Migraine DisordersPhase 2NCT00242866
Use Of GW274150 In The Prophylactic Treatment Of Migraine
A Phase 2 study testing GW274150 in people with Migraine Disorders, run by GlaxoSmithKline at 62 sites in 9 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 prevention of migraine headache. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Migraine Disorders
- What is being tested?
- GW274150
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 430 participants
- Where
- 62 sitesin 9 countries
- Study dates
- Oct 2005to Sep 2007
- 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 55 years
- Women only
- No healthy volunteers
- 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 3 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).
- 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.
- Headache for 15 days per month or greater in any of the three months (90 days) preceding the Screening Visit.
- 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.
Show all 19Show fewer
- History of simple analgesic intake on greater than/equal 15 days per month for greater than/equal 3 months.
- Failed two or more adequate treatments of migraine prophylaxis, where failure is defined as a lack of efficacy with a treatment duration of at least 8 weeks or withdrawal of treatment due to treatment intolerance.
- Uncontrolled hypertension at the Screening Visit, defined as systolic blood pressure >140mmHg or diastolic blood pressure >90mmHg.
- Taking cyclosporine and/or aminoglycosides.
- 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.
- Concurrently participating in another clinical study or investigational drug trial or has participated within the previous 3 months or is planning to participate in another drug or device study at any time during this study (screening through follow-up) or has had previous exposure to GW274150 in Part 1 of the study.
- Felt to be at risk of non-compliance (for taking study medication or for completing the electronic diary (e-diary)), in the doctor's opinion.
- Pregnant or nursing women.
- History of, or risk factors for, HIV, Hepatitis B and Hepatitis C.
- Past or present disease, which as judged by the doctor, may affect the outcome of this study. These diseases include, but are not limited to history of liver or renal disease in the 6 months prior to screening.
- Clinically significant abnormalities in safety laboratory analysis at the Screening Visit, particularly any abnormal liver or pancreatic function test at the Screening Visit.
- Not covered by social security.
Trial locations and contacts
62 sites in 9 countries.
62 sites in 9 countries
Netherlands12 sites
GSK Investigational Site
Blaricum, 1261 AN
GSK Investigational Site
Eindhoven, 5623 EJ
GSK Investigational Site
Etten-Leur, 4872 LA
GSK Investigational Site
Geldermalsen, 4191 AH
GSK Investigational Site
Grubbenvorst, 5971 BB
GSK Investigational Site
Heerlen, 6419 PC
GSK Investigational Site
Hengelo, 7555 DL
GSK Investigational Site
Hoogwoud, 1718 BG
GSK Investigational Site
Nijmegen, 6532 SZ
GSK Investigational Site
Spijkenisse, 3207 NB
GSK Investigational Site
Venray, 5801 CE
GSK Investigational Site
Zwolle, 8011 JW
France10 sites
GSK Investigational Site
Anzin, 59410
GSK Investigational Site
Chilly-Mazarin, 91380
GSK Investigational Site
Évreux, 27000
GSK Investigational Site
Lille, 59037
GSK Investigational Site
Luynes, 37230
GSK Investigational Site
Montbrison, 42600
GSK Investigational Site
Toulouse, 31300
GSK Investigational Site
Tours, 37100
GSK Investigational Site
Vieux-Condé, 59690
GSK Investigational Site
Voiron, 38506
Germany9 sites
GSK Investigational Site
Berlin, State of Berlin, 10117
GSK Investigational Site
Berlin, State of Berlin, 10435
GSK Investigational Site
Berlin, State of Berlin, 10961
GSK Investigational Site
Essen, North Rhine-Westphalia, 45122
GSK Investigational Site
Hüttenberg, Hesse, 35625
GSK Investigational Site
Kiel, Schleswig-Holstein, 24149
GSK Investigational Site
Münster, North Rhine-Westphalia, 48149
GSK Investigational Site
Weinheim, Baden-Wurttemberg, 69469
GSK Investigational Site
Wiesbaden, Hesse, 65189
Italy7 sites
GSK Investigational Site
Catania, Sicily, 95124
GSK Investigational Site
Feltre (BL), Veneto, 32032
GSK Investigational Site
Florence, Tuscany, 50139
GSK Investigational Site
Genoa, Liguria, 16132
GSK Investigational Site
Modena, Emilia-Romagna, 41100
GSK Investigational Site
Rome, Lazio, 00163
GSK Investigational Site
Sestri Ponente (GE), Liguria, 16153
Norway7 sites
GSK Investigational Site
Bergen, 5007
GSK Investigational Site
Elverum, 2408
GSK Investigational Site
Hamar, 2317
GSK Investigational Site
Hønefoss, N-3515
GSK Investigational Site
Lier, 3400
GSK Investigational Site
Oslo, 0277
GSK Investigational Site
Sandvika, N-1338
Spain6 sites
GSK Investigational Site
Ávila, 05071
GSK Investigational Site
Barcelona, 08003
GSK Investigational Site
Madrid, 28034
GSK Investigational Site
Madrid, 28046
GSK Investigational Site
Oviedo, 33006
GSK Investigational Site
Valencia, 46010
Finland5 sites
GSK Investigational Site
Helsinki, 00100
GSK Investigational Site
Jyväskylä, 40100
GSK Investigational Site
Mikkeli, 50100
GSK Investigational Site
Tampere, 33210
GSK Investigational Site
Turku, 20100
Belgium3 sites
GSK Investigational Site
Antwerp, 2018
GSK Investigational Site
Leuven, 3000
GSK Investigational Site
Liège, 4000
Denmark3 sites
GSK Investigational Site
Glostrup Municipality, DK-2600
GSK Investigational Site
Odense C, 5000
GSK Investigational Site
Oelstykke, 3650
About this study
Official title: A Multicentre, Two-part, Randomised, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Tolerability and Pharmacokinetics of the iNOS Inhibitor GW274150 Administered up to 120mg Daily for 12 Weeks in the Prophylactic Treatment of Migraine.
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 prevention 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 prophylactic treatment of migraine headache.
- Conditions
- Migraine Disorders
- Being tested
- GW274150, Placebo
- Keywords
- Productivity, Efficacy, without aura, iNOS, Safety, Nitric Oxide, Pharmacokinetics, GW274150, with aura, Migraine, Prophylaxis, Quality of Life
- 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
The tablets used in this study will contain either 5mg or 30mg of GW274150
PlaceboOther
Placebo to Match GW274150
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | GW274150 - 5mg or 30mg Receives: Drug: GW274150; Other: Placebo |
| Arm 2 | Placebo comparator | Placebo to match GW274150 Receives: Drug: GW274150; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of a migraine headache day on each day during the 4-week baseline period and the 12-week treatment period.
Measured: 12 Weeks
Secondary outcomes (1)
Change from baseline in the number of migraine headache days, migraine attacks, mean peak migraine pain severity and mean migraine headache duration for each 4 week treatment period and over the entire treatment period.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2005 (estimated)
- Study startOct 2005
- Primary completionSep 2007
- Study completionSep 2007
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 430 participants (actual)
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
- NCT00242866
- Sponsor's protocol ID
- NOS103325
- Status last verified
- Sep 2015
- First submitted
- 19 Oct 2005
- Last updated
- 9 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Two-part, Randomised, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Tolerability and Pharmacokinetics of the iNOS Inhibitor GW274150 Administered up to 120mg Daily for 12 Weeks in the Prophylactic Treatment of Migraine.
- ClinicalTrials.gov ID
- NCT00242866
- Acronym / sponsor ID
- NOS103325
- Conditions
- Migraine Disorders
- Keywords
- Productivity, Efficacy, without aura, iNOS, Safety, Nitric Oxide, Pharmacokinetics, GW274150
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 430 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 21 Oct 2005 (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 prevention 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 prophylactic treatment of migraine headache.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: GW274150, Other: PlaceboGW274150 - 5mg or 30mg |
| Arm 2 | Placebo comparator | Drug: GW274150, Other: PlaceboPlacebo to match GW274150 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 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 3 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).
- 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.
Key exclusion criteria (19 listed)
- As a result of the medical interview, physical examination or screening investigations, that the doctor considers the subject unfit for the study.
- Headache for 15 days per month or greater in any of the three months (90 days) preceding the Screening Visit.
- 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.
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 |
|---|---|---|
| GW274150The tablets used in this study will contain either 5mg or 30mg of GW274150 | Drug | Arm 1, Arm 2 |
| PlaceboPlacebo to Match GW274150 | Other | Arm 1, Arm 2 |
Primary outcome
Occurrence of a migraine headache day on each day during the 4-week baseline period and the 12-week treatment period.
Time frame: 12 Weeks
1 secondary outcome
Change from baseline in the number of migraine headache days, migraine attacks, mean peak migraine pain severity and mean migraine headache duration for each 4 week treatment period and over the entire treatment period.
Time frame: 12 Weeks
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 9 May 2016.
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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
62 sites in 9 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, run by GlaxoSmithKline at 62 sites in 9 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 7 inclusion and 19 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 9 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 sites in Netherlands, France, Germany, Italy, Norway and 4 more countries. 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 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?
Occurrence of a migraine headache day on each day during the 4-week baseline period and the 12-week treatment period. (time frame: 12 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 9 May 2016.