Migraine With AuraNCT00893594
Efficacy of Sumatriptan With Naprosyn in Migraine With Aura
A study testing sumatriptan with naprosyn in people with Migraine With Aura, run by Dent Neurologic Institute at 1 site in United States.
Trial summary
This is a double-blinded placebo study, examining the efficacy of Sumatriptan with Naprosyn in the treatment of migraine with aura. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine With Aura
- What is being tested?
- sumatriptan with naprosyn
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Dec 2015
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must be 18 to 50 years of age, inclusive.
- Patients will meet the International Headache Society (IHS) classification criteria for migraine with aura.
- Subjects must carry the diagnosis of 1-2 migraine with aura per month for at least three months before study inclusion. and migraine with aura were included in the study
- Subjects must have an onset of a visual aura that occurs 15-30 minutes before a migraine headache.
- Subjects must be able to understand and complete a migraine diary.
- Subjects must be able to distinguish a migraine with aura from other types of headache.
- Subjects must be in generally good health as confirmed by medical and medication history, baseline physical and neurological exam and vital signs.
- Female subjects must be either a) postmenopausal for one year, b)surgically sterile, c) practicing acceptable birth control for at least one month prior to screening and throughout study, or d) practicing abstinence and agree to continue same throughout study.
Who cannot join
- Subjects who have a significant systemic disease other than migraine that is equally painful or more painful.
- Subjects who have other progressive neurological disorders.
- Subjects who have more than 8 migraines or 15 headache days per month.
- Subjects who have previously taken Treximet and failed due to lack of efficacy or adverse side effects.
- Subjects who carry the diagnosis of chronic tension type headache or cluster headache based on the International Headache Society criteria.
- Subject should not have received any other investigative drug within 3 months prior to enrollment in the study.
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- Subject who have the diagnosis of seizure disorder, chronic daily headache, uncontrolled hypertension, cardiovascular disease, history of stroke, basilar or hemiplegic migraine, hepatic disease, or active peptic ulcer disease.
- Subjects currently taking or in 3 months prior to study, use of prophylactic migraine medications.
- Subjects who have a known allergy to Sumatriptan or Naprosyn.
- Subjects who in the opinion of Dr. Mechtler have a condition for which they should not be enrolled in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Dent Neurologic Institute
Amherst, New York, 14226
Rebecca M Hogan, BS, 716-558-5670, rhogan@dentinstitute.com
Mary K Betz, P.A., 716-558-5662, mbetz@dentinstitute.com
About this study
Official title: A Parallel Two Arm, Double Blinded Placebo Study, Examining the Efficacy of Sumatriptan With Naprosyn in the Treatment of Migraine With Aura
This is a double-blinded placebo study, examining the efficacy of Sumatriptan with Naprosyn in the treatment of migraine with aura.
- Conditions
- Migraine With Aura
- Being tested
- sumatriptan with naprosyn, placebo
- Keywords
- migraine, migraine with aura, headache
- Medical subject headings
- Migraine with Aura, Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sumatriptan with naprosynDrug
Also called Treximet
Subjects will be randomized before treatment. Subjects will take one sumatriptan 85mg/naprosyn 500mg tablets (Treximet) or placebo at onset of a migraine aura. Dose to be repeated at 2 hours if no effect in preventing onset of migraine pain.
placeboDrug
Subjects will be randomized before treatment. Subjects will take one sumatriptan 85mg/naprosyn 500mg tablets (Treximet) or placebo at onset of a migraine aura. Dose to be repeated at 2 hours if no effect in preventing onset of migraine pain.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Placebo taken at onset of aura associated with migraine. Receives: Drug: placebo |
| 2 | Active comparator | Sumatriptan with naprosyn taken at onset of aura associated with migraine. Receives: Drug: sumatriptan with naprosyn |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome measure will be comparative percentage of patients pain free at 2 and 4 hours from initiating treatment with placebo vs treatment with Treximet (sumatriptan with naprosyn).
Measured: 2 and 4 hours
Secondary outcomes (1)
Secondary outcomes will be percentage of patients with pain relief at 2 and 4 hours.
Measured: 2 and 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2009 (estimated)
- Study startOct 2010
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine With AuraStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dent Neurologic Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary Kay Betz, MS RPA-C, Dent Neurologic Institute
- Investigators
- Laszlo L Mechtler, MD, Principal investigator, Dent Neurologic Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00893594
- Sponsor's protocol ID
- 113010
- Status last verified
- Feb 2015
- First submitted
- 4 May 2009
- Last updated
- 19 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Parallel Two Arm, Double Blinded Placebo Study, Examining the Efficacy of Sumatriptan With Naprosyn in the Treatment of Migraine With Aura
- ClinicalTrials.gov ID
- NCT00893594
- Acronym / sponsor ID
- 113010
- Conditions
- Migraine With Aura
- Keywords
- migraine, migraine with aura, headache
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Dent Neurologic InstituteUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 6 May 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.
This is a double-blinded placebo study, examining the efficacy of Sumatriptan with Naprosyn in the treatment of migraine with aura.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: placeboPlacebo taken at onset of aura associated with migraine. |
| 2 | Active comparator | Drug: sumatriptan with naprosynSumatriptan with naprosyn taken at onset of aura associated with migraine. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Subjects must be 18 to 50 years of age, inclusive.
- Patients will meet the International Headache Society (IHS) classification criteria for migraine with aura.
- Subjects must carry the diagnosis of 1-2 migraine with aura per month for at least three months before study inclusion. and migraine with aura were included in the study
- Subjects must have an onset of a visual aura that occurs 15-30 minutes before a migraine headache.
- Subjects must be able to understand and complete a migraine diary.
Key exclusion criteria (10 listed)
- Subjects who have a significant systemic disease other than migraine that is equally painful or more painful.
- Subjects who have other progressive neurological disorders.
- Subjects who have more than 8 migraines or 15 headache days per month.
- Subjects who have previously taken Treximet and failed due to lack of efficacy or adverse side effects.
- Subjects who carry the diagnosis of chronic tension type headache or cluster headache based on the International Headache Society criteria.
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 with naprosynAlso: TreximetSubjects will be randomized before treatment. Subjects will take one sumatriptan 85mg/naprosyn 500mg tablets (Treximet) or placebo at onset of a migraine aura. Dose to be repeated at 2 hours if no effect in preventing onset of migraine pain. | Drug | 2 |
| placeboSubjects will be randomized before treatment. Subjects will take one sumatriptan 85mg/naprosyn 500mg tablets (Treximet) or placebo at onset of a migraine aura. Dose to be repeated at 2 hours if no effect in preventing onset of migraine pain. | Drug | 1 |
Primary outcome
Primary outcome measure will be comparative percentage of patients pain free at 2 and 4 hours from initiating treatment with placebo vs treatment with Treximet (sumatriptan with naprosyn).
Time frame: 2 and 4 hours
1 secondary outcome
Secondary outcomes will be percentage of patients with pain relief at 2 and 4 hours.
Time frame: 2 and 4 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 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.
Laszlo L Mechtler, MD principal investigator
Dent Neurologic Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sumatriptan with naprosyn in people with Migraine With Aura, run by Dent Neurologic Institute 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 8 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 19 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mary K Betz, MS (716-250-2000, mbetz@dentinstitute.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome measure will be comparative percentage of patients pain free at 2 and 4 hours from initiating treatment with placebo vs treatment with Treximet (sumatriptan with naprosyn). (time frame: 2 and 4 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 19 Feb 2015.