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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00319137
First received: April 26, 2006
Last updated: May 31, 2012
Last verified: February 2011
  Purpose

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.


Condition Intervention Phase
Migraine Disorders
Migraine
Drug: GW274150
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

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

Estimated Enrollment: 126
Study Start Date: December 2005
Intervention Details:
    Drug: GW274150
    Other Name: GW274150
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00319137

Locations
Australia, South Australia
GSK Investigational Site
Adelaide, South Australia, Australia, 5000
New Zealand
GSK Investigational Site
Auckland, New Zealand, 1311
GSK Investigational Site
Christchurch, New Zealand, 8001
GSK Investigational Site
Hamilton, New Zealand, 2001
GSK Investigational Site
Wellington, New Zealand, 6035
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00319137     History of Changes
Other Study ID Numbers: NOS102512
Study First Received: April 26, 2006
Last Updated: May 31, 2012
Health Authority: New Zealand: Food Safety Authority
Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by GlaxoSmithKline:
GW274150
Nitric Oxide
acute migraine

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 23, 2014