Use Of SB-705498 In The Acute Treatment Of Migraine

Phase 2

Completed

• Conditions: Migraine, Acute

• Registration Number: NCT00269022
• Lead Sponsor: GlaxoSmithKline

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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2005-12-21
• Study First Submitted QC: 2005-12-22
• Study First Posted: 2005-12-23
• Study Start: 2006-01
• Status Verified: 2009-05
• Last Update Submitted: 2009-05-15
• Last Update Posted: 2009-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

GSK Investigational Site; 🇬🇧 Cambridge, Cambridgeshire, United Kingdom