Trial Outcomes & Findings for TREXIMET (Formerly Known as TREXIMA) for the Acute Treatment of Probable Migraine (ICHD-II 1.6.1) (NCT NCT00387881)

NCT ID: NCT00387881

Last Updated: 2016-12-16

Results Overview

Pain-free was defined as a headache severity of no pain (grade 0) at 2 hours post-treatment in subjects who have not used rescue medication prior to or at the time of the assessment. Sustained pain-free response was defined as pain-free at 2 hours post-treatment through 24 hours post-treatment without rescue medicine.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 679 participants
• Primary outcome timeframe: 2 hours through 24 hours after Treatment
• Results posted on: 2016-12-16

Participant Flow

Participant milestones

Measure	Placebo	Sumatriptan/Naproxen Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
Overall Study STARTED	334	345
Overall Study COMPLETED	245	243
Overall Study NOT COMPLETED	89	102

Reasons for withdrawal

Measure	Placebo	Sumatriptan/Naproxen Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
Overall Study Lost to Follow-up	23	23
Overall Study Protocol Violation	2	12
Overall Study Withdrawal by Subject	15	18
Overall Study Sponsor terminated Study	0	1
Overall Study Not eligible	6	7
Overall Study No opportunity to treat headache	32	34
Overall Study Not otherwise specified	11	7

Baseline Characteristics

TREXIMET (Formerly Known as TREXIMA) for the Acute Treatment of Probable Migraine (ICHD-II 1.6.1)

Baseline characteristics by cohort

Measure	Placebo n=246 Participants Baseline Characteristics used the Safety Population. Not the Randomised Population	Sumatriptan/Naproxen n=254 Participants Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet. Baseline Characteristics used the Safety Population. Not the Randomised Population	Total n=500 Participants Total of all reporting groups
Age, Continuous	36.6 years STANDARD_DEVIATION 11.23 • n=5 Participants	35.8 years STANDARD_DEVIATION 11.47 • n=7 Participants	36.2 years STANDARD_DEVIATION 11.35 • n=5 Participants
Gender Female	176 Participants n=5 Participants	195 Participants n=7 Participants	371 Participants n=5 Participants
Gender Male	70 Participants n=5 Participants	59 Participants n=7 Participants	129 Participants n=5 Participants
Race/Ethnicity, Customized African American/African Heritage	28 Participants n=5 Participants	30 Participants n=7 Participants	58 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian - East Asian Heritage	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Race/Ethnicity, Customized Asian - Japanese Heritage	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Asian - South East Asian Heritage	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White - Arabic/North African Heritage	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized White - White/Caucasian/European Heritage	199 Participants n=5 Participants	206 Participants n=7 Participants	405 Participants n=5 Participants
Race/Ethnicity, Customized Mixed race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Missing	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 hours through 24 hours after Treatment

Population: The Intent to Treat (ITT) Population was the primary analysis population for assessing efficacy and included subjects who treated at least 1 headache attack with randomized treatment and provided at least one post dose evaluation.

Pain-free was defined as a headache severity of no pain (grade 0) at 2 hours post-treatment in subjects who have not used rescue medication prior to or at the time of the assessment. Sustained pain-free response was defined as pain-free at 2 hours post-treatment through 24 hours post-treatment without rescue medicine.

Outcome measures

Measure	Placebo n=221 Participants	Sumatriptan/Naproxen n=222 Participants Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
Pain-Free at 2 Hours Post-dose and Sustained Pain-Free From 2-24 Hours Post-dose. Pain-Free (2 hours)	25 Participants	64 Participants
Pain-Free at 2 Hours Post-dose and Sustained Pain-Free From 2-24 Hours Post-dose. Sustained Pain-Free (2-24 hours)	20 Participants	54 Participants

SECONDARY outcome

Timeframe: 0.5, 1, and 4 hours after Treatment

Population: ITT Population

Pain-Free is defined as post-treatment headache pain severity of none in subjects who have not used rescue medication prior to or at the time of the assessment.

Outcome measures

Measure	Placebo n=221 Participants	Sumatriptan/Naproxen n=222 Participants Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
Freedom From Headache Pain at 0.5, 1, and 4 Hours After Treatment Pain-free at 4 hours	60 Participants	105 Participants
Freedom From Headache Pain at 0.5, 1, and 4 Hours After Treatment Pain-free at 1 hour	16 Participants	23 Participants
Freedom From Headache Pain at 0.5, 1, and 4 Hours After Treatment Pain-free at 0.5 hour	6 Participants	5 Participants

SECONDARY outcome

Timeframe: 2-24 hours after treatment

Population: ITT Population

Sustained pain relief was defined as having pain relief (mild or no pain) at 2 hours w/o any moderate or severe pain during 2-24 hour period post-treatment, without rescue medication.

Outcome measures

Measure	Placebo n=221 Participants	Sumatriptan/Naproxen n=222 Participants Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
Sustained Headache Relief 2-24 Hours After Treatment	77 Participants	110 Participants

SECONDARY outcome

Timeframe: 0.5, 1, 2, and 4 hours after treatment

Population: ITT Population

Pain relief was defined as reduction of headache pain from a baseline severity of moderate or severe to none or mild at the given time.

Outcome measures

Measure	Placebo n=221 Participants	Sumatriptan/Naproxen n=222 Participants Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
Headache Relief at 4, 2, 1 and 0.5 Hours After Treatment Headache relief at 4 hours	108 Participants	153 Participants
Headache Relief at 4, 2, 1 and 0.5 Hours After Treatment Headache relief at 2 hours	113 Participants	124 Participants
Headache Relief at 4, 2, 1 and 0.5 Hours After Treatment Headache relief at 1 hour	73 Participants	85 Participants
Headache Relief at 4, 2, 1 and 0.5 Hours After Treatment Headache relief at 0.5 hour	39 Participants	41 Participants

SECONDARY outcome

Timeframe: 0 - 24 hours after treatment

Population: ITT Population

Rescue medication defined as additional medication (i.e. sumatriptan/naproxen sodium as open-label rescue or other medication as permitted per protocol), taken by subject for the treatment of headache pain or other symptoms associated with the headache attack.

Outcome measures

Measure	Placebo n=221 Participants	Sumatriptan/Naproxen n=222 Participants Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
Subjects Who Used Rescue Medication From 0 - 24 Hours After Treatment	101 Participants	61 Participants

SECONDARY outcome

Timeframe: 1-2, and 2- 4 hours after treatment

Population: ITT Population

Intermediate sustained pain relief was defined as achieving headache pain relief (from moderate or severe pain at baseline to mild or no pain) prior to the specified timepoint (1 or 2 hours) and maintaining it to the specified timepoint (2-4 hours). (Intermediate=Intermed.)

Outcome measures

Measure	Placebo n=221 Participants	Sumatriptan/Naproxen n=222 Participants Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
Intermediate Sustained Pain Relief: Post-dose at Intervals of 2-4 Hours and 1-2 Hours After Treatment Intermed. Sustained Pain Relief, 2-4 hrs post-dose	92 Participants	118 Participants
Intermediate Sustained Pain Relief: Post-dose at Intervals of 2-4 Hours and 1-2 Hours After Treatment Intermed. Sustained Pain Relief, 1-2 hrs post-dose	67 Participants	84 Participants

SECONDARY outcome

Timeframe: 1-2 and 2-4 hours after treatment

Population: ITT Population

Intermediate sustained pain free was defined as achieving headache pain-free (moderate or severe pain to no pain) prior to the specified timepoint (1 or 2 hours) and maintaining it to the specified timepoint (2-4 hours).(Intermediate=Intermed.)

Outcome measures

Measure	Placebo n=221 Participants	Sumatriptan/Naproxen n=222 Participants Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
Intermediate Sustained Pain-Free: Post-dose at Intervals of 2-4 Hours and 1-2 Hours Intermed. Sustained Pain-free, 2-4 hrs post-dose	22 Participants	61 Participants
Intermediate Sustained Pain-Free: Post-dose at Intervals of 2-4 Hours and 1-2 Hours Intermed. Sustained Pain-free, 1-2 hrs post-dose	11 Participants	23 Participants

SECONDARY outcome

Timeframe: 2 and 4 hours after treatment

Population: ITT Population

Neck pain, sinus pain, photophobia, phonophobia and nausea are considered headache-associated symptoms.(Headache-associated=Headache-Assoc.)

Outcome measures

Measure	Placebo n=221 Participants	Sumatriptan/Naproxen n=222 Participants Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
Incidence of Headache Associated: Neck Pain, Sinus Pain, Photophobia, Phonophobia, Nausea at Time Intervals of 4 and 2 Hours After Treatment Headache-Assoc. Photophobia at 4 hours	87 Participants	60 Participants
Incidence of Headache Associated: Neck Pain, Sinus Pain, Photophobia, Phonophobia, Nausea at Time Intervals of 4 and 2 Hours After Treatment Headache-Assoc. Neck Pain at 4 hours	93 Participants	63 Participants
Incidence of Headache Associated: Neck Pain, Sinus Pain, Photophobia, Phonophobia, Nausea at Time Intervals of 4 and 2 Hours After Treatment Headache-Assoc. Neck Pain at 2 hours	68 Participants	59 Participants
Incidence of Headache Associated: Neck Pain, Sinus Pain, Photophobia, Phonophobia, Nausea at Time Intervals of 4 and 2 Hours After Treatment Headache-Assoc. Sinus Pain at 4 hours	88 Participants	49 Participants
Incidence of Headache Associated: Neck Pain, Sinus Pain, Photophobia, Phonophobia, Nausea at Time Intervals of 4 and 2 Hours After Treatment Headache-Assoc. Sinus Pain at 2 hours	49 Participants	36 Participants
Incidence of Headache Associated: Neck Pain, Sinus Pain, Photophobia, Phonophobia, Nausea at Time Intervals of 4 and 2 Hours After Treatment Headache-Assoc. Photophobia at 2 hours	60 Participants	46 Participants
Incidence of Headache Associated: Neck Pain, Sinus Pain, Photophobia, Phonophobia, Nausea at Time Intervals of 4 and 2 Hours After Treatment Headache-Assoc. Phonophobia at 4 hours	83 Participants	59 Participants
Incidence of Headache Associated: Neck Pain, Sinus Pain, Photophobia, Phonophobia, Nausea at Time Intervals of 4 and 2 Hours After Treatment Headache-Assoc. Phonophobia at 2 hours	53 Participants	54 Participants
Incidence of Headache Associated: Neck Pain, Sinus Pain, Photophobia, Phonophobia, Nausea at Time Intervals of 4 and 2 Hours After Treatment Headache-Assoc. Nausea at 4 hours	82 Participants	51 Participants
Incidence of Headache Associated: Neck Pain, Sinus Pain, Photophobia, Phonophobia, Nausea at Time Intervals of 4 and 2 Hours After Treatment Headache-Assoc. Nausea at 2 hours	37 Participants	36 Participants

SECONDARY outcome

Timeframe: 0 - 24 hours after treatment

Population: ITT Population - Actual numbers of subjects who took questionnaire were Placebo 199 and Sumatriptan/Naproxen=188

Patient Perception of Migraine Questionnaire-Revised(PPMQ-R) evaluates subject satisfaction with treatment 24 hours post-dose using validated questions. Questions are analyzed on 4 subscale scores (efficacy, functionality, ease-of-use, and tolerability) and total score. Scores range from 0-100, with the higher scores indicating better satisfaction.

Outcome measures

Measure	Placebo n=199 Participants	Sumatriptan/Naproxen n=188 Participants Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
Medication Satisfaction: Mean Patient Perception of Migraine (PPMQ-R) Subscale Score Efficacy Adjusted Mean	53 Score in scale Standard Error 2.0	67 Score in scale Standard Error 2.0
Medication Satisfaction: Mean Patient Perception of Migraine (PPMQ-R) Subscale Score Functionality Adjusted Mean	56 Score in scale Standard Error 2.1	70 Score in scale Standard Error 2.1
Medication Satisfaction: Mean Patient Perception of Migraine (PPMQ-R) Subscale Score Ease-of-Use Adjusted Mean	84 Score in scale Standard Error 1.3	88 Score in scale Standard Error 1.3
Medication Satisfaction: Mean Patient Perception of Migraine (PPMQ-R) Subscale Score Bothersome-of-Side Effects Adjusted Mean	94 Score in scale Standard Error 0.8	91 Score in scale Standard Error 0.8
Medication Satisfaction: Mean Patient Perception of Migraine (PPMQ-R) Subscale Score Total Score adjusted Mean	64 Score in scale Standard Error 1.5	75 Score in scale Standard Error 1.6

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sumatriptan/Naproxen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

• Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the Publication of results from all centers of a multi-center trial but requests that reports based on Single-site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER