"Completeness of Response" Following Treatment With Treximet™ for Migraine

NCT00893737 | Completed Phase 4 Results

• 1 other identifier: 110211
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 8

Brief Summary

Many clinical trials may not fully explore criteria that are important to some migraine patients' definition of "complete response." This study offers the opportunity to evaluate the effectiveness of Treximet™ when non-standard criteria are examined (for example, neck pain, irritability or fatigue). Subjects enrolled at 8 investigative sites will complete 2 visits. Subjects will complete a Completeness of Response Survey at Visit 1 considering their usual migraine medication (a triptan) and a Completeness of Response Survey at Visit 2 considering their study medication (Treximet™).

Conditions

Migraine

Keywords

Migraine; Headache, Migraine

Outcome Measures

Primary Outcomes (1)

• Change in Scores From Completeness of Response Survey (CORS)

  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).

  Visit 1 (screening) and Visit 2 (study completion following 2-month treatment period)

Secondary Outcomes (2)

• Percent of Participants Reporting Treximet Provides Therapeutic Advantage Over Usual Pre-study Triptan

  Visit 1 (screening) and Visit 2 (study completion following 2-month treatment period)

• 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)

  Visit 1 (screening) and Visit 2 (study completion following 2-month treatment period)

Study Arms (1)

Treximet

EXPERIMENTAL

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.

Drug: sumatriptan succinate 85 mg/naproxen sodium 500 mg (Treximet)

Interventions

sumatriptan succinate 85 mg/naproxen sodium 500 mg (Treximet) DRUG

Treximet 1 tablet as soon as the patient has headache indicative of migraine. May be repeated between 2 and 24 hours post-treatment for persistent or recurring headache. Subjects should not take more than 2 Treximet tablets in 24 hours.

Treximet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be/have
• age 18 to 65
• able to read, understand, and sign informed consent
• willing to record migraine headaches and response to treatment in diary
• diagnosis of migraine headache (IHS 1.1 or 1.2), without and/or with aura
• at least one year history of migraine
• attacks per month in past 3 months
• onset of migraine before age 50
• current triptan user (treated with triptan as primary migraine therapy at least 2 times per month in 3 months prior to screening)
• history of migraine starting at mild pain for at least 75% of migraine attacks
• use reliable method of birth control if female and childbearing potential (i.e. reliable barrier method, oral contraceptive, implant, contraceptive patch, long term injectable contraceptive, intrauterine device or tubal ligation)
• on stabilized dosages of current concomitant medications at least 90 days (may include migraine preventive medications), and willing to continue during study period

You may not qualify if:

• Subject has/is
• history of serotonin syndrome
• medical condition that, in opinion of the investigator, could confound results of the study
• female of childbearing potential not using adequate contraceptive measures
• or more headache days per month in total, or history of retinal,, basilar or hemiplegic migraine, cluster headache, or secondary headaches (such as due to trauma, infection, alterations of homeostasis, ENT or psychiatric disorders, cranial or cervical disorders or neuralgias)
• in investigator's opinion, is likely to have unrecognized cardiovascular or cerebrovascular disease (based on history or presence of risk factors including but not limited to, hypertension, hypercholesterolemia, smoker, obesity, diabetes, or family history of coronary artery disease)
• blood pressure ≥ 140/90 mmHg in 2 of 3 BP measurements at screening or is taking any angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker
• a history of congenital heart disease, cardiac arrhythmias requiring medication, or history of clinically significant electrocardiogram abnormality that, in investigator's opinion, contraindicates participation in this study
• evidence or history of ischemic vascular disease including: ischemic heart disease, ischemic abdominal syndromes, peripheral vascular disease or Raynaud's Syndrome, or signs/symptoms consistent with any of above
• evidence or history of central nervous system pathology including stroke and/or transient ischemic attacks (TIAs), epilepsy or structural brain lesions which lower convulsive threshold; or has been treated with antiepileptic drug for seizure control within 5 years prior to screening
• history of impaired hepatic or renal function that, in investigator's opinion, contraindicates participation in study
• hypersensitivity, intolerance, or contraindication to use of any triptan, NSAID or aspirin (including all sumatriptan and naproxen preparations) or has nasal polyps and asthma
• currently taking, or has taken in previous three months, migraine prophylactic medication containing methysergide; or is taking migraine or menstrual migraine prophylactic medication that is not stabilized (i.e., change of dose within the past 2 months)
• recent history of regular use of opioids or barbiturates for treatment of migraine headache and/or other non-migraine pain (regular use defined as an average of 4 days per month over 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 2 weeks prior to screening through 2 weeks post final study treatment

Sponsors & Collaborators

• Cady, Roger, M.D.: lead
• GlaxoSmithKline: collaborator

Study Sites (8)

San Francisco Clinical Research Center

San Francisco, California, 94109, United States

Location

Westside Family Medical Center

Kalamazoo, Michigan, 49009, United States

Location

Clinvest

Springfield, Missouri, 65807, United States

Location

Mercy Health Research/Ryan Headache Center

St Louis, Missouri, 63141, United States

Location

Island Neurological Associates, PC

Plainview, New York, 11803, United States

Location

Preferred Primary Care Physicians

Pittsburgh, Pennsylvania, 15236, United States

Location

Wesley Headache Clinic and Research Center

Cordova, Tennessee, 38018, United States

Location

Texas Headache Associates

San Antonio, Texas, 78258, United States

Location

Related Publications (4)

• 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. doi: 10.1111/j.1526-4610.2005.05178.x.

  PMID: 16109111 BACKGROUND

• 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 BACKGROUND

• Silberstein SD. Practice parameter: evidence-based guidelines for migraine headache (an evidence-based review) [RETIRED]: report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2000 Sep 26;55(6):754-62. doi: 10.1212/wnl.55.6.754. No abstract available.

  PMID: 10993991 BACKGROUND

• Cady R, Banks J, Nett RB, Goldstein J, Bennett N, Turner IM, Ruoff GE, Landy SH, Farmer K, Juhasz M, Tarrasch J, Runken MC. Multi-center comparison of response to a single tablet of sumatriptan 85 mg and naproxen 500 mg vs usual therapy treating multiple migraine attacks as measured by the completeness of response survey. Headache. 2011 Jun;51(6):961-70. doi: 10.1111/j.1526-4610.2011.01912.x. Epub 2011 May 17.

  PMID: 21592098 DERIVED

MeSH Terms

Conditions

Migraine Disorders

Interventions

Sumatriptan; Naproxen; 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

Results Point of Contact

• Title: Rebecca Browning
• Organization: Clinvest

rbrowning@clinvest.com

(417) 841-3664

Study Officials

• Roger K Cady, MD

  Clinvest

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDIV

Study Record Dates

• First Submitted: May 5, 2009
• First Posted: May 6, 2009
• Study Start: June 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: January 25, 2011
• Results First Posted: January 25, 2011

Record last verified: 2011-01

Locations

US (8)