Use Of GW274150 In The Prophylactic Treatment Of Migraine

May 5, 2016 updated by: GlaxoSmithKline

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

430

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerpen, Belgium, 2018
        • GSK Investigational Site
      • Leuven, Belgium, 3000
        • GSK Investigational Site
      • Liège, Belgium, 4000
        • GSK Investigational Site
  • Denmark
      • Glostrup, Denmark, DK-2600
        • GSK Investigational Site
      • Odense C, Denmark, 5000
        • GSK Investigational Site
      • Oelstykke, Denmark, 3650
        • GSK Investigational Site
  • Finland
      • Helsinki, Finland, 00100
        • GSK Investigational Site
      • Jyvaskyla, Finland, 40100
        • GSK Investigational Site
      • Mikkeli, Finland, 50100
        • GSK Investigational Site
      • Tampere, Finland, 33210
        • GSK Investigational Site
      • Turku, Finland, 20100
        • GSK Investigational Site
  • France
      • Anzin, France, 59410
        • GSK Investigational Site
      • Chilly Mazarin, France, 91380
        • GSK Investigational Site
      • Evreux, France, 27000
        • GSK Investigational Site
      • Lille Cedex, France, 59037
        • GSK Investigational Site
      • Luynes, France, 37230
        • GSK Investigational Site
      • Montbrison, France, 42600
        • GSK Investigational Site
      • Toulouse, France, 31300
        • GSK Investigational Site
      • Tours, France, 37100
        • GSK Investigational Site
      • Vieux Condé, France, 59690
        • GSK Investigational Site
      • Voiron, France, 38506
        • GSK Investigational Site
  • Germany
      • Berlin, Germany, 10117
        • GSK Investigational Site
      • Berlin, Germany, 10435
        • GSK Investigational Site
      • Berlin, Germany, 10961
        • GSK Investigational Site
    • Baden-Wuerttemberg
      • Weinheim, Baden-Wuerttemberg, Germany, 69469
        • GSK Investigational Site
    • Hessen
      • Huettenberg, Hessen, Germany, 35625
        • GSK Investigational Site
      • Wiesbaden, Hessen, Germany, 65189
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Essen, Nordrhein-Westfalen, Germany, 45122
        • GSK Investigational Site
      • Muenster, Nordrhein-Westfalen, Germany, 48149
        • GSK Investigational Site
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24149
        • GSK Investigational Site
  • Italy
    • Emilia-Romagna
      • Modena, Emilia-Romagna, Italy, 41100
        • GSK Investigational Site
    • Lazio
      • Roma, Lazio, Italy, 00163
        • GSK Investigational Site
    • Liguria
      • Genova, Liguria, Italy, 16132
        • GSK Investigational Site
      • Sestri Ponente (GE), Liguria, Italy, 16153
        • GSK Investigational Site
    • Sicilia
      • Catania, Sicilia, Italy, 95124
        • GSK Investigational Site
    • Toscana
      • Firenze, Toscana, Italy, 50139
        • GSK Investigational Site
    • Veneto
      • Feltre (BL), Veneto, Italy, 32032
        • GSK Investigational Site
  • Netherlands
      • Blaricum, Netherlands, 1261 AN
        • GSK Investigational Site
      • Eindhoven, Netherlands, 5623 EJ
        • GSK Investigational Site
      • Etten-leur, Netherlands, 4872 LA
        • GSK Investigational Site
      • Geldermalsen, Netherlands, 4191 AH
        • GSK Investigational Site
      • Grubbenvorst, Netherlands, 5971 BB
        • GSK Investigational Site
      • Heerlen, Netherlands, 6419 PC
        • GSK Investigational Site
      • Hengelo, Netherlands, 7555 DL
        • GSK Investigational Site
      • Hoogwoud, Netherlands, 1718 BG
        • GSK Investigational Site
      • Nijmegen, Netherlands, 6532 SZ
        • GSK Investigational Site
      • Spijkenisse, Netherlands, 3207 NB
        • GSK Investigational Site
      • Venray, Netherlands, 5801 CE
        • GSK Investigational Site
      • Zwolle, Netherlands, 8011 JW
        • GSK Investigational Site
  • Norway
      • Bergen, Norway, 5007
        • GSK Investigational Site
      • Elverum, Norway, 2408
        • GSK Investigational Site
      • Hamar, Norway, 2317
        • GSK Investigational Site
      • Hønefoss, Norway, N-3515
        • GSK Investigational Site
      • Lier, Norway, 3400
        • GSK Investigational Site
      • Oslo, Norway, 0277
        • GSK Investigational Site
      • Sandvika, Norway, N-1338
        • GSK Investigational Site
  • Spain
      • Avila, Spain, 05071
        • GSK Investigational Site
      • Barcelona, Spain, 08003
        • GSK Investigational Site
      • Madrid, Spain, 28046
        • GSK Investigational Site
      • Madrid, Spain, 28034
        • GSK Investigational Site
      • Oviedo, Spain, 33006
        • GSK Investigational Site
      • Valencia, Spain, 46010
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
GW274150 - 5mg or 30mg
Drug: GW274150
The tablets used in this study will contain either 5mg or 30mg of GW274150
Other: Placebo
Placebo to Match GW274150
Placebo Comparator: Arm 2
Placebo to match GW274150
Drug: GW274150
The tablets used in this study will contain either 5mg or 30mg of GW274150
Other: Placebo
Placebo to Match GW274150

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

October 19, 2005

First Submitted That Met QC Criteria

October 19, 2005

First Posted (Estimate)

October 21, 2005

Study Record Updates

Last Update Posted (Estimate)

May 9, 2016

Last Update Submitted That Met QC Criteria

May 5, 2016

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NOS103325

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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