 
Musculoskeletal and connective tissue disorders   
Muscle tightness * 1  14/242 (5.79%) 
Nervous system disorders   
Dizzyness * 1  17/242 (7.02%) 
Paresthesia * 1  14/242 (5.79%) 
Somnolence * 1  13/242 (5.37%) 
Vascular disorders   
Flushing * 1  14/242 (5.79%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
[1]
Inclusive of all single reports of injection site hemorrhage,hematoma, pain, swelling, and erythema
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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
Name/Title: Judith Myers, Senior Director Clinical Operations
Organization: Zogenix
Phone: 510-550-8300
Responsible Party: Zogenix, Inc.
ClinicalTrials.gov Identifier: NCT01016834     History of Changes
Other Study ID Numbers: ZX001-0901
First Submitted: November 18, 2009
First Posted: November 20, 2009
Results First Submitted: November 28, 2011
Results First Posted: December 29, 2011
Last Update Posted: December 29, 2011