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An Adaptive Design Trial Of GW274150 In The Treatment Of Acute Migraine

Primary Purpose

Migraine Disorders, Migraine

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
GW274150
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine Disorders focused on measuring GW274150, Nitric Oxide, acute migraine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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. Exclusion Criteria: 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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Outcomes

Primary Outcome Measures

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 Outcome Measures

Adverse events following treatment

Full Information

First Posted
April 26, 2006
Last Updated
May 31, 2012
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00319137
Brief Title
An Adaptive Design Trial Of GW274150 In The Treatment Of Acute Migraine
Official Title
A Randomized, Single-Blind, Single-Attack, Placebo-Controlled, Adaptive Design Study to Assess the Safety and Efficacy of Doses of 5-180 mg of the iNOS Inhibitor GW274150 in the Treatment of Acute Migraine During the Mild Headache Phase
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Disorders, Migraine
Keywords
GW274150, Nitric Oxide, acute migraine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Randomized
Enrollment
126 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
GW274150
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Adverse events following treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
GSK Investigational Site
City
Auckland
ZIP/Postal Code
1311
Country
New Zealand
Facility Name
GSK Investigational Site
City
Christchurch
ZIP/Postal Code
8001
Country
New Zealand
Facility Name
GSK Investigational Site
City
Hamilton
ZIP/Postal Code
2001
Country
New Zealand
Facility Name
GSK Investigational Site
City
Wellington
ZIP/Postal Code
6035
Country
New Zealand

12. IPD Sharing Statement

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An Adaptive Design Trial Of GW274150 In The Treatment Of Acute Migraine

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