CClinicalTrials.gg
Sign In
CompletedNCT00269022Updated May 18, 2009

Use Of SB-705498 In The Acute Treatment Of Migraine

A Phase 2 interventional study of SB-705498 in Migraine, Acute, sponsored by GlaxoSmithKline. Completed at 4 sites in 4 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2009-05-18.

Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Migraine, Acute

Browse trials for

Keywords

  • SB-705498 acute migraine single dose TRPV1 combination inpatient outpatient study
03

In context

Migraine Disorders

1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.

This study's enrollment of 70 is below the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single
Enrollment
70 participants

Interventions

  • DrugSB-705498
06

What researchers measure

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.

07

Study locations

4 sites
  • GSK Investigational Site
    Randwick, New South Wales 2031, Australia
  • GSK Investigational Site
    Toronto, Ontario M1L 4S4, Canada
  • GSK Investigational Site
    Leiden, 2333 ZA, Netherlands
  • GSK Investigational Site
    Cambridge, Cambridgeshire CB2 2GG, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00269022
Lead sponsor
GlaxoSmithKline
First posted
Dec 23, 2005
Start date
Jan 2006
Last update
May 18, 2009

Study contacts

GSK Clinical Trials, MD
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2009. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Migraine Disorders→

Other studies from this sponsor

GlaxoSmithKline

Start the discussion