Trial Outcomes & Findings for "Completeness of Response" Following Treatment With Treximet™ for Migraine (NCT NCT00893737)
NCT ID: NCT00893737
Last Updated: 2011-01-25
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
147 participants
Primary outcome timeframe
Visit 1 (screening) and Visit 2 (study completion following 2-month treatment period)
Results posted on
2011-01-25
Participant Flow
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.
Participant milestones
| Measure |
Treximet
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 Study
STARTED
|
147
|
|
Overall Study
COMPLETED
|
135
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
Treximet
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 Study
Adverse Event
|
4
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Lost to Follow-up
|
6
|
Baseline Characteristics
"Completeness of Response" Following Treatment With Treximet™ for Migraine
Baseline characteristics by cohort
| Measure |
Treximet
n=147 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
145 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
|
Age Continuous
|
44.3 years
STANDARD_DEVIATION 11.0 • n=99 Participants
|
|
Sex: Female, Male
Female
|
128 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
147 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Visit 1 (screening) and Visit 2 (study completion following 2-month treatment period)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).
Outcome measures
| Measure |
Treximet
n=147 Participants
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.
|
|---|---|
|
Change in Scores From Completeness of Response Survey (CORS)
Pain Score
|
0.17 Units on a scale
Interval 0.03 to 0.3
|
|
Change in Scores From Completeness of Response Survey (CORS)
Associated Symptoms Score
|
0.07 Units on a scale
Interval -0.09 to 0.24
|
|
Change in Scores From Completeness of Response Survey (CORS)
Limbic Symptoms Score
|
0.03 Units on a scale
Interval -0.12 to 0.18
|
|
Change in Scores From Completeness of Response Survey (CORS)
Functionality Score
|
0.10 Units on a scale
Interval -0.05 to 0.26
|
SECONDARY outcome
Timeframe: Visit 1 (screening) and Visit 2 (study completion following 2-month treatment period)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.
Outcome measures
| Measure |
Treximet
n=147 Participants
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.
|
|---|---|
|
Percent of Participants Reporting Treximet Provides Therapeutic Advantage Over Usual Pre-study Triptan
How often 1 dose relieves headache pain
|
42 Percent of Participants
|
|
Percent of Participants Reporting Treximet Provides Therapeutic Advantage Over Usual Pre-study Triptan
How often 1 dose relieves neck/shoulder pain
|
52 Percent of Participants
|
|
Percent of Participants Reporting Treximet Provides Therapeutic Advantage Over Usual Pre-study Triptan
How often 1 dose relieves nausea
|
43 Percent of Participants
|
|
Percent of Participants Reporting Treximet Provides Therapeutic Advantage Over Usual Pre-study Triptan
How often 1 dose relieves light sensitivity
|
42 Percent of Participants
|
|
Percent of Participants Reporting Treximet Provides Therapeutic Advantage Over Usual Pre-study Triptan
How often 1 dose relieves sound sensitivity
|
45 Percent of Participants
|
|
Percent of Participants Reporting Treximet Provides Therapeutic Advantage Over Usual Pre-study Triptan
How often 1 dose relieves irritability
|
36 Percent of Participants
|
|
Percent of Participants Reporting Treximet Provides Therapeutic Advantage Over Usual Pre-study Triptan
How quickly can you concentrate or think clearly
|
31 Percent of Participants
|
|
Percent of Participants Reporting Treximet Provides Therapeutic Advantage Over Usual Pre-study Triptan
How quickly can you resume normal activities
|
32 Percent of Participants
|
|
Percent of Participants Reporting Treximet Provides Therapeutic Advantage Over Usual Pre-study Triptan
How quickly can you function normally
|
32 Percent of Participants
|
|
Percent of Participants Reporting Treximet Provides Therapeutic Advantage Over Usual Pre-study Triptan
How quickly do you feel completely normal
|
36 Percent of Participants
|
|
Percent of Participants Reporting Treximet Provides Therapeutic Advantage Over Usual Pre-study Triptan
Confidence 1 dose will relieve migraine in 2 hours
|
33 Percent of Participants
|
|
Percent of Participants Reporting Treximet Provides Therapeutic Advantage Over Usual Pre-study Triptan
Confidence migraine will not return in 24 hours
|
38 Percent of Participants
|
SECONDARY outcome
Timeframe: Visit 1 (screening) and Visit 2 (study completion following 2-month treatment period)Scores calculated for (1) Efficacy (2) Functionality (3) Ease of use (4) Cost. Higher score represents better treatment satisfaction.
Outcome measures
| Measure |
Treximet
n=147 Participants
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.
|
|---|---|
|
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)
Efficacy
|
8.61 Units on a scale
Interval 4.64 to 12.58
|
|
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)
Functionality
|
13.86 Units on a scale
Interval 9.39 to 18.32
|
|
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)
Ease of Use
|
2.76 Units on a scale
Interval -0.11 to 5.64
|
|
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)
Cost
|
7.28 Units on a scale
Interval 1.83 to 12.72
|
Adverse Events
Treximet
Serious events: 2 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treximet
n=147 participants at risk
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.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.68%
1/147 • Number of events 1
|
|
Nervous system disorders
Migraine without aura
|
0.68%
1/147 • Number of events 1
|
Other adverse events
| Measure |
Treximet
n=147 participants at risk
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.
|
|---|---|
|
General disorders
Chest Tightness
|
2.7%
4/147 • Number of events 8
|
|
Nervous system disorders
Dizziness
|
3.4%
5/147 • Number of events 9
|
|
General disorders
Jittery
|
2.0%
3/147 • Number of events 19
|
|
Nervous system disorders
Light Headed
|
2.7%
4/147 • Number of events 6
|
|
Gastrointestinal disorders
Nausea
|
6.1%
9/147 • Number of events 20
|
|
Nervous system disorders
Sleepy
|
3.4%
5/147 • Number of events 21
|
|
Nervous system disorders
Tired
|
2.7%
4/147 • Number of events 14
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER