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Migraine HeadachesPhase 3NCT00434083

To Evaluate the Safety and Efficacy of Trexima in the Acute Treatment of Migrane Headaches

A Phase 3 study testing sumatriptan and naproxen sodium in people with Migraine Headaches, run by POZEN at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

to demonstrate the superiority of Trexima (combination of sumatriptan as the succinate 85 mg and naproxen sodium 500 mg) versus placebo in the acute treatment of migraine to demonstrate the superiority of Trexima versus the individual components (sumatriptan as the succinate 85 mg and naproxen sodium 500 mg), and to… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Migraine Headaches
What is being tested?
sumatriptan and naproxen sodium
How many people
1,200 participants
Where
2 sitesUnited States
Study dates
Jul 2004to Jan 2005
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • A subject will be eligible for inclusion in this study if all of the following criteria apply:
  • Subject is a male or a female who is not pregnant or is not lactating. A female is eligible to enter and participate in this study if she is of
  • Non-childbearing potential (i.e., physiologically incapable of becoming pregnant): or,
  • Child-bearing potential, has a negative pregnancy test (urine or serum) at screen, and employs one of the following acceptable measures of contraception:
  • Complete abstinence from intercourse from 2 weeks prior to administration of the investigational product, throughout the study, and for a time interval after completion or premature discontinuation from the study to account for elimination of the investigational drug (a minimum of 24 hours); subjects utilizing this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding 2 weeks when they present to the clinic for randomized treatment; or
  • Female sterilization; or
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  • Sterilization of male partner; or implants of levonorgestrel; or
  • Injectable progestogen; or
  • Oral contraceptive (combined or progestogen only); or
  • Any intrauterine device (IUD) with published data showing that the lowest expected failure rate is less than 1% per year (not all IUDs meet this criterion); or
  • Any other method with published data showing that the lowest expected failure rate for that method is less than 1% per year.
  • Barrier method only if used in combination with any of the above.
  • Subject is 18-65 years of age.
  • Subject's first migraine occurred prior to the age of 50 years.
  • Subject has at least a 6-month history of migraine with or without aura according to the International Headache Society criteria (see Appendix I).
  • Subject experienced an average migraine headache frequency of 2-6 moderate or severe attacks per month in the previous 3 months.
  • Subject is able to distinguish his/her migraine attacks as discrete from any other types of headaches.
  • Subject is willing and able to give written informed consent prior to entry into the study.

Who cannot join

  • A subject will not be eligible for this study if any one or more of the following criteria apply:
  • Subject has received another investigational drug within the 4 weeks preceding this study, subject was discontinued from the MT400-303 POZEN study, or subject was enrolled in this study or the MT400-302 POZEN study previously.
  • Subject has any concurrent medical or psychiatric condition that may affect the interpretation of efficacy and/or safety data or which otherwise contraindicates participation in a clinical trial with a new chemical entity. This includes, but is not limited to, chronic unstable debilitating diseases such as HIV infection, multiple sclerosis, cancer, etc.
  • Subject has a clinically significant disorder that, in the opinion of the investigator, would result in the subject's inability to understand and comply with the requirements of the study.
  • Subject has a history, signs, or symptoms of ischemic cardiac, cerebrovascular, or peripheral vascular syndromes or other significant underlying cardiovascular disease.
  • Subject has a history of cardiac arrhythmias requiring medication or a history of a clinically significant electrocardiogram (ECG) abnormality that, in the investigator's opinion, contraindicates participation in this study.
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  • Subject has a history of cerebrovascular pathology including stroke and/or transient ischemic attacks.
  • Subject, in the investigator's opinion, is likely to have unrecognized cardiovascular disease, based on history or the presence of risk factors (e.g., hypertension, hypercholesterolemia, smoker, obesity, diabetes, strong family history of coronary artery disease, female with surgical or physiological menopause, or male over 40 years of age).
  • Subject has evidence or history of ischemic abdominal syndromes, peripheral vascular disease, or Raynaud syndrome.
  • Subject has uncontrolled hypertension at screening (sitting systolic pressure >160 millimeters of mercury [mmHg], diastolic pressure >95 mmHg).
  • Subject has a history of epilepsy or conditions associated with a lowered seizure threshold.
  • Subject has a history of basilar or hemiplegic migraine.
  • Subject has a history of impaired hepatic or renal function that, in the investigator's opinion, contraindicates participation in this study, or the subject has any other abnormal laboratory value of clinical significance for this study.
  • Subject has a history of non-migraine (i.e., tension type, sinus, etc.) headache frequency greater than or equal to 15 days/month in each of the 3 months prior to screening.
  • Subject has had >6 migraine attacks/month in either of the 2 months prior to screening.
  • Subject is currently taking a monoamine oxidase inhibitor (MAOI), has taken an MAOI within the 2 weeks prior to screening, or plans to take an MAOI within 2 weeks after treatment.
  • Subject is currently taking any anti-coagulant (e.g. warfarin) or NSAID (except doses of aspirin ≤ 325 mg per day, used for cardiovascular prophylaxis) on a regular basis.
  • Subject is currently taking or has taken in the previous 3 months, a migraine prophylactic medication containing ergotamine, an ergot derivative (dihydroergotamine), or methysergide.
  • Subject is currently taking or has taken in the previous 4 weeks, herbal preparations containing St. John's Wort (Hypericum perforatum).
  • Subject has hypersensitivity, intolerance, or contraindication to the use of sumatriptan or naproxen sodium, any of its components, or any other 5-HT1 receptor agonist.
  • Subject has history of allergic reactions to naproxen preparations, including subjects in whom aspirin or other NSAID drugs induce the syndrome of asthma, rhinitis, and nasal polyps.
  • Subject is pregnant, actively trying to become pregnant, or breast-feeding.
  • Subject is of childbearing potential and not using adequate contraceptive measures.
  • Subject has a recent history (in the past 3 months) suggestive of alcohol or drug abuse or dependence, including overuse (abuse) of ergotamines and/or narcotics to treat migraines. Ergotamine abuse is daily use for 14 consecutive days or intermittent consumption exceeding 10 mg per week for any two weeks.
  • Subject has participated in an investigational drug trial within the previous four weeks or plans to participate in another study at any time during the period of this study.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Pozen, Inc.

    Chapel Hill, North Carolina, 27517

  • Nashville Neuroscience Group, PC

    Nashville, Tennessee, 37203

Other trials in United States

About this study

Official title: A Double-Blind Multicenter, Randomized, Placebo-Controlled Single Dose Study to Evaluate the Safety and Efficacy of Trexima in the Acute Treatment of Migrane Headaches

  • to demonstrate the superiority of Trexima (combination of sumatriptan as the succinate 85 mg and naproxen sodium 500 mg) versus placebo in the acute treatment of migraine
  • to demonstrate the superiority of Trexima versus the individual components (sumatriptan as the succinate 85 mg and naproxen sodium 500 mg), and
  • to evaluate the safety of the Trexima.
Being tested
sumatriptan, naproxen sodium
Keywords
TREXIMA, MIGRAINE HEADACHES, Subjects may be enrolled if they are 18-65 years of age, have a demonstrated history of migraine headaches
Medical subject headings
Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sumatriptanDrug

  • naproxen sodiumDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Trexima will be evaluated for efficacy as an acute treatment for migraine based on its superiority over placebo at 2 hours for: a) pain relief (no or mild pain), b) incidence of photophobia, c) incidence of phonophobia and d) incidence of nausea.

Secondary outcomes (1)

  1. a) sustained pain relief over 24 hours, b) sustained photophobia-free over 24 hours, c) sustained phonophobia-free over 24 hours, and d) sustained nausea-free over 24 hours.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2007 (estimated)
  2. Study startJul 2004
  3. Study completionJan 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
1,200 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00434083
Sponsor's protocol ID
MT400-301
Status last verified
Feb 2007
First submitted
8 Feb 2007
Last updated
12 Feb 2007
Results posted
No

Publications

  • 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. doi: 10.1001/jama.297.13.1443.

    PubMed 17405970

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing sumatriptan and naproxen sodium in people with Migraine Headaches, run by POZEN at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Trexima will be evaluated for efficacy as an acute treatment for migraine based on its superiority over placebo at 2 hours for: a) pain relief (no or mild pain), b) incidence of photophobia, c) incidence of phonophobia and d) incidence of nausea.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00434083, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2007.

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