HeadachePhase 4NCT00862095
Medical Therapies for Chronic Post-Traumatic Headaches
A Phase 4 study testing Propranolol, Amitriptyline and Topiramate in people with Headache, run by Madigan Army Medical Center at 1 site in United States.
Trial summary
To determine if propranolol, amitriptyline, or topiramate decreases headache frequency in patients with chronic post-traumatic headaches. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Headache
- What is being tested?
- Propranolol, Amitriptyline and Topiramate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Apr 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient meets ICHD criteria for chronic post-traumatic headaches (see below).
- Patient is 18-50 years old.
- Patient has experienced 6 or more days of headache per month for each of the last 2 months.
- Patient has full capacity to provide informed consent.
- Patient will be available for all study-related visits over the next 4 months.
- Patient must be eligible to receive care at Madigan Army Medical Center
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- International Classification of Headache Disorders (version 2) diagnostic criteria for chronic post-traumatic headaches attributed to mild head injury:
- Headaches beginning within 1 week of mild traumatic head injury.
- Headaches persisting > 3 months after head trauma.
- Head trauma with all of the following:
- no loss of consciousness or loss of consciousness < 30 minutes
- Glasgow Coma Score (GCS) 13-15
- symptoms or signs diagnostic of concussion
Who cannot join
- Patient has another headache disorder not attributable to head trauma which accounts for at least half of the patient's headache episodes.
- Patient is currently taking propranolol, amitriptyline, or topiramate for any reason.
- Patient previously tried propranolol, amitriptyline, or topiramate for headache treatment.
- Patient started a new treatment for headache prevention within the last 6 weeks. Prophylactic treatments initiated prior to 6 weeks ago are allowed as long as the dose or regimen is stable. Medications for aborting acute headaches are also allowed.
- Patient previously tried more than two medications for headache prevention.
- Patient is using narcotic analgesics on average more than 10 days a month.
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- Patient has a medical condition or is taking a medication that is considered a contraindication for propranolol, topiramate, or amitriptyline. Medical conditions include liver disease, renal impairment, cardiac dysrhythmias, untreated thyroid disease, orthostatic hypotension, asthma requiring treatment with inhalers, glaucoma, kidney stones, insulin-requiring diabetes, or pregnancy.
- Patient has known hepatic, renal, or cardiac disorders.
- Patient drinks on average more than two servings of alcohol (2 oz hard liquor, 5 oz wine, 12 oz beer) per day or more than 3 servings at one time on a weekly basis.
- Patient has abnormalities on baseline EKG.
- Patient has major depression defined as a score >15 on the Patient Health Questionnaire-9.
- Patient is pregnant, planning to become pregnant in the next year, or is a female of reproductive potential who is not using a reliable form of birth control.
- Patient has cognitive impairment defined as mini-mental status exam score <27.
- SBP < 90, HR < 50, or HR > 100.
Trial locations and contacts
1 site in 1 country.
United States1 site
Madigan Army Medical Center
Tacoma, Washington, 98431
About this study
Official title: A Randomized Controlled Trial of Medical Therapies for Chronic Post-Traumatic Headaches
To determine if propranolol, amitriptyline, or topiramate decreases headache frequency in patients with chronic post-traumatic headaches.
Read the detailed description
A total of 240 patients meeting International Classification of Headache Disorders (ICHD) diagnostic criteria for chronic post-traumatic headaches will be enrolled. Subjects will be recruited from the Neurology Clinic at Madigan Army Medical Center. Study participants will be U.S. Army soldiers who sustained a mild traumatic head injury while deployed to a combat theater resulting in chronic post-traumatic headaches. Subjects will be randomized to placebo, propranolol (target dose 80 mg a day), amitriptyline (target dose 50 mg a day), or topiramate (target dose 100 mg a day) for 3 months.
The primary outcome measure will be the mean number of headache days per month on the third month of treatment. Secondary outcome measures will include the proportion of subjects with at least a 25% reduction in headache frequency, headache severity (0-10 scale), headache duration (hours), headache-related disability (measured by the Headache Impact Test and Migraine Disability Assessment Scale), PTSD symptom checklist score, and medication side effects and tolerability.
- Conditions
- Headache
- Being tested
- Placebo, Propranolol, Amitriptyline, Topiramate
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Every month for 3 months
PropranololDrug
Also called Inderal
target does 80 mg per day for 3 months
AmitriptylineDrug
Also called Elavil
Target does of 50 mg per day for 3 months
TopiramateDrug
Also called Topamax
Target dose 100 mg a day for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo group Receives: Drug: Placebo |
| Propranolol | Experimental | Propranolol (target dose 80 mg a day) Receives: Drug: Propranolol |
| Topiramate | Experimental | Topiramate (target dose 100 mg a day) Receives: Drug: Topiramate |
| Amitriptyline | Experimental | Amitriptyline (target dose 50 mg a day) Receives: Drug: Amitriptyline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache days per month on the third month of treatment
Measured: Monthly for 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2009 (estimated)
- Study startJun 2008
- Primary completionApr 2013
- Study completionApr 2013
Why it stopped: inadequate enrollment, insufficient funds to continue enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Madigan Army Medical Center
- Sponsor type
- US federal agency
- Collaborators
- U.S. Army Medical Research and Development Command
- Responsible party
- Principal investigator, Jay C. Erickson, Madigan Army Medical Center
- Investigators
- Jay Erickson, MD, Principal investigator, Madigan Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00862095
- Sponsor's protocol ID
- 208075
- Status last verified
- Apr 2013
- First submitted
- 12 Mar 2009
- Last updated
- 23 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Medical Therapies for Chronic Post-Traumatic Headaches
- ClinicalTrials.gov ID
- NCT00862095
- Acronym / sponsor ID
- 208075
- Conditions
- Headache
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: inadequate enrollment, insufficient funds to continue enrollment
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Madigan Army Medical CenterUS federal agency
- Collaborators
- U.S. Army Medical Research and Development Command
- Study start
- Jun 2008
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 16 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine if propranolol, amitriptyline, or topiramate decreases headache frequency in patients with chronic post-traumatic headaches.
Detailed description
A total of 240 patients meeting International Classification of Headache Disorders (ICHD) diagnostic criteria for chronic post-traumatic headaches will be enrolled. Subjects will be recruited from the Neurology Clinic at Madigan Army Medical Center. Study participants will be U.S. Army soldiers who sustained a mild traumatic head injury while deployed to a combat theater resulting in chronic post-traumatic headaches. Subjects will be randomized to placebo, propranolol (target dose 80 mg a day), amitriptyline (target dose 50 mg a day), or topiramate (target dose 100 mg a day) for 3 months.
The primary outcome measure will be the mean number of headache days per month on the third month of treatment. Secondary outcome measures will include the proportion of subjects with at least a 25% reduction in headache frequency, headache severity (0-10 scale), headache duration (hours), headache-related disability (measured by the Headache Impact Test and Migraine Disability Assessment Scale), PTSD symptom checklist score, and medication side effects and tolerability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo group |
| Propranolol | Experimental | Drug: PropranololPropranolol (target dose 80 mg a day) |
| Topiramate | Experimental | Drug: TopiramateTopiramate (target dose 100 mg a day) |
| Amitriptyline | Experimental | Drug: AmitriptylineAmitriptyline (target dose 50 mg a day) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Patient meets ICHD criteria for chronic post-traumatic headaches (see below).
- Patient is 18-50 years old.
- Patient has experienced 6 or more days of headache per month for each of the last 2 months.
- Patient has full capacity to provide informed consent.
- Patient will be available for all study-related visits over the next 4 months.
Key exclusion criteria (14 listed)
- Patient has another headache disorder not attributable to head trauma which accounts for at least half of the patient's headache episodes.
- Patient is currently taking propranolol, amitriptyline, or topiramate for any reason.
- Patient previously tried propranolol, amitriptyline, or topiramate for headache treatment.
- Patient started a new treatment for headache prevention within the last 6 weeks. Prophylactic treatments initiated prior to 6 weeks ago are allowed as long as the dose or regimen is stable. Medications for aborting acute headaches are also allowed.
- Patient previously tried more than two medications for headache prevention.
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 |
|---|---|---|
| PlaceboEvery month for 3 months | Drug | Placebo |
| PropranololAlso: Inderaltarget does 80 mg per day for 3 months | Drug | Propranolol |
| AmitriptylineAlso: ElavilTarget does of 50 mg per day for 3 months | Drug | Amitriptyline |
| TopiramateAlso: TopamaxTarget dose 100 mg a day for 3 months | Drug | Topiramate |
Primary outcome
Headache days per month on the third month of treatment
Time frame: Monthly for 4 weeks
Results and safety
The study was stopped early (reason given: inadequate enrollment, insufficient funds to continue enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2013.
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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.
Jay Erickson, MD principal investigator
Madigan Army Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propranolol, Amitriptyline and Topiramate in people with Headache, run by Madigan Army Medical Center at 1 site 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 13 inclusion and 14 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 23 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early (reason given: inadequate enrollment, insufficient funds to continue enrollment). Results are not available in the source record.
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 per month on the third month of treatment (time frame: Monthly for 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Apr 2013.