Use Of GW274150 In The Prophylactic Treatment Of Migraine

• Register: ClinicalTrials.gov
• Last refreshed on: 17 May 2016
• Main ID: NCT00242866
• Date of registration: 19/10/2005
• Prospective Registration: No
• Primary sponsor: GlaxoSmithKline
• Public title: Use Of GW274150 In The Prophylactic Treatment Of Migraine
• Scientific 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.
• Date of first enrolment: October 2005
• Target sample size: 430
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00242866
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
• Phase: Phase 2

Countries of recruitment

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

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Migraine Disorders

Intervention(s)

Other: Placebo

Drug: GW274150

Primary Outcome(s)

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]

Secondary Outcome(s)

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]

Secondary ID(s)

NOS103325

Source(s) of Monetary Support

Please refer to primary and secondary sponsors