Treximet Trademark (TM) in the Prevention and Modification of Disease Progression in Migraine

NCT01300546 | Completed Phase 4 Results

• 1 other identifier: 114933
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

This study is being conducted to evaluate the hypothesis that use of pharmacological and non-pharmacological interventions may allow subjects at high risk for chronic migraine to avoid or reverse the transformation of episodic migraine to chronic migraine.

Conditions

Migraine

Keywords

Frequent migraine; Migraine transformation; Migraine; Treximet; Naproxen; Sumatriptan

Outcome Measures

Primary Outcomes (1)

• Percent Change of Headache Days Compared to Baseline

  Comparing the number of migraine headache days during Baseline Period Days 1-30 to number or migraine headache days reported in Treatment Period Days 91-120 in Sumatriptan/Naproxen Sodium arm 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 (11)

• Migraine Attacks

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

• Migraine Severity

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

• Migraine 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.

• Migraine 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.

• Headache Days With Greater Than 50% Reduction

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

Study Arms (2)

Sumatriptan/Naproxen Sodium

ACTIVE COMPARATOR

In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.

Drug: Sumatriptan/Naproxen Sodium

Naproxen Sodium

ACTIVE COMPARATOR

In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.

Drug: Naproxen Sodium

Interventions

Sumatriptan/Naproxen Sodium DRUG

Each tablet of Treximet for oral administration contains Sumatriptan 85mg / Naproxen Sodium 500mg. Study medication is to be administered within 1 hour of migraine onset on 14 or fewer days per month in the Treatment Period.

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 within 1 hour of migraine onset on 14 or fewer days per month in the Treatment Period.

Also known as: Naproxen

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 frequent episodic migraine (6-14 migraine days per month) (with or without aura) according to the 2nd Edition of The International Headache Classification (ICHD-2) for at least 3 months. (Stage 2-3 frequent transforming migraine)
• Had 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 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.
• Has at least 50% of migraine attacks beginning at mild severity.
• If female of childbearing potential, has a negative urine pregnancy test at Visits 1-5 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 phase
• Has history of acute migraine treatment greater than14 days per month in 3 months prior to screening.
• 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 history of impaired hepatic or renal function that, in the investigator's opinion, contraindicates participation in this study.
• 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, ischemic abdominal syndromes, peripheral vascular disease or Raynaud's Syndrome; has uncontrolled hypertension (≥140/90 millimeters of mercury (mmHg) in 2 out of 3 blood pressure (BP) measurements at screening); has electrocardiogram (ECG) results outside normal limits for clinically stable patients as judged by the investigator.

Sponsors & Collaborators

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

Study Sites (2)

Newport Beach Clinical Research Assoc., Inc.

Newport Beach, California, 92663, United States

Location

Clinvest

Springfield, Missouri, 65807, United States

Location

Related Publications (9)

• Cady RK, Goldstein J, Silberstein S, Juhasz M, Ramsey K, Rodgers A, Hustad CM, Ho T. Expanding access to triptans: assessment of clinical outcome. Headache. 2009 Nov-Dec;49(10):1402-13. doi: 10.1111/j.1526-4610.2009.01532.x. Epub 2009 Oct 8.

  PMID: 19817885 BACKGROUND

• Cady RK, Martin VT, Geraud G, Rodgers A, Zhang Y, Ho AP, Hustad CM, Ho TP, Connor KM, Ramsey KE. Rizatriptan 10-mg ODT for early treatment of migraine and impact of migraine education on treatment response. Headache. 2009 May;49(5):687-96. doi: 10.1111/j.1526-4610.2009.01412.x.

  PMID: 19472447 BACKGROUND

• Bigal ME, Sheftell FD, Rapoport AM, Lipton RB, Tepper SJ. Chronic daily headache in a tertiary care population: correlation between the International Headache Society diagnostic criteria and proposed revisions of criteria for chronic daily headache. Cephalalgia. 2002 Jul;22(6):432-8. doi: 10.1046/j.1468-2982.2002.00384.x.

  PMID: 12133042 BACKGROUND

• Headache Classification Committee; Olesen J, Bousser MG, Diener HC, Dodick D, First M, Goadsby PJ, Gobel H, Lainez MJ, Lance JW, Lipton RB, Nappi G, Sakai F, Schoenen J, Silberstein SD, Steiner TJ. New appendix criteria open for a broader concept of chronic migraine. Cephalalgia. 2006 Jun;26(6):742-6. doi: 10.1111/j.1468-2982.2006.01172.x.

  PMID: 16686915 BACKGROUND

• Lipton RB, Stewart WF, Cady R, Hall C, O'Quinn S, Kuhn T, Gutterman D. 2000 Wolfe Award. Sumatriptan for the range of headaches in migraine sufferers: results of the Spectrum Study. Headache. 2000 Nov-Dec;40(10):783-91. doi: 10.1046/j.1526-4610.2000.00143.x.

  PMID: 11135021 BACKGROUND

• Newman LC, Lipton RB, Lay CL, Solomon S. A pilot study of oral sumatriptan as intermittent prophylaxis of menstruation-related migraine. Neurology. 1998 Jul;51(1):307-9. doi: 10.1212/wnl.51.1.307.

  PMID: 9674831 BACKGROUND

• Foley KA, Cady R, Martin V, Adelman J, Diamond M, Bell CF, Dayno JM, Hu XH. Treating early versus treating mild: timing of migraine prescription medications among patients with diagnosed migraine. Headache. 2005 May;45(5):538-45. doi: 10.1111/j.1526-4610.2005.05107.x.

  PMID: 15953272 BACKGROUND

• Rapoport AM, Bigal ME, Volcy M, Sheftell FD, Feleppa M, Tepper SJ. Naratriptan in the preventive treatment of refractory chronic migraine: a review of 27 cases. Headache. 2003 May;43(5):482-9. doi: 10.1046/j.1526-4610.2003.03094.x.

  PMID: 12752754 BACKGROUND

• Sheftell FD, Rapoport AM, Tepper SJ, Bigal ME. Naratriptan in the preventive treatment of refractory transformed migraine: a prospective pilot study. Headache. 2005 Nov-Dec;45(10):1400-6. doi: 10.1111/j.1526-4610.2005.00273.x.

  PMID: 16324173 BACKGROUND

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: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2011
• First Posted: February 21, 2011
• Study Start: December 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: May 21, 2013
• Results First Posted: May 21, 2013

Record last verified: 2013-05

Locations

US (2)