Prophylaxis of migraine headache MedDRA version: 8.1 Level: LLT Classification code 10058734 Term: Migraine prophylaxis
Conditions
Interventions
Product Name: GW274150
Product Code: GW274150
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: GW274150F
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number
Sponsors
GlaxoSmithKline R&D
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In Part 2, females (childbearing and nonchildbearing potential), between 18 and 55 years of age. 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
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 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to estimate the dose-response and dose-safety relationships for GW274150 in the prophylaxis of migraine.;Secondary Objective: •To explore efficacy of each dose of GW274150 compared with placebo using various clinical endpoints in the prophylaxis of migraine headaches •To investigate the safety & tolerability of GW274150 in the prophylaxis of migraine headaches •To evaluate the pharmacokinetics of GW274150 •To evaluate the relationship between systemic GW274150 exposure and the prophylaxis of migraine headaches •To evaluate the relationship between systemic GW274150 exposure and safety and tolerability endpoints in migraineurs •To explore potential relationships between genetic variants and GW274150 efficacy endpoints •To determine the change in migraine-related quality of life, treatment satisfaction and productivity in subjects treated prophylactically with oral daily GW274150 compared to subjects treated prophylactically with placebo •To evaluate the effect of repeat dose treatment of GW274150 upon the generation of NO by reference to tyrosine and its nitrosylated derivative NO-tyrosine;Primary end point(s): The primary efficacy endpoint is the occurrence of a migraine headache day on each day during the 4-week baseline period and the 12-week treatment period, where a migraine headache day is defined as a calendar day with any occurrence of migraine headache pain of at least 30 minutes in duration. This analysis will be conducted after Part 1 and Part 2. | — |
Countries
Belgium, Denmark, Finland, Germany, Italy, Spain
Outcome results
None listed