Treximet for Prevention of Post Traumatic Headache Associated With Cognitive Dysfunction

NCT01053507 | Terminated Phase 4 Results

• 1 other identifier: 114126
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 3

Brief Summary

This study will evaluate the effectiveness of Treximet when taken for post traumatic headache by measuring any change in the number of headache days or any change in a subject's ability to think following treatment with study medication. Eligible subjects will complete 3 visits. Following Visit 1, subjects will treat with their usual medication and document headache symptoms and therapy in a Headache Diary. After 30 days, subjects will return for Visit 2 and be randomized (like the flip of a coin) to receive Treximet or matching placebo to treat at the same time each day. Treximet will be provided to treat any headache that occurs. Subjects will complete a daily Diary. After 30 days, subjects will exit the study at Visit 3.

Conditions

Post-Traumatic Headache

Keywords

Headache; Post-traumatic headache; Brain injury; Cognitive impairment

Outcome Measures

Primary Outcomes (2)

• Headache Days

  Change in number of headache days at Day 0 vs. Day 30 in Treximet arm vs. Placebo arm.

  Day 0, Day 30

• Change in Number of Associated Headache Symptoms

  Change in number of associated headache symptoms at Day 0 vs. Day 30 in Treximet arm vs. Placebo arm. Associated headache symptoms measured included number of incidences of: sleeplessness, difficulty thinking, and bodily pain.

  Day 0, Day 30

Secondary Outcomes (3)

• Mental Efficiency Workload Test (MEWT) Performance Index

  Day 0, Day 30

• Headache Impact Test-6 (HIT-6) Score

  Day 0, Day 30

• Migraine Specific Quality of Life Questionnaire (MSQ)

  Day 0, Day 30

Study Arms (2)

Treximet

ACTIVE COMPARATOR

In the 30-day Treatment Period, subjects randomized to Treximet will treat with 1 tablet Treximet (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days.

Drug: sumatriptan/naproxen sodium

Placebo

PLACEBO COMPARATOR

In the 30-day Treatment Period, subjects randomized to placebo will treat with 1 tablet placebo x 30 days. Placebo matches Treximet.

Drug: Placebo

Interventions

sumatriptan/naproxen sodium DRUG

Each tablet of Treximet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg. Study medication is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period.

Also known as: Treximet

Treximet

Placebo DRUG

Each tablet of placebo for oral administration matches Treximet. Placebo is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period.

Placebo

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 between the ages of 18-65. A female is eligible to enter and participate in this study if she is of: a.non-childbearing potential (i.e., physiologically incapable of becoming pregnant); or,b. child-bearing potential, has a negative pregnancy test (urine or serum) at Visit 2, and agrees to one of the following: Complete abstinence from intercourse from 2 weeks prior to administration of the investigational product, throughout the study, and for a time interval (5 days) after completion or premature discontinuation from the study to account for elimination of the investigational drug; 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 when they present to the clinic for the final visit 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 highest expected failure rate is less than 1% per year (not all IUDs meet this criterion); or, Spermicide plus a mechanical barrier (e.g., spermicide plus a male condom or a female diaphragm); or, Any other barrier methods (only if used in combination with any of the above acceptable methods); or, Any other methods with published data showing that the highest expected failure rate for that method is less than 1% per year.
• is formally diagnosed with International Classification of Headache Disorders (ICHD) 5.2.2 chronic post traumatic headache
• has \>15 headache days per month in past 3 months
• has headache that, if left untreated, would have at least 1 symptom of migraine (nausea, vomiting, photophobia, or phonophobia) or respond to a triptan or ergotamine-containing medication with at least 50% of headaches
• is medically stable as determined by the Investigator
• if taking a headache preventive medication, has been on a stabilized dosage for at least 30 days prior to screening.
• if taking any concomitant medications, is on a stabilized dosage at the discretion of the investigator
• has chronic headache history only after the traumatic brain injury (TBI)
• is able to understand and communicate intelligibly with the study observer
• is able to take oral medication, adhere to the medication regimens and perform study procedures
• is able to read and comprehend written instructions and be willing to complete all procedures and assessments required by this protocol
• is able to demonstrate the willingness to participate by signing and understanding an informed consent after full explanation of the study
• has self-reported cognitive inefficiency or "brain-fog" during headache

You may not qualify if:

• Subject
• has a history of serotonin syndrome
• has any medical condition that, in the opinion of the investigator, could alter the response to study medication or confound the results of the study
• is female of childbearing potential not using adequate contraceptive measures
• has history of retinal, basilar or hemiplegic migraine, cluster headache, or secondary headaches (such as due to infection, alterations of homeostasis, ear nose and throat (ENT) or psychiatric disorders, cranial or cervical disorders or neuralgias)
• in the investigator's opinion, is likely to have unrecognized cardiovascular or cerebrovascular disease (based on history or the presence of risk factors including but not limited to, hypertension, hypercholesterolemia, smoker, obesity, diabetes, or family history of coronary artery disease)
• has blood pressure ≥140/90 millimeters of mercury (mmHg) in 2 out of 3 BP measurements at screening or is taking any angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker
• has a history of significant congenital heart disease, cardiac arrhythmias requiring medication, or a history of a clinically significant electrocardiogram abnormality that, in the investigator's opinion, contraindicates participation in this study
• has evidence or history of any ischemic vascular diseases including: ischemic heart disease, ischemic abdominal syndromes, peripheral vascular disease or Raynaud's Syndrome, or signs/symptoms consistent with any of the above
• has evidence or history of central nervous system pathology including stroke and/or transient ischemic attacks (TIAs), epilepsy or structural brain lesions which lower the convulsive threshold; or has been treated with an antiepileptic drug for seizure control within 5 years prior to screening
• has a history of impaired hepatic or renal function that, in the investigator's opinion, contraindicates participation in this study
• has hypersensitivity, intolerance, or contraindication to the use of any triptan, nonsteroidal antiinflammatory drug (NSAID) or aspirin (including all sumatriptan and naproxen preparations) or has nasal polyps and asthma
• is currently taking, or has taken in the previous three months, a migraine prophylactic medication containing methysergide; or is taking a migraine or menstrual migraine prophylactic medication that is not stabilized (i.e. start or change of dose within 30 days prior to screening)
• has a recent history of regular use of opioids or barbiturates for treatment of their migraine headache and/or other non-migraine pain or any medication overuse that in the opinion of the investigator has exacerbated or contributed to the current headache pattern of the subject.
• has taken, or plans to take, a monoamine oxidase inhibitor (MAOI), including herbal preparations containing St. John's Wort (Hypericum perforatum), anytime within the 2 weeks prior to screening through 2 weeks post final study treatment.

Sponsors & Collaborators

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

Study Sites (3)

Clinvest

Springfield, Missouri, 65807, United States

Location

Nashville Neuroscience Group, PC

Nashville, Tennessee, 37203, United States

Location

Scott & White Memorial Hospital and Clinic

Temple, Texas, 76508, United States

Location

Related Publications (3)

• Baandrup L, Jensen R. Chronic post-traumatic headache--a clinical analysis in relation to the International Headache Classification 2nd Edition. Cephalalgia. 2005 Feb;25(2):132-8. doi: 10.1111/j.1468-2982.2004.00818.x.

  PMID: 15658950 BACKGROUND

• Headache Classification Subcommittee of the International Headache Society. The International Classification of Headache Disorders: 2nd edition. Cephalalgia. 2004;24 Suppl 1:9-160. doi: 10.1111/j.1468-2982.2003.00824.x. No abstract available.

  PMID: 14979299 BACKGROUND

• Cady R, Farmer K. Soft tissue injuries: diagnosis and treatment. Posttraumatic headache. In Windsor R, Lox D (eds.) Hanley and Belfus, Inc. Philadelphia, PA. 207-224.

  BACKGROUND

MeSH Terms

Conditions

Post-Traumatic Headache; Headache; Brain Injuries; Cognitive Dysfunction

Interventions

Sumatriptan; Naproxen; sumatriptan-naproxen

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

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: Dr. Roger K. Cady
• 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
• Restrictive Agreement: No

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 19, 2010
• First Posted: January 21, 2010
• Study Start: May 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: July 29, 2020
• Results First Posted: March 10, 2014

Record last verified: 2020-07

Locations

US (3)