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.

• Conditions: Prophylaxis of migraine headache

• Registration Number: EUCTR2005-001335-30-BE
• Lead Sponsor: GlaxoSmithKline R&D

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10-04
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 375

Inclusion Criteria

Subjects, otherwise healthy, suffering from migraine with or without aura, according to 2004 IHS criteria 1.1 and 1.2.1 (see Appendix 2 of protocol).

Subject has had migraine for at least one year, and the age of onset was prior to 50 years.

Subject has consistent migraine headache over time (i.e., incidence and severity).

Subject had at least 3 migraine headache attacks but less than 15 headache days(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.

Subject is 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, including 12–lead ECG. A subject with a clinical abnormality or laboratory parameters outside the reference range may be included only if the Investigator considers that the finding will not introduce additional risk factors and will not interfere with the study procedures.

A female is eligible to enter and participate in this study if she is of:
a) non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal (>1 year since last menstrual cycle), had a documented tubal ligation or is surgically sterilized); or, b) child-bearing potential, has a negative pregnancy test (urine) at screen, and agrees to one of the following:

1. Complete abstinence from intercourse from 2 weeks prior to administration of the investigational product, throughout the Treatment Period and for a minimum of one week after completion or premature discontinuation from investigational product; or

2. Consistent and correct use of an acceptable method of birth control as outlined in the protocol.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. As a result of the medical interview, physical examination or screening
investigations, that the Investigator or appropriately qualified designee considers the
subject unfit for the study.
2. Subject has headache for 15 days per month or greater in any of the three months (90
days) preceding the Screening Visit.
3. Subject has history of alcohol, substance or drug abuse within the last year.
4. Subject has taken a migraine prophylactic medication within 1 month of the
Screening Visit.
5. Subject uses an opiate as first line acute treatment for migraine attacks.
6. Subject has history of ergotamine, triptan, opioid, or combination medication intake
on =10 days per month on a regular basis for =3 months.
7. Subject has history of simple analgesic intake on =15 days per month for =3months.
8. Subject has 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.
9. Subject has uncontrolled hypertension at the Screening Visit, defined as persistent
(after 3 readings) systolic blood pressure >140mmHg or diastolic blood pressure
>90mmHg; measured after 10 minutes of rest.
10. Subject is taking cyclosporine and/or aminoglycosides.
11. Evidence of renal impairment - calculated creatinine clearance < 60ml/min
(Cockroft-Gault formula, Appendix 4) or clinically relevant finding (more than 1+
protein or blood) on urinalysis (including microscopy).
12. Subject has a history of drug or other allergy which, in the opinion of the
Investigator, makes the subject unsuitable for participation in the study.
13. Subject is 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 followup)
or has had previous exposure to GW274150 in Part 1 of the study.
14. Subject is felt to be at risk of non-compliance (for taking study medication or for
completing the electronic diary (e-diary)), in the Investigator’s opinion.
15. Pregnant or nursing women.
16. History of, or risk factors for, HIV, Hepatitis B and Hepatitis C.
17. Past or present disease, which as judged by the investigator, 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.
18. Clinically significant abnormalities in safety laboratory analysis at the Screening
Visit. Particularly any liver function test (including ALT, AST and ALP) or
pancreatic function test (pancreatic amylase or lipase) >1.5 x upper limit normal
(ULN) at the Screening Visit.
19. The subject is not covered by social security (requirement for subjects recruited in
France)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified