NCT00269022

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.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
4 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 23, 2005

Completed
9 days until next milestone

Study Start

First participant enrolled

January 1, 2006

Completed
Last Updated

May 18, 2009

Status Verified

May 1, 2009

First QC Date

December 21, 2005

Last Update Submit

May 15, 2009

Conditions

Migraine, Acute

Keywords

SB-705498 acute migraine single dose TRPV1 combination inpatient outpatient study

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • 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.

Interventions

SB-705498DRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

GSK Investigational Site

Randwick, New South Wales, 2031, Australia

Location

GSK Investigational Site

Toronto, Ontario, M1L 4S4, Canada

Location

GSK Investigational Site

Leiden, 2333 ZA, Netherlands

Location

GSK Investigational Site

Cambridge, Cambridgeshire, CB2 2GG, United Kingdom

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

SB 705498

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • GSK Clinical Trials, MD

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 21, 2005

First Posted

December 23, 2005

Study Start

January 1, 2006

Last Updated

May 18, 2009

Record last verified: 2009-05

Locations

GB(1)CA(1)NL(1)AU(1)