GSK: Protocol Summary for SB-705498/008

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Protocol Summary for SB-705498/008

Protocol Summary
Protocol Id:	SB-705498/008
Secondary Ids:
Title:	A single blind, placebo controlled, multi-centre study to investigate the pharmacokinetics, safety, tolerability and pharmacodynamics of the TRPV1 antagonist SB-705498 against the pain of acute migraine.
Phase:	Phase 2
Acronym:
FDA Regulated Intervention?:
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?:	no
Study Type:	interventional
Oversight Authority:	Australia: Therapeutic Goods Administration
Collaborators:
Brief Summary:	Despite the success of the triptan class of drugs, approximately 60% of patients who take medication at the moderate to severe pain stage of acute migraine, still have pain of mild or greater degree at 2 hrs post dose. SB-705498 is a novel, first in class TRPV1 receptor antagonist under development for the treatment of migraine pain. Preclinical experiments have demonstrated that the TRPV1 receptor is expressed both centrally and peripherally in the trigeminal system and inhibition of TRPV1 with SB-705498 can both prevent and reverse established central sensitisation.
Detailed Description:
Record Verification Date:	September 2009
Status:	Completed
Why Study Stopped:
Study Start Date:	January 2006
Study Completion Date:
Study Completion Date Type:
Primary Completion Date:
Primary Completion Date Type:
Primary Purpose:	Treatment
Allocation:	Randomized
Masking:	Single Blind
Masked Subject:	None
Masked Caregiver:	None
Masked Investigator:	None
Masked Assessor:	None
Study Design (Assignment):	Crossover Assignment
Study Classification (Endpoint):	Efficacy Study
Primary Outcomes:	Percentage of subjects who are pain free at 2 hrs post-dose (e.g., have moderate to severe pain at baseline and no pain at 2 hrs post-dose).
Secondary Outcomes:	Pain free at 30mins, 1,3,4,5&6hrs Headache relief and absence/presence of associated symptoms at 30 mins, 1,2,3,4,5&6hrs Additional migraine medication Safety tests ( e.g., continuous ECG, laboratory tests) Heat pain thresholds.
Conditions:	Migraine Disorders
Keywords:	SB-705498 acute migraine single dose TRPV1 combination inpatient outpatient study
Eligibility Criteria:	Click to view inclusion/exclusion criteria Inclusion criteria: •Healthy subjects suffering from moderate to severe migraine headache with or without aura. •Women of child bearing potential must use an effective method of contraception. •Have had at least a 1 year history of migraine and the age of onset was prior to 50 years. •Suffering 1 to 6 migraine attacks per month for at least the last 3 months and should have at least 48 hours free of headache between migraine attacks. Exclusion criteria: •Headache for 15 days/month or greater in any of the three months (90 days) preceding entry into the study. •Use of migraine medications (e.g., ergotamine, triptan, opioid, or combination medication) on >/= 10 days per month on a regular basis for >/= 3 months. •Use of analgesics >/=15 days per month for >/=3 months, uses an opiate (except codeine) as first line treatment for migraine. •Migraine symptoms do not respond to any of the triptan drugs (e.g., Imitrex, Relpax, Maxalt). •Have uncontrolled hypertension or a history/ presence of multiple cardiovascular risk factors such as, but not limited to family history, myocardial infarction, coronary artery disease, vasospastic angina, heart failure, cardiac arrhythmias or history or presence of cerebrovascular disease, including transient ischemic attack, stroke or peripheral arterial disease. •History of alcohol, substance or drug abuse within the last year. •Participation in a trial with a new chemical entity within 3 months before the start of the study. •Participation in any other research trial within 30 days prior to the first dose of current study medication is not permitted.
Gender:	Both
Minimum Age:	18 Years
Maximum Age:	65 Years
Enrollment:	70
Enrollment Type:
Healthy Volunteers?:	no
Central Contact:	US GSK Clinical Trials Call Center
Central Contact Phone:	877-379-3718
Central Contact Email:	GSKClinicalSupportHD@gsk.com
Backup Central Contact:	EU GSK Clinical Trials Call Center
Backup Central Contact Phone:	+44 (0) 20 8990 4466
Backup Central Contact Email:	GSKClinicalSupportHD@gsk.com
Overall Study Official:	GSK Clinical Trials
Overall Study Official Affiliation:	GlaxoSmithKline
Overall Study Official Role:	Study Director
Responsible Party Name/Official Title:	Cheri Hudson; Clinical Disclosure Advisor
Responsible Party Organization:	GSK Clinical Disclosure
Location and Contact Information:	Click to view location information Australia (click to view all sites in Australia) GSK Investigational Site Randwick, New South Wales, 2031; Completed; Canada (click to view all sites in Canada) GSK Investigational Site Toronto, Ontario, M1L 4S4; Completed; Netherlands (click to view all sites in Netherlands) GSK Investigational Site LEIDEN, , 2333 ZA; Completed; United Kingdom (click to view all sites in United Kingdom) GSK Investigational Site Cambridge, Cambridgeshire, CB2 2GG; Completed;

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Protocol Summary for SB-705498/008