Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00269022




Registration number
NCT00269022
Ethics application status
Date submitted
21/12/2005
Date registered
23/12/2005
Date last updated
18/05/2009

Titles & IDs
Public title
Use Of SB-705498 In The Acute Treatment Of Migraine
Scientific 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.
Secondary ID [1] 0 0
SB-705498/008
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Migraine, Acute 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 - SB-705498

Treatment: Drugs: SB-705498
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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).
Timepoint [1] 0 0
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0

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

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
Crossover
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
1/01/2006
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)
NSW
Recruitment hospital [1] 0 0
GSK Investigational Site - Randwick
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Ontario
Country [2] 0 0
Netherlands
State/province [2] 0 0
Leiden
Country [3] 0 0
United Kingdom
State/province [3] 0 0
Cambridgeshire

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

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT00269022
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials, MD
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/NCT00269022