Headache, MigrainePhase 1/2NCT00957983
EP4-receptor Antagonism and Prostaglandin E2 (PGE2) in a Human Headache Model
A Phase 1/2 study testing BGC20-1531 in people with Headache, Migraine, run by Danish Headache Center at 1 site in Denmark.
Trial summary
The purpose of this study is to determine whether EP-4 receptor antagonist can prevent the headache expected during a Prostaglandin E2 infusion. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Headache, Migraine
- What is being tested?
- BGC20-1531
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2009to Feb 2010
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether EP-4 receptor antagonist can prevent the headache expected during a Prostaglandin E2 infusion.
- Conditions
- Headache, Migraine
- Being tested
- BGC20-1531
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BGC20-1531Drug
Also called EP-4 receptor antagonist
oral administration followed by Prostaglandin E2 infusion
| Study group | Role | What they receive |
|---|---|---|
| BGC20-1531 200mg | Active comparator | Not described Receives: Drug: BGC20-1531 |
| sugar pill | Placebo comparator | Not described Receives: Drug: BGC20-1531 |
| BGC20-1531 400mg | Active comparator | Not described Receives: Drug: BGC20-1531 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache
Measured: 24 hours
Secondary outcomes (1)
rCBF, blood flow, diameter of STA/RA, HR, BP
Measured: in-hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Headache, MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Headache Center
- Sponsor type
- University, hospital or other
- Investigators
- Messoud Ashina, MD, PhD, Principal investigator, Danish Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00957983
- Sponsor's protocol ID
- BGC20-1531-04
- Status last verified
- Sep 2009
- First submitted
- 12 Aug 2009
- Last updated
- 11 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EP4-receptor Antagonism and Prostaglandin E2 (PGE2) in a Human Headache Model
- ClinicalTrials.gov ID
- NCT00957983
- Acronym / sponsor ID
- BGC20-1531-04
- Conditions
- Headache, Migraine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 13 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether EP-4 receptor antagonist can prevent the headache expected during a Prostaglandin E2 infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BGC20-1531 200mg | Active comparator | Drug: BGC20-1531 |
| sugar pill | Placebo comparator | Drug: BGC20-1531 |
| BGC20-1531 400mg | Active comparator | Drug: BGC20-1531 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy volunteers
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BGC20-1531Also: EP-4 receptor antagonistoral administration followed by Prostaglandin E2 infusion | Drug | BGC20-1531 200mg, BGC20-1531 400mg, sugar pill |
Primary outcome
Headache
Time frame: 24 hours
1 secondary outcome
rCBF, blood flow, diameter of STA/RA, HR, BP
Time frame: in-hospital
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Messoud Ashina, MD, PhD principal investigator
Danish Headache Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BGC20-1531 in people with Headache, Migraine, run by Danish Headache Center at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2011.