Phase 3
Completed N=375
TREXIMET® Versus Butalbital-containing Combination Medications for the Acute Treatment of Migraine in Adults
Migraine Disorders · Migraine, Acute
Source: ClinicalTrials.gov NCT00573170 ↗
Enrolled (actual)
375
Serious AEs
0.3%
Results posted
Dec 2010
Primary outcomePrimary: Number of Participants With a Sustained Pain-free (SPF) Response From 2 to 24 Hours Post-dose — 10; 26; 18 participants — p=0.378
Summary
Study TRX109011/TRX109013, A Randomized, Double-blind, Double-dummy, Placebo-controlled, Crossover Study to Evaluate the Efficacy of TREXIMET® (Sumatriptan + Naproxen Sodium) versus Butalbital-containing Combination Medications (BCM) for the Acute Treatment of Migraine when administered during the Moderate-Severe Pain Phase of the Migraine (Studies 1 and 2 of 2)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Sustained Pain-free (SPF) Response From 2 to 24 Hours Post-dose |
10; 26; 18 | 0.378 |
| SECONDARY Number of Participants With a Pain-free Response From 2 to 48 Hours Post-dose |
16; 45; 26; 21; 86; 39 | — |
| SECONDARY Number of Participants Using Rescue Medication Within 48 Hours Post Dose |
25; 19; 25; 234; 158; 203 | — |
| SECONDARY Mean Time to First Use of Rescue Medication for the First Attack Treated With Study Medication (Attack 1) |
12.00; 17.07; 20.15 | — |
| SECONDARY Mean Time to First Use of Rescue Medication for the Second Attack Treated With Study Medication (Attack 2) |
8.29; 20.90; 16.70 | — |
| SECONDARY Mean Time to First Use of Rescue Medication for the Third Attack Treated With Study Medication (Attack 3) |
6.69; 20.77; 9.44 | — |
| SECONDARY Number of Participants With a Migraine-free Response 2-48 Hours After Dosing |
14; 33; 22; 20; 74; 37 | — |
| SECONDARY Number of Participants With Pain-freedom and Relief of Nausea at 2, 4, 6, 8, 24 and 48 Post-dose Time Points |
5; 13; 8; 6; 28; 8 | — |
| SECONDARY Number of Participants With Pain-freedom and Relief of Photophobia at 2, 4, 6, 8, 24 and 48 Post-dose Time Points |
11; 30; 16; 16; 64; 23 | — |
| SECONDARY Number of Participants With Pain-freedom and Relief of Phonophobia at 2, 4, 6, 8, 24 and 48 Post-dose Time Points |
11; 25; 15; 15; 57; 24 | — |
| SECONDARY Number of Participants With Pain-freedom and Relief of Vomiting at 2, 4, 6, 8, 24 and 48 Hours Post-dose |
1; 0; 0; 1; 1; 0 | — |
| SECONDARY Number of Participants With Relief From Sinus/Facial Pain at 2, 4, 6, 8, 24 and 48 Hours After Dosing in Those Who Also Had the Symptom at Dosing |
5; 14; 9; 4; 35; 17 | — |
| SECONDARY Number of Participants With Relief From Neck Pain at 2, 4, 6, 8, 24 and 48 Hours After Dosing Who Also Had the Symptom at Baseline |
4; 19; 14; 7; 43; 22 | — |
| SECONDARY Number of Participants With Pain Relief at 2, 4, 6, 8, 24 and 48 Hours After Dosing Moderate or Severe Baseline Pain |
76; 148; 114; 51; 124; 90 | — |
| SECONDARY Number of Participants Who Reported a Complete Symptom-Free Response at 2, 4, 6, 8, 24 and 48 Hours After Dosing |
13; 29; 21; 19; 68; 36 | — |
| SECONDARY Mean Performance Index (PI) Scores at Time of Dosing and at 2, 4, 6, 8, 24 and 48 Hours After Dosing |
7.36; 7.29; 7.30; 7.33; 7.37; 7.27 | — |
| SECONDARY Mean Stanford Sleepiness (SS) Scale Scores at Time of Dosing and at 2, 4, 6, 8, 24 and 48 Hours After Dosing |
3.94; 3.97; 4.00; 3.88; 3.87; 3.88 | — |
| SECONDARY Efficacy Subscore as Measured by the Revised Patient Perception of Migraine (PPMQ-R) Questionnaire 24 Hours After Treating a Migraine |
55; 62; 56 | — |
| SECONDARY Functionality Subscore as Measured by the Revised Patient Perception of Migraine (PPMQ-R) Questionnaire 24 Hours After Taking Study Medication |
55; 61; 56 | — |
| SECONDARY Ease-of-Use Subscore as Measured by the Revised Patient Perception of Migraine (PPMQ-R) Questionnaire 24 Hours After Taking Study Medication |
79; 82; 78 | — |
| SECONDARY Bothersomeness-of-side Effect Subscore as Measured by the Revised Patient Perception of Migraine (PPMQ-R) Questionnaire 24 Hours After Taking Study Medication |
88; 86; 89 | — |
| SECONDARY Total PPMQ-R Score as Measured With the Revised Patient Perception of Migraine (PPMQ-R) Questionnaire 24 Hours After Taking Study Medication |
63; 68; 63 | — |
| SECONDARY Numbers of Participants Able to "Engage in Normal Activities Not Impaired" at Time of Dosing and 2, 4, 6, and 8 Hours After Dosing as Assessed by the CDQ (Clinical Disability Questionnaire) |
9; 8; 10; 19; 33; 29 | — |
Eligibility Criteria
Inclusion Criteria
- Males and females aged 18 to 65 years. Female subjects are eligible for participation if they are either of non-childbearing potential (not capable of becoming pregnant) OR of childbearing potential having a negative urine pregnancy test at screening, and using contraception if sexually active. If using oral contraceptives, the subjects should be on a stable regimen of oral contraceptives (>/= 2 months).
Eligible subjects must:
- have migraine with or without aura (2004 ICHD-II criteria) and must have had at least 2 attacks per month meeting these criteria in the three months prior to screening.
- have documented use of Butalbital-containing Combination Medication (MCM) to have treated at least one migraine.
- be able to understand how to complete the cognitive assessments and all other questionnaires programmed in an electronic diary.
- be willing and able to provide written informed consent.
Exclusion Criteria
A subject is not eligible if they have:
- >8 migraines or >/= 15 headache days per month in total, or has retinal, basilar, or hemiplegic migraine, or secondary headaches.
- taken >350mg/day of butalbital and/or other barbiturates on an equivalent dose basis, on average, over the 30 days prior to screening.
- is likely to have unrecognized cardiovascular or cerebrovascular disease (based on history or risk factors).
- blood pressure >/= 140/90mmHg in 2 out of 3 BP measurements or is taking any angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker.
- history of congenital heart disease, cardiac arrhythmias requiring medication, or a clinical significant electrocardiogram abnormality.
- evidence or history of any ischemic vascular disease including: ischemic heart disease, ischemic abdominal syndromes, peripheral vascular disease or Raynaud's Syndrome, or signs/symptoms consistent with these.
- evidence or history of central nervous system pathology including stroke and/or transient ischemic attacks (TIAs), epilepsy or structural brain lesions which lower the convulsive threshold; or has been treated with an antiepileptic drug for seizure control within 5 years prior to screening.
- a history of impaired hepatic or renal function that contraindicates participation in the study.
- hypersensitivity, allergy, intolerance, or contraindication to the use of any triptan, NSAID, aspirin, barbiturates, or acetaminophen (including all sumatriptan and naproxen preparations), has porphyria or has nasal polyps and asthma.
- is currently taking, or has taken in the previous three months, an ergot preparation for migraine prophylaxis; or is taking a migraine or prophylactic medication that is not stabilized (i.e. a change of dose within the last 2 months) for either chronic or intermittent migraine prophylaxis or for a co-morbid condition that is not stabilized.
- a recent history of regular use of opioids (including opioids in combination with butalbital, e.g. Fioricet with codeine) or barbiturates other than butalbital. Regular use is defined as an average of 4 days per month over the last 6 months.
- taken, or plans to take, a monoamine oxidase inhibitor (MAOI), including herbal preparations containing St. John's Wort (Hypericum perforatum), anytime within the 2 weeks prior to screening through 2 weeks post final study treatment.
- history of any bleeding disorder or is currently taking any anti-coagulant or any antiplatelet agent (except low-dose aspirin </= 325mg/day for cardioprotective reasons).
- evidence or history of any gastrointestinal surgery or GI ulceration or perforation in the past six months, gastrointestinal bleeding in the past year; or evidence or history of inflammatory bowel disease.
- is pregnant, actively trying to become pregnant, breast feeding, or not willing to have pregnancy test performed.
- evidence of alcohol or substance abuse within the last year or any concurrent medical or psychiatric condition which, in the investigator's judgement, will likely
Data sourced from ClinicalTrials.gov (NCT00573170). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.