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

NCT00434083 | Completed Phase 3

• 1 other identifier: MT400-301
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 2

Brief 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 evaluate the safety of the Trexima.

Conditions

Migraine Headaches

Keywords

TREXIMA; MIGRAINE HEADACHES; Subjects may be enrolled if they are 18-65 years of age, have a demonstrated history of migraine headaches

Outcome Measures

Primary Outcomes (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)

• 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.

Interventions

sumatriptan DRUG

naproxen sodium DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• POZEN: lead

Study Sites (2)

Pozen, Inc.

Chapel Hill, North Carolina, 27517, United States

Location

Nashville Neuroscience Group, PC

Nashville, Tennessee, 37203, United States

Location

Related Publications (1)

• 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.

  PMID: 17405970 DERIVED

MeSH Terms

Conditions

Migraine Disorders

Interventions

Sumatriptan; Naproxen

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• David Taylor

  POZEN

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 8, 2007
• First Posted: February 12, 2007
• Study Start: July 1, 2004
• Study Completion: January 1, 2005
• Last Updated: February 12, 2007

Record last verified: 2007-02

Locations

US (2)