Does Treximet Improve Productivity and Patient Satisfaction Due to Sustained Response and Consistency of Response?

NCT01086358 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 09-602
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Researchers want to learn about work productivity after treatment of a migraine headache with your usual migraine medication as compared to your work productivity after treatment with Treximet. During this research subjects will take Treximet to treat 3 workday migraine attacks. For a second part of the research subjects will take their usual prescribed medication for 3 workday migraine attacks. The subjects will complete questionnaires after treating each migraine.

Conditions

Workplace Migraine Treatment

Keywords

Productivity; Migraine; Treximet; Triptan

Outcome Measures

Primary Outcomes (1)

• Workplace Productivity and Activity Impairment Scale (WPAI).

  The primary outcome measure was lost productivity (workplace productivity + non-workplace activity time) as measured by a variant of the Work Productivity and Activity Impairment Scale (WPAI) at 6 months. The primary efficacy dataset included the 37 patients that completed both phases of the study and uses the last observed headache. The unit of analysis is hours lost. The higher the score the greater impact on productivity. The range depends on the length of the attack, but in the sample among all observed attacks, lost work productivity ranged from 0-10.5 hours, while lost non-workplace activity time ranged from 0 to 8.95 hours. The total lost productivity is the sum of lost work productivity and lost non-workplace activity time.

  6 months

Secondary Outcomes (3)

• Lost Workplace Productivity

  6 months

• Lost Activity Time

  6 Months

• Favorable Response on Migraine-ACT

  6 months

Study Arms (2)

Triptan

ACTIVE COMPARATOR

Arm 1 subjects began with their prescribed triptan

Drug: Triptan

Treximet 85Mg-500Mg Tablet

ACTIVE COMPARATOR

Arm 2 subjects began with Treximet (sumatriptan 85 mg/naproxen sodium 500 mg)

Drug: Treximet 85Mg-500Mg Tablet

Interventions

Triptan DRUG

Usual prescribed triptans may include:sumatriptan, rizatriptan, naratriptan, almotriptan, eletriptan, zolmitriptan

Also known as: Sumatriptan,rizatriptan,naratriptan,almotriptan,eletriptan,zolmitriptan

Triptan

Treximet 85Mg-500Mg Tablet DRUG

Treximet is 85 mg sumatriptan plus 500 mg naproxen sodium

Also known as: Sumatriptan 85 mg plus naproxen sodium 500 mg

Treximet 85Mg-500Mg Tablet

Eligibility Criteria

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

You may qualify if:

• episodic migraine diagnosis
• age 18 or older
• currently using a triptan as primary migraine monotherapy
• currently employed
• if of childbearing potential, willing to prevent pregnancy during study participation
• able to understand and consent to study participation

You may not qualify if:

• younger than age 18
• not having episodic migraine diagnosis
• not using a triptan as primary migraine monotherapy
• not currently employed
• pregnant or nursing or unwilling to prevent pregnancy during study participation
• unable to understand and consent to study participation

Sponsors & Collaborators

• The Cleveland Clinic: lead
• GlaxoSmithKline: collaborator
• Currax Pharmaceuticals: collaborator

Study Sites (1)

Cleveland Clinic, 9500 Euclid Avenue, C-21

Cleveland, Ohio, 44195, United States

Location

Related Publications (4)

• Mathew NT, Landy S, Stark S, Tietjen GE, Derosier FJ, White J, Lener SE, Bukenya D. Fixed-dose sumatriptan and naproxen in poor responders to triptans with a short half-life. Headache. 2009 Jul;49(7):971-82. doi: 10.1111/j.1526-4610.2009.01458.x. Epub 2009 May 27.

  PMID: 19486178 BACKGROUND

• Dowson AJ, Tepper SJ, Baos V, Baudet F, D'Amico D, Kilminster S. Identifying patients who require a change in their current acute migraine treatment: the Migraine Assessment of Current Therapy (Migraine-ACT) questionnaire. Curr Med Res Opin. 2004 Jul;20(7):1125-35. doi: 10.1185/030079904125004079.

  PMID: 15265257 BACKGROUND

• Cleves C, Tepper SJ. Sumatriptan/naproxen sodium combination for the treatment of migraine. Expert Rev Neurother. 2008 Sep;8(9):1289-97. doi: 10.1586/14737175.8.9.1289.

  PMID: 18759540 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

MeSH Terms

Conditions

Migraine Disorders

Interventions

Tryptamines; Sumatriptan; sumatriptan-naproxen; Naproxen

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

Unusually high number of subjects lost to follow-up.

Results Point of Contact

• Title: Jennifer Kriegler, MD
• Organization: Cleveland Clinic Foundation

krieglj@ccf.org

216-444-8265

Study Officials

• Jennifer S Kriegler, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This was a randomized, open-label, 6-attack (3-attacks per arm) crossover design in which subjects were randomized to threat their first 3 workplace migraines with sumatriptan/naproxen sodium or with their usual triptan monotherapy before treating their subsequent 3 workplace migraines with the opposite medication.

Study Record Dates

• First Submitted: March 11, 2010
• First Posted: March 15, 2010
• Study Start: September 1, 2009
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: May 1, 2018
• Results First Posted: May 1, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)