NCT00957983

Brief Summary

The purpose of this study is to determine whether EP-4 receptor antagonist can prevent the headache expected during a Prostaglandin E2 infusion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

August 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 13, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

January 11, 2011

Status Verified

September 1, 2009

Enrollment Period

6 months

First QC Date

August 12, 2009

Last Update Submit

January 10, 2011

Conditions

Headache, Migraine

Outcome Measures

Primary Outcomes (1)

  • Headache

    24 hours

Secondary Outcomes (1)

  • rCBF, blood flow, diameter of STA/RA, HR, BP

    in-hospital

Study Arms (3)

BGC20-1531 200mg

ACTIVE COMPARATOR
Drug: BGC20-1531

sugar pill

PLACEBO COMPARATOR
Drug: BGC20-1531

BGC20-1531 400mg

ACTIVE COMPARATOR
Drug: BGC20-1531

Interventions

BGC20-1531DRUG

oral administration followed by Prostaglandin E2 infusion

Also known as: EP-4 receptor antagonist
BGC20-1531 200mgBGC20-1531 400mgsugar pill

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers

You may not qualify if:

  • Tension headache
  • All other primary forms of headache
  • Cardiovascular, Central Nervous system (CNS) and autoimmune diseases
  • Gastrointestinal disease
  • Previous or clinical signs of mental illness or substance abuse.
  • Participation in a clinical study of a medicinal product without regulatory approval or marketing authorisation within 1 month prior to this trial
  • Pregnancy/nursing
  • Daily intake of medication (except oral contraceptives)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danish Headache Center

Glostrup Municipality, 2600, Denmark

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

N-(4-(4-(5-methoxypyridin-2-yl)phenoxymethyl)-5-methylfuran-2-carbonyl)-2-methylbenzenesulfonamide

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Messoud Ashina, MD, PhD

    Danish Headache Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 12, 2009

First Posted

August 13, 2009

Study Start

August 1, 2009

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

January 11, 2011

Record last verified: 2009-09

Locations

DK(1)