Migraine HeadachesPhase 3NCT00442221
The Safety Of Combo Formulation In The Treatment Of Multiple Episodes Of Acute Migraine Over 12 Months
A Phase 3 study testing Sumatriptan and Naproxen sodium in people with Migraine Headaches, run by POZEN at 2 sites in United States.
Trial summary
The objective of this study is to assess the safety of a single-tablet dose of Combo Formulation for the treatment of moderate to severe migraines Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine Headaches
- What is being tested?
- Sumatriptan and Naproxen sodium
- How many people
- 500 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2004to Aug 2004
- Phase
- Phase 3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is a male or a female who is not pregnant or is not lactating. A female is eligible to enter and participate in this study if she is of:
- Non-childbearing potential (i.e., physiologically incapable of becoming pregnant); or,
- Child-bearing potential, has a negative pregnancy test (urine or serum) at screen, and employs one of the following acceptable measures of contraception:
- Complete abstinence from intercourse from 2 weeks prior to administration of the investigational product, throughout the study, and for a time interval after completion or premature discontinuation from the study to account for elimination of the investigational drug (a minimum of 24 hrs); 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 in the preceding 2 weeks when they present to the clinic for randomized treatment; or,
- Female sterilization; or,
- Sterilization of male partner; or,
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- Implants of levonorgestrel; or,
- Injectable progestogen; or,
- Oral contraceptive (combined or progestogen only); or,
- Any intrauterine device (IUD) with published data showing that the lowest expected failure rate is less than 1% per year (not all IUDs meet this criterion); or,
- Any other method with published data showing that the lowest expected failure rate for that method is less than 1% per year.
- Barrier method only if used in combination with any of the above acceptable methods
- Subject is 18 - 65 years of age.
- Subject's first migraine occurred prior to the age of 50 years.
- Subject has at least a 6-month history, immediately prior to screening, of migraine with or without aura according to the International Headache Society criteria (see Appendix I).
- Subject experienced an average migraine headache frequency of 2-6 moderate or severe attacks per month in the previous 6 months.
- Subject is able to distinguish his/her migraine attacks as discrete from any other types of headaches.
- Subject is willing and able to give written informed consent prior to entry into the study.
Who cannot join
- Subject has received another investigational drug within the 4 weeks preceding this study, or subject was enrolled in this study previously.
- Subject has any concurrent medical or psychiatric condition that may affect the interpretation of efficacy and/or safety data or which otherwise contraindicates participation in a clinical trial with a new chemical entity. This includes, but is not limited to, chronic unstable debilitating diseases such as HIV infection, multiple sclerosis, cancer, etc.
- Subject has a clinically significant disorder that, in the opinion of the investigator, would result in the subject's inability to understand and comply with the requirements of the study.
- Subject has a history, symptoms, or signs of ischemic cardiac, cerebrovascular or peripheral vascular syndromes or other significant underlying cardiovascular diseases.
- Subject has a history of cardiac arrhythmias requiring medication or a history of a clinically significant electrocardiogram (ECG) abnormality that, in the investigator's opinion, contraindicates participation in this study.
- Subject has a history of cerebrovascular abnormalities including stroke and/or transient ischemic attacks.
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- Subject who, in the investigator's opinion, is likely to have unrecognized cardiovascular disease, based on history or the presence of risk factors (e.g. hypertension, hypercholesterolemia, smoker, obesity, diabetes, strong family history of coronary artery disease, female with surgical or physiological menopause, or male over 40 years of age).
- Subject has evidence or history of ischemic abdominal syndromes, peripheral vascular disease or Raynaud syndrome.
- Subject has uncontrolled hypertension at screening (sitting systolic pressure >160 millimeters of mercury (mmHg), diastolic pressure >95 mmHg).
- Subject has a history of epilepsy or conditions associated with a lowered seizure threshold.
- Subject has a history of basilar or hemiplegic migraine.
- Subject has a history of impaired hepatic or renal function that, in the investigator's opinion, contraindicates participation in this study; or the subject has any other abnormal laboratory value of clinical significance for this study.
- Subject has a history of non-migraine (i.e., tension-type, sinus, etc.) headache frequency greater than or equal to 15 days/month in each of the 3 months prior to screening.
- Subject has had >6 migraine attacks/month in either of the 2 months prior to screening.
- Subject is currently taking a monoamine oxidase inhibitor (MAOI), has taken a MAOI within the 2 weeks prior to screening, or plans to take a MAOI within 2 weeks after treatment.
- Subject is currently taking any anti-coagulant (e.g., warfarin) or NSAID (except doses of aspirin ≤325 mg per day being used for cardiovascular prophylaxis) on a regular basis.
- Subject is currently taking, or has taken in the previous 3 months, a migraine prophylactic medication containing ergotamine, an ergot derivative (dihydroergotamine), or methysergide.
- Subject is currently taking, or has taken in the previous 4 weeks, herbal preparations containing St. John's Wort (Hypericum perforatum)
- Subject has hypersensitivity, intolerance, or contraindication to the use of sumatriptan or naproxen sodium, any of its components, or any other 5-HT1 receptor agonist.
- Subject has a history of allergic reactions to naproxen preparations, including subject in whom aspirin or other NSAID drugs induce the syndrome of asthma, rhinitis, and nasal polyps.
- Subject is pregnant, actively trying to become pregnant, or breast-feeding.
- Subject is of childbearing potential and not using adequate contraceptive measures.
- Subject has a recent history (in the past 3 months) suggestive of alcohol or drug abuse or dependence, including the overuse (abuse) of ergotamines and/or narcotics to treat migraines. Ergotamine abuse is daily use for 14 consecutive days or intermittent consumption exceeding 10 mg per week for any two weeks.
- Subject has participated in an investigational drug trial within the previous four weeks, or plans to participate in another study at any time during the period of this study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
POZEN Inc.
Chapel Hill, North Carolina, 27517
Headache Wellness Center
Greensboro, North Carolina, 27401
About this study
Official title: An Open-Label, Repeat Dose Study Of The Safety Of Combo Formulation In The Treatment Of Multiple Episodes Of Acute Migraine Over 12 Months
The objective of this study is to assess the safety of a single-tablet dose of Combo Formulation for the treatment of moderate to severe migraines
Read the detailed description
The objective of this study is to assess the safety of a single-tablet dose of Combo Formulation for the treatment of moderate to severe migraines, with an optional second dose at least 2 hours following the first dose, if needed. Combo Formulation will be administered on average at least twice per month for 12 months.
- Conditions
- Migraine Headaches
- Being tested
- Sumatriptan and Naproxen sodium
- Keywords
- Migrane headaches
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sumatriptan and Naproxen sodiumDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
END POINTS
Adverse events, physical examination findings, vital signs and clinical laboratory findings will be evaluated.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2007 (estimated)
- Study startMay 2004
- Study completionAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine HeadachesStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants
Sponsor and investigators
- Lead sponsor
- POZEN
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- David Taylor, Study director, POZEN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00442221
- Sponsor's protocol ID
- MT400-303
- Status last verified
- Feb 2007
- First submitted
- 28 Feb 2007
- Last updated
- 1 Mar 2007
- Results posted
- No
- Data monitoring committee
- Yes
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Repeat Dose Study Of The Safety Of Combo Formulation In The Treatment Of Multiple Episodes Of Acute Migraine Over 12 Months
- ClinicalTrials.gov ID
- NCT00442221
- Acronym / sponsor ID
- MT400-303
- Conditions
- Migraine Headaches
- Keywords
- Migrane headaches
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants
- Lead sponsor
- POZENIndustry (pharma, biotech, devices)
- Study start
- May 2004
- Study completion
- Aug 2004
- First posted
- 1 Mar 2007 (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 objective of this study is to assess the safety of a single-tablet dose of Combo Formulation for the treatment of moderate to severe migraines
Detailed description
The objective of this study is to assess the safety of a single-tablet dose of Combo Formulation for the treatment of moderate to severe migraines, with an optional second dose at least 2 hours following the first dose, if needed. Combo Formulation will be administered on average at least twice per month for 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Subject is a male or a female who is not pregnant or is not lactating. A female is eligible to enter and participate in this study if she is of:
- Subject is 18 - 65 years of age.
- Subject's first migraine occurred prior to the age of 50 years.
- Subject has at least a 6-month history, immediately prior to screening, of migraine with or without aura according to the International Headache Society criteria (see Appendix I).
- Subject experienced an average migraine headache frequency of 2-6 moderate or severe attacks per month in the previous 6 months.
Key exclusion criteria (24 listed)
- Subject has received another investigational drug within the 4 weeks preceding this study, or subject was enrolled in this study previously.
- Subject has any concurrent medical or psychiatric condition that may affect the interpretation of efficacy and/or safety data or which otherwise contraindicates participation in a clinical trial with a new chemical entity. This includes, but is not limited to, chronic unstable debilitating diseases such as HIV infection, multiple sclerosis, cancer, etc.
- Subject has a clinically significant disorder that, in the opinion of the investigator, would result in the subject's inability to understand and comply with the requirements of the study.
- Subject has a history, symptoms, or signs of ischemic cardiac, cerebrovascular or peripheral vascular syndromes or other significant underlying cardiovascular diseases.
- Subject has a history of cardiac arrhythmias requiring medication or a history of a clinically significant electrocardiogram (ECG) abnormality that, in the investigator's opinion, contraindicates participation in this study.
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 and Naproxen sodium | Drug | – |
Primary outcome
END POINTS
Adverse events, physical examination findings, vital signs and clinical laboratory findings will be evaluated.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2007.
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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.
David Taylor study director
POZEN
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sumatriptan and Naproxen sodium in people with Migraine Headaches, run by POZEN at 2 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 18 inclusion and 24 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: finished, as of the sponsor's last update on 1 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
END POINTS. 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?
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 1 Mar 2007.