NCT00319137

Brief 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 treatment 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 acute treatment of migraine headache.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P75+ for phase_2

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 27, 2006

Completed
Last Updated

June 4, 2012

Status Verified

February 1, 2011

First QC Date

April 26, 2006

Last Update Submit

May 31, 2012

Conditions

Migraine DisordersMigraine

Keywords

GW274150Nitric Oxideacute migraine

Outcome Measures

Primary Outcomes (1)

  • Dose of GW274150 that results in 50% of subjects reporting cessation of migraine pain by 2 hours and to study the relationship between dose and therapeutic response.

Secondary Outcomes (1)

  • Adverse events following treatment

Interventions

GW274150DRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 1 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).
  • Typically have moderate to severe migraine pain preceded by an identifiable mild pain phase.
  • 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.

You may not qualify if:

  • As a result of the medical interview, physical examination or screening investigations, that the doctor considers the subject unfit for the study.
  • 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.
  • Do not receive migraine relief from a triptan migraine treatment.
  • Uncontrolled hypertension at the Screening Visit, defined as systolic blood pressure \>140mmHg or diastolic blood pressure \>90mmHg.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

GSK Investigational Site

Adelaide, South Australia, 5000, Australia

Location

GSK Investigational Site

Auckland, 1311, New Zealand

Location

GSK Investigational Site

Christchurch, 8001, New Zealand

Location

GSK Investigational Site

Hamilton, 2001, New Zealand

Location

GSK Investigational Site

Wellington, 6035, New Zealand

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

GW 274150

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2006

First Posted

April 27, 2006

Study Start

December 1, 2005

Last Updated

June 4, 2012

Record last verified: 2011-02

Locations

AU(1)NZ(4)