"Completeness of Response" Following Treatment With Treximet™ for Migraine - Study Results

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Migraine
Intervention:	Drug: sumatriptan succinate 85 mg/naproxen sodium 500 mg (Treximet)

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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

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

Reporting Groups

	Description
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.

Participant Flow: Overall Study

	Treximet
STARTED	147
COMPLETED	135
NOT COMPLETED	12
Adverse Event	4
Withdrawal by Subject	2
Lost to Follow-up	6

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
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.

Baseline Measures

	Treximet
Number of Participants [units: participants]	147
Age [units: participants]
<=18 years	0
Between 18 and 65 years	145
>=65 years	2
Age [units: years] Mean ± Standard Deviation	44.3 ± 11.0
Gender [units: participants]
Female	128
Male	19
Region of Enrollment [units: participants]
United States	147

Outcome Measures

Hide All Outcome Measures

1. Primary:

Change in Scores From Completeness of Response Survey (CORS) [ Time Frame: Visit 1 (screening) and Visit 2 (study completion following 2-month treatment period) ]

Measure Type	Primary
Measure Title	Change in Scores From Completeness of Response Survey (CORS)
Measure 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)
Safety Issue	No

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
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.

Measured Values

	Treximet
Number of Participants Analyzed [units: participants]	147
Change in Scores From Completeness of Response Survey (CORS) [units: Units on a scale] Mean ( 95% Confidence Interval )
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 )

No statistical analysis provided for Change in Scores From Completeness of Response Survey (CORS)

2. Secondary:

Percent of Participants Reporting Treximet Provides Therapeutic Advantage Over Usual Pre-study Triptan [ Time Frame: Visit 1 (screening) and Visit 2 (study completion following 2-month treatment period) ]

Measure Type	Secondary
Measure Title	Percent of Participants Reporting Treximet Provides Therapeutic Advantage Over Usual Pre-study Triptan
Measure 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)
Safety Issue	No

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
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.

Measured Values

	Treximet
Number of Participants Analyzed [units: participants]	147
Percent of Participants Reporting Treximet Provides Therapeutic Advantage Over Usual Pre-study Triptan [units: 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

No statistical analysis provided for Percent of Participants Reporting Treximet Provides Therapeutic Advantage Over Usual Pre-study Triptan

3. Secondary:

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) [ Time Frame: Visit 1 (screening) and Visit 2 (study completion following 2-month treatment period) ]

Measure Type	Secondary
Measure 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)
Measure 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)
Safety Issue	No

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
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.

Measured Values

	Treximet
Number of Participants Analyzed [units: participants]	147
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) [units: Units on a scale] Mean ( 95% Confidence Interval )
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 )

No statistical analysis provided for 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)

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

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.

Results Point of Contact:

Name/Title: Rebecca Browning
Organization: Clinvest
phone: (417) 841-3664
e-mail: rbrowning@clinvest.com

Publications:

Smith TR, Sunshine A, Stark SR, Littlefield DE, Spruill SE, Alexander WJ. Sumatriptan and naproxen sodium for the acute treatment of migraine. Headache. 2005 Sep;45(8):983-91.

Brandes JL, Kudrow D, Stark SR, O'Carroll CP, Adelman JU, O'Donnell FJ, Alexander WJ, Spruill SE, Barrett PS, Lener SE. Sumatriptan-naproxen for acute treatment of migraine: a randomized trial. JAMA. 2007 Apr 4;297(13):1443-54.

Silberstein SD. Practice parameter: evidence-based guidelines for migraine headache (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2000 Sep 26;55(6):754-62. No abstract available. Erratum in: Neurology 2000 Jan 9;56(1):142.

Responsible Party:	Roger K. Cady, MD, Clinvest
ClinicalTrials.gov Identifier:	NCT00893737 History of Changes
Other Study ID Numbers:	110211
Study First Received:	May 5, 2009
Results First Received:	September 22, 2010
Last Updated:	January 4, 2011
Health Authority:	United States: Institutional Review Board