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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00319137




Registration number
NCT00319137
Ethics application status
Date submitted
26/04/2006
Date registered
27/04/2006
Date last updated
4/06/2012

Titles & IDs
Public title
An Adaptive Design Trial Of GW274150 In The Treatment Of Acute Migraine
Scientific 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
Secondary ID [1] 0 0
NOS102512
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Migraine Disorders 0 0
Migraine 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GW274150

Treatment: Drugs: GW274150
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Adverse events following treatment
Timepoint [1] 0 0

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
GSK Investigational Site - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch
Country [3] 0 0
New Zealand
State/province [3] 0 0
Hamilton
Country [4] 0 0
New Zealand
State/province [4] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT00319137
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00319137