Migraine DisordersPhase 2NCT00319137
An Adaptive Design Trial Of GW274150 In The Treatment Of Acute Migraine
A Phase 2 study testing GW274150 in people with Migraine Disorders and Migraine, run by GlaxoSmithKline at 5 sites in 2 countries.
Trial summary
Nitric oxide (NO) is likely to be involved in the development of migraine headache. Nitric oxide synthase (NOS) is an important chemical involved in the production of NO. Reduction of NOS, and therefore NO, may be an effective technique for the treatment of migraine headache. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine Disorders, Migraine
- What is being tested?
- GW274150
- How many people
- 126 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Dec 2005to not given
- Phase
- Phase 2
- 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
- Suffering from migraine with or without aura.
- Migraine for at least one year, and the age of onset was prior to 50 years.
- Consistent migraine headache over time and has had at least 1 migraine headache attacks but less than 15 days with headache (migraine or non-migraine) per month in each of the three months prior to the Screening Visit and maintains this requirement during the baseline period.
- Able to distinguish migraine headache attacks as discreet attacks from other headaches (i.e. tension-type headaches).
- Typically have moderate to severe migraine pain preceded by an identifiable mild pain phase.
- No clinically significant abnormality identified on the medical or laboratory evaluation. A subject with a clinical abnormality or laboratory parameters outside the reference range may be included only if the doctor considers that the finding will not introduce additional risk factors and will not interfere with the study procedures.
- Written informed consent prior to entry into the study.
- Females who are: a) non-childbearing potential or, b) of child-bearing potential, has a negative pregnancy test at screen, and is taken adequate contraceptive measures.
Who cannot join
- As a result of the medical interview, physical examination or screening investigations, that the doctor considers the subject unfit for the study.
- History of alcohol, substance or drug abuse within the last year.
- Taken a migraine prophylactic medication within 1 month of the Screening Visit.
- Uses an opiate as first line acute treatment for migraine attacks.
- History of ergotamine, triptan, opioid, or combination medication intake on greater than/equal 10 days per month on a regular basis for greater than/equal 3 months.
- History of simple analgesic intake on greater than/equal 15 days per month for greater than/equal 3 months.
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- Do not receive migraine relief from a triptan migraine treatment.
- Uncontrolled hypertension at the Screening Visit, defined as systolic blood pressure >140mmHg or diastolic blood pressure >90mmHg.
- Evidence of renal impairment - calculated creatinine clearance <60ml/min or clinically relevant finding on urinalysis.
- History of drug or other allergy which, in the opinion of the doctor, makes the subject unsuitable for participation in the study.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
New Zealand4 sites
GSK Investigational Site
Auckland, 1311
GSK Investigational Site
Christchurch, 8001
GSK Investigational Site
Hamilton, 2001
GSK Investigational Site
Wellington, 6035
About this study
Official title: A Randomized, Single-Blind, Single-Attack, Placebo-Controlled, Adaptive Design Study to Assess the Safety and Efficacy of Doses of 5-180 mg of the iNOS Inhibitor GW274150 in the Treatment of Acute Migraine During the Mild Headache Phase
Nitric oxide (NO) is likely to be involved in the development of migraine headache. Nitric oxide synthase (NOS) is an important chemical involved in the production of NO. Reduction of NOS, and therefore NO, may be an effective technique for the treatment of migraine headache. GW274150 is a highly selective inhibitor of NOS and offers the potential of anti-inflammatory activity in migraine through a novel mechanism of action. The intent of this study is to investigate the safety and efficacy of GW274150 for the acute treatment of migraine headache.
- Conditions
- Migraine Disorders, Migraine
- Being tested
- GW274150
- Keywords
- GW274150, Nitric Oxide, acute migraine
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW274150Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose of GW274150 that results in 50% of subjects reporting cessation of migraine pain by 2 hours and to study the relationship between dose and therapeutic response.
Secondary outcomes (1)
Adverse events following treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2006 (estimated)
- Study startDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine DisordersStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 126 participants
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00319137
- Sponsor's protocol ID
- NOS102512
- Status last verified
- Feb 2011
- First submitted
- 26 Apr 2006
- Last updated
- 4 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-Blind, Single-Attack, Placebo-Controlled, Adaptive Design Study to Assess the Safety and Efficacy of Doses of 5-180 mg of the iNOS Inhibitor GW274150 in the Treatment of Acute Migraine During the Mild Headache Phase
- ClinicalTrials.gov ID
- NCT00319137
- Acronym / sponsor ID
- NOS102512
- Conditions
- Migraine Disorders, Migraine
- Keywords
- GW274150, Nitric Oxide, acute migraine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- First posted
- 27 Apr 2006 (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.
Nitric oxide (NO) is likely to be involved in the development of migraine headache. Nitric oxide synthase (NOS) is an important chemical involved in the production of NO. Reduction of NOS, and therefore NO, may be an effective technique for the treatment of migraine headache. GW274150 is a highly selective inhibitor of NOS and offers the potential of anti-inflammatory activity in migraine through a novel mechanism of action. The intent of this study is to investigate the safety and efficacy of GW274150 for the acute treatment of migraine headache.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Suffering from migraine with or without aura.
- Migraine for at least one year, and the age of onset was prior to 50 years.
- Consistent migraine headache over time and has had at least 1 migraine headache attacks but less than 15 days with headache (migraine or non-migraine) per month in each of the three months prior to the Screening Visit and maintains this requirement during the baseline period.
- Able to distinguish migraine headache attacks as discreet attacks from other headaches (i.e. tension-type headaches).
- Typically have moderate to severe migraine pain preceded by an identifiable mild pain phase.
Key exclusion criteria (10 listed)
- As a result of the medical interview, physical examination or screening investigations, that the doctor considers the subject unfit for the study.
- History of alcohol, substance or drug abuse within the last year.
- Taken a migraine prophylactic medication within 1 month of the Screening Visit.
- Uses an opiate as first line acute treatment for migraine attacks.
- History of ergotamine, triptan, opioid, or combination medication intake on greater than/equal 10 days per month on a regular basis for greater than/equal 3 months.
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 |
|---|---|---|
| GW274150 | Drug | – |
Primary outcome
Dose of GW274150 that results in 50% of subjects reporting cessation of migraine pain by 2 hours and to study the relationship between dose and therapeutic response.
1 secondary outcome
Adverse events following treatment
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 4 Jun 2012.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GW274150 in people with Migraine Disorders and Migraine, run by GlaxoSmithKline at 5 sites in 2 countries.
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: finished, as of the sponsor's last update on 4 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in New Zealand, Australia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Dose of GW274150 that results in 50% of subjects reporting cessation of migraine pain by 2 hours and to study the relationship between dose and therapeutic response.. 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 4 Jun 2012.