Post-Traumatic HeadachePhase 4NCT01053507
Treximet for Prevention of Post Traumatic Headache Associated With Cognitive Dysfunction
A Phase 4 study testing sumatriptan/naproxen sodium in people with Post-Traumatic Headache, run by Cady, Roger, M.D. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-Traumatic Headache
- What is being tested?
- sumatriptan/naproxen sodium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2010to Nov 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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)
Show all 20Show fewer
- 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.
- has history of any bleeding disorder or is currently taking any anti-coagulant or any antiplatelet agent.
- has evidence or history of any gastrointestinal surgery or GI ulceration or perforation in the past six months, gastrointestinal bleeding in the past year; or evidence or history of inflammatory bowel disease
- is pregnant, actively trying to become pregnant, or breast feeding
- has evidence of alcohol or substance abuse within the last year or any concurrent medical or psychiatric condition which, in the investigator's judgment, will likely interfere with the study conduct, subject cooperation, or evaluation and interpretation of the study results, or which otherwise contraindicates participation in this clinical trial.
- has participated in an investigational drug trial within the previous four weeks or plans to participate in another study at any time during this study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Nashville Neuroscience Group, PC
Nashville, Tennessee, 37203
Clinvest
Springfield, Missouri, 65807
Scott & White Memorial Hospital and Clinic
Temple, Texas, 76508
About this study
Official title: Evaluation of the Efficacy of Treximet for Prevention of Post Traumatic Headache Associated With Cognitive Dysfunction
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.
Read the detailed description
Subjects will be enrolled at 3 investigative sites. At Visit 1, a medical, headache, and medication history will be collected and a physical and neurological exam with vital signs will be performed. An ECG will be completed if one has not been completed in the previous 6 months. Subjects will be administered a series of psychological tests to help the study doctor decide whether or not a subject is eligible. The Headache Impact Test-6 and Migraine Specific Quality of Life Questionnaire will be completed at each visit. During a 30-day Baseline Period, subjects will treat with their usual medication and complete a daily Diary documenting headache symptoms and treatment. At Visits 2 and 3 subjects will complete the Mental Efficiency Workload Test and Migraine Early Warning Tool. Following randomization at Visit 2, subjects will treat daily for 30 days with Treximet or a matching placebo. Subjects will be provided with Treximet for rescue of any persisting or recurring headache. During the Treatment Period, subjects will complete a daily Diary reporting headache symptoms and response to treatment. After the 30-day Treatment Period, subjects will exit the study at Visit 3 .
- Conditions
- Post-Traumatic Headache
- Being tested
- sumatriptan/naproxen sodium, Placebo
- Keywords
- Headache, Post-traumatic headache, Brain injury, Cognitive impairment
- Medical subject headings
- Post-Traumatic Headache, Headache, Brain Injuries, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sumatriptan/naproxen sodiumDrug
Also called Treximet
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache Days
Change in number of headache days at Day 0 vs. Day 30 in Treximet arm vs. Placebo arm.
Measured: 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.
Measured: Day 0, Day 30
Secondary outcomes (3)
Mental Efficiency Workload Test (MEWT) Performance Index
The Mental Efficiency Workload Test (MEWT) performance index is a scale with minimum and maximum values of 1 to 10, 1 indicates the poorest level and 10 indicates the best level of cognitive functioning.
Measured: Day 0, Day 30
Headache Impact Test-6 (HIT-6) Score
The Headache Impact Test-6 (HIT-6) scale measures the impact of headache symptoms on subject's life. Possible scores range from 36 to 78. Score of 48 or less indicates headache has little impact on life. Score of 60-78 indicative of very severe impact.
Measured: Day 0, Day 30
Migraine Specific Quality of Life Questionnaire (MSQ)
The Migraine-Specific Quality of Life Questionnaire (MSQ) is a scale that measures the impact of migraine across three aspects: role function-restrictive (RR), role function-preventive (RP), and emotional function (EF). Possible scores on each subscale range from a 0 to 100 scale such that higher scores indicate better quality of life.
Measured: Day 0, Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2010 (estimated)
- Study startMay 2010
- Primary completionNov 2012
- Study completionNov 2012
Why it stopped: Enrollment rate was slower than anticipated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Post-Traumatic HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cady, Roger, M.D.
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Roger K Cady, MD, Principal investigator, Clinvest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01053507
- Sponsor's protocol ID
- 114126
- Status last verified
- Jul 2020
- First submitted
- 19 Jan 2010
- Last updated
- 29 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 15658950Headache 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.
PubMed 14979299Cady 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Treximet for Prevention of Post Traumatic Headache Associated With Cognitive Dysfunction
- ClinicalTrials.gov ID
- NCT01053507
- Acronym / sponsor ID
- 114126
- Conditions
- Post-Traumatic Headache
- Keywords
- Headache, Post-traumatic headache, Brain injury, Cognitive impairment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment rate was slower than anticipated.
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Cady, Roger, M.D.
- Collaborators
- GlaxoSmithKline
- Study start
- May 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 21 Jan 2010 (estimated)
- Results
- Posted 10 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Subjects will be enrolled at 3 investigative sites. At Visit 1, a medical, headache, and medication history will be collected and a physical and neurological exam with vital signs will be performed. An ECG will be completed if one has not been completed in the previous 6 months. Subjects will be administered a series of psychological tests to help the study doctor decide whether or not a subject is eligible. The Headache Impact Test-6 and Migraine Specific Quality of Life Questionnaire will be completed at each visit. During a 30-day Baseline Period, subjects will treat with their usual medication and complete a daily Diary documenting headache symptoms and treatment. At Visits 2 and 3 subjects will complete the Mental Efficiency Workload Test and Migraine Early Warning Tool. Following randomization at Visit 2, subjects will treat daily for 30 days with Treximet or a matching placebo. Subjects will be provided with Treximet for rescue of any persisting or recurring headache. During the Treatment Period, subjects will complete a daily Diary reporting headache symptoms and response to treatment. After the 30-day Treatment Period, subjects will exit the study at Visit 3 .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treximet | Active comparator | Drug: sumatriptan/naproxen sodiumIn 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. |
| Placebo | Placebo comparator | Drug: PlaceboIn the 30-day Treatment Period, subjects randomized to placebo will treat with 1 tablet placebo x 30 days. Placebo matches Treximet. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (20 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sumatriptan/naproxen sodiumAlso: TreximetEach 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. | Drug | Treximet |
| PlaceboEach 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. | Drug | Placebo |
Primary outcome
Headache Days
Time frame: Day 0, Day 30
Change in number of headache days at Day 0 vs. Day 30 in Treximet arm vs. Placebo arm.
Change in Number of Associated Headache Symptoms
Time frame: Day 0, Day 30
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.
3 secondary outcomes
Mental Efficiency Workload Test (MEWT) Performance Index
Time frame: Day 0, Day 30
Headache Impact Test-6 (HIT-6) Score
Time frame: Day 0, Day 30
Migraine Specific Quality of Life Questionnaire (MSQ)
Time frame: Day 0, Day 30
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15658950Baandrup 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.
- Background: PubMed 14979299Headache 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.
- BackgroundCady 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roger K Cady, MD principal investigator
Clinvest
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sumatriptan/naproxen sodium in people with Post-Traumatic Headache, run by Cady, Roger, M.D. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache Days (time frame: Day 0, Day 30). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01053507, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2020.