Use Of GW274150 In The Prophylactic Treatment Of Migraine

Migraine Disorders Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00242866
• Other study ID #: NOS103325
• Status: Completed
• Phase: Phase 2
• First received: October 19, 2005
• Last updated: May 5, 2016
• Start date: October 2005
• Est. completion date: September 2007

Study information

• Verified date: September 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 430
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

• 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.

Related Conditions & MeSH terms

• Migraine Disorders

Intervention

Drug:
• GW274150
The tablets used in this study will contain either 5mg or 30mg of GW274150

Other:
• Placebo
Placebo to Match GW274150

Locations

Country	Name	City	State
Belgium	GSK Investigational Site	Antwerpen
Belgium	GSK Investigational Site	Leuven
Belgium	GSK Investigational Site	Liège
Denmark	GSK Investigational Site	Glostrup
Denmark	GSK Investigational Site	Odense C
Denmark	GSK Investigational Site	Oelstykke
Finland	GSK Investigational Site	Helsinki
Finland	GSK Investigational Site	Jyvaskyla
Finland	GSK Investigational Site	Mikkeli
Finland	GSK Investigational Site	Tampere
Finland	GSK Investigational Site	Turku
France	GSK Investigational Site	Anzin
France	GSK Investigational Site	Chilly Mazarin
France	GSK Investigational Site	Evreux
France	GSK Investigational Site	Lille Cedex
France	GSK Investigational Site	Luynes
France	GSK Investigational Site	Montbrison
France	GSK Investigational Site	Toulouse
France	GSK Investigational Site	Tours
France	GSK Investigational Site	Vieux Condé
France	GSK Investigational Site	Voiron
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Essen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Huettenberg	Hessen
Germany	GSK Investigational Site	Kiel	Schleswig-Holstein
Germany	GSK Investigational Site	Muenster	Nordrhein-Westfalen
Germany	GSK Investigational Site	Weinheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Wiesbaden	Hessen
Italy	GSK Investigational Site	Catania	Sicilia
Italy	GSK Investigational Site	Feltre (BL)	Veneto
Italy	GSK Investigational Site	Firenze	Toscana
Italy	GSK Investigational Site	Genova	Liguria
Italy	GSK Investigational Site	Modena	Emilia-Romagna
Italy	GSK Investigational Site	Roma	Lazio
Italy	GSK Investigational Site	Sestri Ponente (GE)	Liguria
Netherlands	GSK Investigational Site	Blaricum
Netherlands	GSK Investigational Site	Eindhoven
Netherlands	GSK Investigational Site	Etten-leur
Netherlands	GSK Investigational Site	Geldermalsen
Netherlands	GSK Investigational Site	Grubbenvorst
Netherlands	GSK Investigational Site	Heerlen
Netherlands	GSK Investigational Site	Hengelo
Netherlands	GSK Investigational Site	Hoogwoud
Netherlands	GSK Investigational Site	Nijmegen
Netherlands	GSK Investigational Site	Spijkenisse
Netherlands	GSK Investigational Site	Venray
Netherlands	GSK Investigational Site	Zwolle
Norway	GSK Investigational Site	Bergen
Norway	GSK Investigational Site	Elverum
Norway	GSK Investigational Site	Hamar
Norway	GSK Investigational Site	Hønefoss
Norway	GSK Investigational Site	Lier
Norway	GSK Investigational Site	Oslo
Norway	GSK Investigational Site	Sandvika
Spain	GSK Investigational Site	Avila
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Oviedo
Spain	GSK Investigational Site	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Belgium,  Denmark,  Finland,  France,  Germany,  Italy,  Netherlands,  Norway,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of a migraine headache day on each day during the 4-week baseline period and the 12-week treatment period.		12 Weeks
Secondary	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.		12 Weeks