Chronic Post-traumatic HeadacheMaxaltNCT01306266
Study of Rizatriptan in the Treatment of Acute Attacks of Post-traumatic Headache in U.S. Military Troops
A study testing Rizatriptan in people with Chronic Post-traumatic Headache, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 1 site in United States.
Trial summary
The purpose of the study is to determine the effectiveness of rizatriptan for treating attacks of chronic post-traumatic headache. Read more about this study
- Who is it for?
- Ages 18 to 49 years, men only
- Conditions the study is for
- Chronic Post-traumatic Headache
- What is being tested?
- Rizatriptan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Aug 2011
- Phase
- Interventional
- 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 49 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- U.S. Army soldier with history of concussion while deployed to a combat zone. Concussion is defined as head trauma with all of the following:
- No loss of consciousness or loss of consciousness less than 30 minutes.
- Glasgow Coma Score 13-15 (if known)
- Symptoms or signs of concussion.
- Concussion was secondary to primary, secondary, or tertiary blast injury.
- Headaches started within 7 days of concussion.
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- Headaches have occurred for more than 3 months but not more than 24 months since the precipitating concussion.
- Headaches occurred 3 to 14 days per month during each of the previous two months.
- Headaches are migraine type and possess three or more of the following migraine features:
- moderate or severe pain
- throbbing or pulsatile pain
- unilateral or asymmetric pain
- pain exacerbated by or interfering with routine physical activity
- nausea or vomiting
- photosensitivity and phonosensitivity
- Headaches last 4 or more hours without treatment.
- Males 18 to 49 years of age.
- Migraine Disability Assessment Score (MIDAS) greater than 10 or Headache Impact Test-6 (HIT6) score greater than 60.
- -
Who cannot join
- Patients with a history of migraine headaches prior to concussion will be excluded.
- Prior use of any triptan medication for headache.
- Use of non-opioid analgesic medications 15 or more days per month for the previous month.
- Use of opioid medications more than 10 days in the previous month.
- Alcohol consumption of more than two servings (a serving is 2 oz hard liquor, 5 oz wine, or 12 oz beer) per day or more than 3 servings at one time on a weekly basis.
- Taking two or more medications from the following medication classes: SSRI, SNRI, or TCA.
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- Headache prophylactic medication is allowed but must remain unchanged during the study period.
- Patients with depression, defined as a PHQ-9 score greater than 15, will be excluded from study participation.
- PTSD is NOT an exclusion criterion. PTSD will be defined as a clinical diagnosis by a behavioral health provider or PTSD symptom checklist score of 50 or higher.
- Systolic BP > 140 or diastolic BP > 90 on repeated measurements.
- Active use of dihydroergotamine.
- Known coronary artery disease, prior myocardial infarction, history of stroke or TIA, or liver disease.
- Subjects who will not be available for study-related follow-up visits will be excluded.
- Patient has cognitive impairment defined as mini-mental status exam score less than 27.
- Patients undergoing a medical board for headache, sequelae of TBI, or psychiatric disorders will be excluded.
- Patients suspected of malingering, exaggerating symptoms, or non-compliance will be excluded from study participation.
- Patient has hemiplegic migraine or basilar migraine.
Trial locations and contacts
1 site in 1 country.
United States1 site
Madigan Army Medical Center - Neurology Clinic
Tacoma, Washington, 98431
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Crossover Trial of Rizatriptan 10 mg Oral Disintegrating Tablet for Treatment of Acute Attacks of Chronic, Blast-induced, Post-traumatic Headache in U.S. Military Troops
The purpose of the study is to determine the effectiveness of rizatriptan for treating attacks of chronic post-traumatic headache.
Read the detailed description
Chronic post-traumatic headaches develop in about one third of soliders who have had head trauma caused by a blast. A wide variety of pain medicines, including rizatriptan, are used to treat these headaches in clinical practice. However, the effectiveness has not been established by clinical research studies.
- Conditions
- Chronic Post-traumatic Headache
- Being tested
- Rizatriptan, Placebo
- Keywords
- active duty, blast induced, headache
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RizatriptanDrug
Also called Maxalt
initial treatment with Maxalt-MLT 10 mg followed by treatment with placebo. Drug is to be taken at onset of a moderate or severe headache
PlaceboDrug
Also called sugar pill
Initial treatment with placebo followed by treatment with Maxalt-MLT 10 mg at onset of a moderate or severe headache.
| Study group | Role | What they receive |
|---|---|---|
| rizatriptan | Active comparator | initial treatment with Maxalt-MLT 10 mg followed by treatment with placebo Receives: Drug: Rizatriptan |
| Placebo | Placebo comparator | Initial treatment with placebo followed by treatment with Maxalt-MLT 10 mg Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache Severity
proportion of subjects who obtain headache relief defined as no pain or mild pain two hours after dosing
Measured: 2 hours
Secondary outcomes (1)
24 hour Migraine Quality of Life score
proportions of subjects achieving complete headache relief at 2 hours, sustained headache relief at 24 hours, 24-hour Migraine Quality of Life score, disability 2 hours after dosing, occurrence of associated symptoms, and side effects.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2011 (estimated)
- Study startFeb 2011
- Primary completionAug 2011
- Study completionAug 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Marianne Spevak, Henry M. Jackson Foundation for the Advancement of Military Medicine
- Investigators
- Jay C Erickson, MD, Principal investigator, U.S. Army Medical Corp. Madigan Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01306266
- Sponsor's protocol ID
- MAMC 211004
- Acronym
- Maxalt
- Status last verified
- Aug 2015
- First submitted
- 25 Feb 2011
- Last updated
- 18 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Crossover Trial of Rizatriptan 10 mg Oral Disintegrating Tablet for Treatment of Acute Attacks of Chronic, Blast-induced, Post-traumatic Headache in U.S. Military Troops
- ClinicalTrials.gov ID
- NCT01306266
- Acronym / sponsor ID
- Maxalt / MAMC 211004
- Conditions
- Chronic Post-traumatic Headache
- Keywords
- active duty, blast induced, headache
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military MedicineUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Feb 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (estimated)
- First posted
- 1 Mar 2011 (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.
The purpose of the study is to determine the effectiveness of rizatriptan for treating attacks of chronic post-traumatic headache.
Detailed description
Chronic post-traumatic headaches develop in about one third of soliders who have had head trauma caused by a blast. A wide variety of pain medicines, including rizatriptan, are used to treat these headaches in clinical practice. However, the effectiveness has not been established by clinical research studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rizatriptan | Active comparator | Drug: Rizatriptaninitial treatment with Maxalt-MLT 10 mg followed by treatment with placebo |
| Placebo | Placebo comparator | Drug: PlaceboInitial treatment with placebo followed by treatment with Maxalt-MLT 10 mg |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- U.S. Army soldier with history of concussion while deployed to a combat zone. Concussion is defined as head trauma with all of the following:
- No loss of consciousness or loss of consciousness less than 30 minutes.
- Glasgow Coma Score 13-15 (if known)
- Symptoms or signs of concussion.
- Concussion was secondary to primary, secondary, or tertiary blast injury.
Key exclusion criteria (17 listed)
- Patients with a history of migraine headaches prior to concussion will be excluded.
- Prior use of any triptan medication for headache.
- Use of non-opioid analgesic medications 15 or more days per month for the previous month.
- Use of opioid medications more than 10 days in the previous month.
- Alcohol consumption of more than two servings (a serving is 2 oz hard liquor, 5 oz wine, or 12 oz beer) per day or more than 3 servings at one time on a weekly basis.
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 |
|---|---|---|
| RizatriptanAlso: Maxaltinitial treatment with Maxalt-MLT 10 mg followed by treatment with placebo. Drug is to be taken at onset of a moderate or severe headache | Drug | rizatriptan |
| PlaceboAlso: sugar pillInitial treatment with placebo followed by treatment with Maxalt-MLT 10 mg at onset of a moderate or severe headache. | Drug | Placebo |
Primary outcome
Headache Severity
Time frame: 2 hours
proportion of subjects who obtain headache relief defined as no pain or mild pain two hours after dosing
1 secondary outcome
24 hour Migraine Quality of Life score
Time frame: 24 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2015.
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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 C Erickson, MD principal investigator
U.S. Army Medical Corp. 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 study testing Rizatriptan in people with Chronic Post-traumatic Headache, run by Henry M. Jackson Foundation for the Advancement of Military Medicine 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 19 inclusion and 17 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: withdrawn, as of the sponsor's last update on 18 Aug 2015. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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 Severity (time frame: 2 hours). 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 18 Aug 2015.