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"Completeness of Response" Following Treatment With Treximet™ for Migraine

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ClinicalTrials.gov Identifier: NCT00893737
Recruitment Status : Completed
First Posted : May 6, 2009
Results First Posted : January 25, 2011
Last Update Posted : January 25, 2011
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Cady, Roger, M.D.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Migraine
Intervention Drug: sumatriptan succinate 85 mg/naproxen sodium 500 mg (Treximet)
Enrollment 147
Recruitment Details First Patient In 6/2/09 Last Patient In 7/17/09 Patients enrolled at 5 Headache Specialty clinics, 2 Primary Care practices, and 1 Neurological practice.
Pre-assignment Details  
Arm/Group Title Treximet
Hide Arm/Group Description Treximet (a combination of sumatriptan 85 mg and naproxen sodium 500 mg) 1 tablet to be administered as soon as patient has headache indicative of migraine. Patient may treat up to 16 migraine attacks in 2 month study period.
Period Title: Overall Study
Started 147
Completed 135
Not Completed 12
Reason Not Completed
Adverse Event             4
Withdrawal by Subject             2
Lost to Follow-up             6
Arm/Group Title Treximet
Hide Arm/Group Description Treximet (a combination of sumatriptan 85 mg and naproxen sodium 500 mg) 1 tablet to be administered as soon as patient has headache indicative of migraine. Patient may treat up to 16 migraine attacks in 2 month study period.
Overall Number of Baseline Participants 147
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 147 participants
<=18 years
0
   0.0%
Between 18 and 65 years
145
  98.6%
>=65 years
2
   1.4%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 147 participants
44.3  (11.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 147 participants
Female
128
  87.1%
Male
19
  12.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 147 participants
147
1.Primary Outcome
Title Change in Scores From Completeness of Response Survey (CORS)
Hide Description

CORS scores for Pain (0-4), Associated Symptoms (0-4), Limbic/Affective Symptoms (0-5), and Speed of Return to Functionality (1-5), represent outcome measures that are relevant to patients. Higher scores represent better treatment efficacy.

The analysis compares CORS scores for usual triptan (pre-study) versus (vs.) Treximet (study medication).

Time Frame Visit 1 (screening) and Visit 2 (study completion following 2-month treatment period)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treximet
Hide Arm/Group Description:
Treximet (a combination of sumatriptan 85 mg and naproxen sodium 500 mg) 1 tablet to be administered as soon as patient has headache indicative of migraine. Patient may treat up to 16 migraine attacks in 2 month study period.
Overall Number of Participants Analyzed 147
Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
Pain Score
0.17
(0.03 to 0.30)
Associated Symptoms Score
0.07
(-0.09 to 0.24)
Limbic Symptoms Score
0.03
(-0.12 to 0.18)
Functionality Score
0.10
(-0.05 to 0.26)
2.Secondary Outcome
Title Percent of Participants Reporting Treximet Provides Therapeutic Advantage Over Usual Pre-study Triptan
Hide Description CORS completed at Visit 1 regarding participant pre-study triptan and at Visit 2 regarding Treximet taken in study. Areas of therapeutic advantage evaluated: How often does 1 dose completely relieve (1) headache pain (2) neck/shoulder pain (3) nausea (4) light sensitivity (5) sound sensitivity (6) irritability. How quickly can/do you (1) concentrate or think clearly (2) resume normal activities (3) function normally (4) feel completely normal. How confident are you that (1) one dose will completely relieve migraine within 2 hours (2) once relieved, migraine will not return within 24 hours.
Time Frame Visit 1 (screening) and Visit 2 (study completion following 2-month treatment period)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treximet
Hide Arm/Group Description:
Treximet (a combination of sumatriptan 85 mg and naproxen sodium 500 mg) 1 tablet to be administered as soon as patient has headache indicative of migraine. Patient may treat up to 16 migraine attacks in 2 month study period.
Overall Number of Participants Analyzed 147
Measure Type: Number
Unit of Measure: Percent of Participants
How often 1 dose relieves headache pain 42
How often 1 dose relieves neck/shoulder pain 52
How often 1 dose relieves nausea 43
How often 1 dose relieves light sensitivity 42
How often 1 dose relieves sound sensitivity 45
How often 1 dose relieves irritability 36
How quickly can you concentrate or think clearly 31
How quickly can you resume normal activities 32
How quickly can you function normally 32
How quickly do you feel completely normal 36
Confidence 1 dose will relieve migraine in 2 hours 33
Confidence migraine will not return in 24 hours 38
3.Secondary Outcome
Title Paired T-test Indicating Greater Subject Satisfaction With Treximet Over Usual Pre-study Triptan as Determined by the Revised Patient Perception of Migraine Questionnaire (PPMQ-R)
Hide Description Scores calculated for (1) Efficacy (2) Functionality (3) Ease of use (4) Cost. Higher score represents better treatment satisfaction.
Time Frame Visit 1 (screening) and Visit 2 (study completion following 2-month treatment period)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treximet
Hide Arm/Group Description:
Treximet (a combination of sumatriptan 85 mg and naproxen sodium 500 mg) 1 tablet to be administered as soon as patient has headache indicative of migraine. Patient may treat up to 16 migraine attacks in 2 month study period.
Overall Number of Participants Analyzed 147
Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
Efficacy
8.61
(4.64 to 12.58)
Functionality
13.86
(9.39 to 18.32)
Ease of Use
2.76
(-0.11 to 5.64)
Cost
7.28
(1.83 to 12.72)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treximet
Hide Arm/Group Description Treximet (a combination of sumatriptan 85 mg and naproxen sodium 500 mg) 1 tablet to be administered as soon as patient has headache indicative of migraine. Patient may treat up to 16 migraine attacks in 2 month study period.
All-Cause Mortality
Treximet
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treximet
Affected / at Risk (%) # Events
Total   2/147 (1.36%)    
Nervous system disorders   
Migraine without aura  1 [1]  1/147 (0.68%)  1
Respiratory, thoracic and mediastinal disorders   
Pneumonia  1  1/147 (0.68%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, Verbatim Response
[1]
without intractable headache, but with Status Migrainosus
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Treximet
Affected / at Risk (%) # Events
Total   28/147 (19.05%)    
Gastrointestinal disorders   
Nausea  1  9/147 (6.12%)  20
General disorders   
Chest Tightness  1  4/147 (2.72%)  8
Jittery  1  3/147 (2.04%)  19
Nervous system disorders   
Dizziness  1  5/147 (3.40%)  9
Light Headed  1  4/147 (2.72%)  6
Sleepy  1  5/147 (3.40%)  21
Tired  1  4/147 (2.72%)  14
Indicates events were collected by systematic assessment
1
Term from vocabulary, Verbatim Response
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.
Publication of Results is specifically authorized, subject to the provisions of STUDY AGREEMENT. INVESTIGATOR is free to publish Results of its part of study in collaboration with other investigators, but in compliance with confidentiality agreement and subsequent to full study publication issued by CLINVEST. INVESTIGATOR agrees to submit a copy of any results communication to CLINVEST for review and comment 60 days prior to submission for publication.
Results Point of Contact
Name/Title: Rebecca Browning
Organization: Clinvest
Phone: (417) 841-3664
Responsible Party: Roger K. Cady, MD, Clinvest
ClinicalTrials.gov Identifier: NCT00893737     History of Changes
Other Study ID Numbers: 110211
First Submitted: May 5, 2009
First Posted: May 6, 2009
Results First Submitted: September 22, 2010
Results First Posted: January 25, 2011
Last Update Posted: January 25, 2011