Treximet in the Treatment of Chronic Migraine

NCT01090050 | Completed Phase 4 Results

• 1 other identifier: 112839
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 2

Brief Summary

This study is being conducted to evaluate the hypothesis that use of Treximet in patients with chronic migraine, when used on a short term daily basis and as rescue for break through attacks, will reduce migraine frequency and impact.

Conditions

Chronic Migraine

Keywords

Chronic Migraine; Migraine; Treximet; naproxen; sumatriptan

Outcome Measures

Primary Outcomes (1)

• Percent Change of Migraine Headache Days Compared to Baseline

  Comparing the number of migraine headache days during Baseline Period days 1-30 to number of migraine headache days reported in Treatment Period days 91-120 in the Sumatriptan/Naproxen Sodium arm versus (vs.) Naproxen Sodium arm. Percent change=\[(total headache days during Treatment Period Month 3(days 91-120)-total headache days during Baseline(days 1-30)/total headache days during Baseline(days 1-30)\]\*100%)

  Day 121 (following 30 day Baseline Period and Treatment Period days 91-120.

Secondary Outcomes (7)

• Percent Change of Migraine Headache Days in All Treatment Periods Compared to Baseline

  Baseline Period (days 1-30) collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121, respectively.

• Migraine Headache Duration From Onset to Pain Free

  Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121 respectively.

• Migraine Headache Duration From Time of Treatment to Pain Free

  Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121 respectively.

• Migraine Headache Days With Greater Than 50% Reduction

  Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 92, and 121 respectively.

• Percent Change of Doses of Study Medication

  Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 92, and 121 respectively.

Study Arms (2)

Sumatriptan/Naproxen Sodium

ACTIVE COMPARATOR

In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen Sodium will treat daily with 1 tablet Sumatriptan 85mg / Naproxen Sodium 500mg per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue.

Drug: Sumatriptan/Naproxen Sodium

Naproxen Sodium

ACTIVE COMPARATOR

In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium 500mg per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue.

Drug: Naproxen Sodium

Interventions

Sumatriptan/Naproxen Sodium DRUG

Each tablet of Sumatriptan/Naproxen Sodium for oral administration contains sumatriptan 85mg / naproxen sodium 500mg. Study medication is to be administered 1 tablet per day x 30 days in Treatment Period Month 1. Study medication may be administered on up to 14 days per month in Treatment Period Months 2 and 3.

Also known as: Treximet

Sumatriptan/Naproxen Sodium

Naproxen Sodium DRUG

Each tablet of Naproxen Sodium for oral administration is provided in 500mg tablet. Study medication is to be administered 1 tablet per day x 30 days in Treatment Period Month 1. Study medication may be administered on up to 14 days per month in Treatment Period Months 2 and 3.

Naproxen Sodium

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 male or female, in otherwise good health, 18 to 65 years of age.
• Has history of chronic migraine (with or without aura) according to the criteria proposed by the Headache Classification Committee of the International Headache Society for at least 3 months prior to enrollment.
• Has onset of migraine before age 50.
• Is able to differentiate migraine from any other headache they may experience (e.g., tension-type headache).
• Has stable history of headache for at least 3 months prior to screening.
• Is not currently taking a migraine preventive or has been taking preventive for at least 30 days prior to screening and agrees to not start, stop, or change medication and/or dosage during the study period.
• If female of childbearing potential, has a negative urine pregnancy test at Visit 1 and uses, or agrees to use, for the duration of the study, a medically acceptable form of contraception as determined by the investigator.
• Complete abstinence from intercourse from 2 weeks prior to administration of study drug throughout the study, and for a time interval after completion or premature discontinuation from the study to account for elimination of the study drug (a minimum of 7 days); or,
• Surgically sterile (hysterectomy or tubal ligation or otherwise incapable of pregnancy); or,
• Sterilization of male partner; or,
• Intrauterine device with published data showing lowest expected failure rate is less than 1% per year; or,
• Double barrier method (i.e., 2 physical barriers OR 1 physical barrier plus spermicide) for a least 1 month prior to Visit 1 and throughout study; or,
• Hormonal contraceptives for at least 3 months prior to Visit 1 and throughout study.

You may not qualify if:

• Subject
• Is unable to understand the study requirements, the informed consent, or complete headache records as required per protocol.
• Is pregnant, actively trying to become pregnant, or breast-feeding.
• Has experienced the following migraine variants: basilar migraine, aura without headache, familial hemiplegic migraine, complicated migraine, ophthalmoplegic migraine and retinal migraine.
• Has a history of Medication Overuse Headache in the 3 months prior to study enrollment or during the Baseline Period.
• Has abused, in the opinion of the Investigator, any of the following drugs, currently or within the past 1 year: opioids, alcohol, barbiturates, benzodiazepine, cocaine
• Has an unstable neurological condition or a significantly abnormal neurological examination with focal signs or signs of increased intracranial pressure.
• Suffers from cardiovascular disease (ischemic heart disease, including angina pectoris, myocardial infarction, documented silent ischemia, or with Prinzmetal's angina); has symptoms of ischemic heart disease; have uncontrolled hypertension; has electrocardiogram (ECG) results outside normal limits for clinically stable patients as judged by the investigator.
• Has a history of asthma, allergy, or nasal polyps developing for the first time over the age of 40.
• Has a history of peptic ulcer disease requiring therapeutic intervention in the year prior to study enrollment.
• Has a history of bleeding peptic ulcer disease or perforation of the stomach or intestine.
• Has a history of bleeding disorder.
• Has history of Non-steroidal anti-inflammatory drug (NSAID) induced gastritis, esophagitis, or duodenitis.
• Suffers from a serious illness, or an unstable medical condition that could require hospitalization, or could increase the risk of adverse events.
• Has significant (as determined by the investigator) cardiovascular risk factors that may include uncontrolled high blood pressure, post-menopausal women, males over 40 years old, hypercholesterolemia, obesity, diabetes mellitus, smoking, or a family history of cardiovascular disease in a 1st degree relative.

Sponsors & Collaborators

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

Study Sites (2)

Clinvest

Springfield, Missouri, 65807, United States

Location

Texas Headache Associates

San Antonio, Texas, 78258, United States

Location

Related Publications (1)

• Cady R, Nett R, Dexter K, Freitag F, Beach ME, Manley HR. Treatment of chronic migraine: a 3-month comparator study of naproxen sodium vs SumaRT/Nap. Headache. 2014 Jan;54(1):80-93. doi: 10.1111/head.12210. Epub 2013 Sep 10.

  PMID: 24020994 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: Jeanne Tarrasch
• Organization: Clinvest/A Division of Banyan Group Inc.

jtarrasch@clinvest.com

417-841-3673

Study Officials

• Roger K Cady, MD

  Clinvest

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2010
• First Posted: March 19, 2010
• Study Start: September 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: July 1, 2012
• Last Updated: July 3, 2013
• Results First Posted: July 3, 2013

Record last verified: 2013-05

Locations

US (2)