MigrainePhase 2NCT00888680
Double-blind, Placebo-controlled Study of BGC20-1531 in Migraine
A Phase 2 study testing BGC20-1531 and Lactose in people with Migraine, run by Boston Scientific Corporation at 4 sites in 3 countries.
Trial summary
The study is being conducted to explore the safety and effectiveness of a new chemical entity, BGC20-1531, in subjects with a history of migraine. In this study subjects will treat a total of three migraine attacks with two different doses of BGC20-1531 and placebo, with at least one week wash out period between doses. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- BGC20-1531 and Lactose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Start not givento not given
- Phase
- Phase 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of migraine (with or without aura) according to the criteria of the International Headache Society.
- Age at onset of migraine less than 45.0 years.
- Males and females between 18.0 and 65.0 years of age inclusive.
- Be willing and able to give written informed consent.
- For female patients, a negative pregnancy test
- Sexually active participants and their partners should be using an effective method of contraception; combined hormonal or progestogen-only methods, IUD/IUS, diaphragm/condoms with spermicide or sterilisation.
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- History of 1-6 migraine attacks per month (with or without aura) in the 3 months prior to screening, with at least 48 hours freedom from headache between attacks.
- Patients receiving migraine prophylactic treatment can be enrolled, providing they are receiving only one drug for prophylaxis and the prescribed daily dose is not changed in the month prior to screening.
- Rescue medication is permitted in the study.
- Women with menstrual migraine (or who have suspected menstrual migraine or are subsequently diagnosed with menstrual migraine) may be included in the study and instructed to treat each consecutive attack with study medication (unless within the wash-out period).
- Patients who are willing and able to comply with study requirements including completion of the study diary.
- Patients who are taking prescribed medication for depression may be included providing this treatment has been stable for 3 months prior to screening and is expected to remain stable for the duration of the study.
- In the investigators opinion are suitable for inclusion in the study.
Who cannot join
- Patients with ≥15 headache days (migraine and non-migraine headaches combined) per month.
- Patients who take analgesics for any reason ≥15 days a month or triptans ≥10 days a month.
- Non-migraine headaches on more than 6 days per month.
- Patients with schizophrenia.
- Patients prescribed more than one migraine prophylaxis treatment.
- Patients receiving prophylaxis whose prescribed daily dose has changed within the month before screening.
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- Patients whose prophylactic treatment is not expected to remain stable for the duration of the study.
- Patients whose prophylactic treatment has been withdrawn within the month prior to study entry.
- Patients taking ergotamine, ergotamine derivatives or ergotamine combination products.
- Any relevant abnormality on history or examination including central nervous system, psychiatric (excluding depression), respiratory, cardiovascular or metabolic dysfunction.
- Abnormal laboratory findings suggesting infectious, endocrine, malignant disease or other systemic disorder; any isolated abnormal laboratory finding considered clinically relevant by the investigator at screening.
- Subjects with clinically significant abnormalities in 12-lead electrocardiogram (ECG), blood pressure and/or pulse at screening.
- Recent or clinically significant history of drug or alcohol abuse.
- Inability to communicate well with the investigator (ie, language problem, poor mental development or impaired cerebral function).
- Participation in a clinical study of an Investigational Medicinal Product (IMP) within the 3 months up to screening.
- Patient unable to commit to participating in the clinical study for up to 8 months or patient expecting any medical interventions during that time.
- Patients taking prescribed medication for depression, whose treatment has not been stable for 3 months up to screening and is not likely to remain stable for the duration of the study.
- Female patients who are pregnant or lactating.
- Patients taking any unapproved herbal remedies for treatment of depression or migraine e.g. feverfew, St Johns Wort. (Supplementary vitamins, minerals or homeopathic remedies will be permitted provided their intake is kept constant throughout the study).
- Patients with a history of lactose intolerance.
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Norway2 sites
Head and Neck Research Group
Oslo
Norwegian National Headache Centre
Trondheim
About this study
Official title: A Multinational, Multi-centre, Randomised, Double-blind, Placebo-controlled, 3-way Crossover Study in Migraine Patients, Treated With Two Doses of BGC20-1531 and Placebo
The study is being conducted to explore the safety and effectiveness of a new chemical entity, BGC20-1531, in subjects with a history of migraine. In this study subjects will treat a total of three migraine attacks with two different doses of BGC20-1531 and placebo, with at least one week wash out period between doses.
Read the detailed description
Migraine headache is estimated to affect 10-20% of the world population and is listed by the World Health Organisation in the top 20 causes of disabling conditions, and in the top four neurological disabling conditions. The most common therapies for acute migraine are non-steroidal anti-inflammatory drugs (NSAIDs) and triptans. However, many migraine sufferers do not experience sufficient relief from these treatments or cannot tolerate their gastrointestinal, cardiovascular and other side-effects.
Prostaglandin PGE2-induced sensory nerve sensitisation, neuropeptide release and cerebral vascular dilatation is thought to underlie migraine pain, particularly via activation of the EP4 receptor subtype. BGC20-1531 is an orally available EP4 receptor antagonist which inhibits prostaglandin-induced vasodilation of cranial blood vessels via a selective blockade of EP4 receptors reducing inflammation and migraine pain. As EP4 receptors are discretely localised, the overall safety profile of EP4 receptor antagonists may be improved compared to triptans and NSAIDs.
- Conditions
- Migraine
- Being tested
- BGC20-1531, Lactose
- Keywords
- Migraine, Headaches, Migraine headaches, Head pain
- Medical subject headings
- Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BGC20-1531Drug
BGC20-1531 administered orally
LactoseDrug
Placebo administered orally
| Study group | Role | What they receive |
|---|---|---|
| BGC20-1531 200 mg | Experimental | Not described Receives: Drug: BGC20-1531 |
| BGC20-1531 400mg | Experimental | Not described Receives: Drug: BGC20-1531 |
| Lactose | Placebo comparator | Not described Receives: Drug: Lactose |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effect of BGC20-1531 on headache response, defined as a decrease of headache from severe or moderate to mild or none at 2 hours post-dose without the use of rescue medication.
Measured: 2 hours
Secondary outcomes (4)
To evaluate the effect of BGC20-1531 on pain-freedom up to 48 hours post-dose without the use of rescue medication.
Measured: Up to 48 hours
To evaluate the effect of BGC20-1531 on headache response up to 48 hours post-dose (without the use of rescue medication).
Measured: Up to 48 hours
To evaluate the effect of BGC20-1531 on sustained headache relief and pain-freedom over a 24-hour and 48-hour period post-dose.
Measured: Up to 48 hours
To evaluate the safety of BGC20-1531.
Measured: Duration of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2009 (estimated)
Why it stopped: No patients enrolled. Delay due to optimisation of drug product formulation.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Messoud Ashina, MD, Principal investigator, Danish Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00888680
- Sponsor's protocol ID
- BGC20-1531-06
- Status last verified
- Jun 2022
- First submitted
- 27 Apr 2009
- Last updated
- 3 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multinational, Multi-centre, Randomised, Double-blind, Placebo-controlled, 3-way Crossover Study in Migraine Patients, Treated With Two Doses of BGC20-1531 and Placebo
- ClinicalTrials.gov ID
- NCT00888680
- Acronym / sponsor ID
- BGC20-1531-06
- Conditions
- Migraine
- Keywords
- Migraine, Headaches, Migraine headaches, Head pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients enrolled. Delay due to optimisation of drug product formulation.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- First posted
- 28 Apr 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 study is being conducted to explore the safety and effectiveness of a new chemical entity, BGC20-1531, in subjects with a history of migraine. In this study subjects will treat a total of three migraine attacks with two different doses of BGC20-1531 and placebo, with at least one week wash out period between doses.
Detailed description
Migraine headache is estimated to affect 10-20% of the world population and is listed by the World Health Organisation in the top 20 causes of disabling conditions, and in the top four neurological disabling conditions. The most common therapies for acute migraine are non-steroidal anti-inflammatory drugs (NSAIDs) and triptans. However, many migraine sufferers do not experience sufficient relief from these treatments or cannot tolerate their gastrointestinal, cardiovascular and other side-effects.
Prostaglandin PGE2-induced sensory nerve sensitisation, neuropeptide release and cerebral vascular dilatation is thought to underlie migraine pain, particularly via activation of the EP4 receptor subtype. BGC20-1531 is an orally available EP4 receptor antagonist which inhibits prostaglandin-induced vasodilation of cranial blood vessels via a selective blockade of EP4 receptors reducing inflammation and migraine pain. As EP4 receptors are discretely localised, the overall safety profile of EP4 receptor antagonists may be improved compared to triptans and NSAIDs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BGC20-1531 200 mg | Experimental | Drug: BGC20-1531 |
| BGC20-1531 400mg | Experimental | Drug: BGC20-1531 |
| Lactose | Placebo comparator | Drug: Lactose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Diagnosis of migraine (with or without aura) according to the criteria of the International Headache Society.
- Age at onset of migraine less than 45.0 years.
- Males and females between 18.0 and 65.0 years of age inclusive.
- Be willing and able to give written informed consent.
- For female patients, a negative pregnancy test
Key exclusion criteria (20 listed)
- Patients with ≥15 headache days (migraine and non-migraine headaches combined) per month.
- Patients who take analgesics for any reason ≥15 days a month or triptans ≥10 days a month.
- Non-migraine headaches on more than 6 days per month.
- Patients with schizophrenia.
- Patients prescribed more than one migraine prophylaxis treatment.
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 |
|---|---|---|
| BGC20-1531BGC20-1531 administered orally | Drug | BGC20-1531 200 mg, BGC20-1531 400mg |
| LactosePlacebo administered orally | Drug | Lactose |
Primary outcome
To evaluate the effect of BGC20-1531 on headache response, defined as a decrease of headache from severe or moderate to mild or none at 2 hours post-dose without the use of rescue medication.
Time frame: 2 hours
4 secondary outcomes
To evaluate the effect of BGC20-1531 on pain-freedom up to 48 hours post-dose without the use of rescue medication.
Time frame: Up to 48 hours
To evaluate the effect of BGC20-1531 on headache response up to 48 hours post-dose (without the use of rescue medication).
Time frame: Up to 48 hours
To evaluate the effect of BGC20-1531 on sustained headache relief and pain-freedom over a 24-hour and 48-hour period post-dose.
Time frame: Up to 48 hours
To evaluate the safety of BGC20-1531.
Time frame: Duration of the study
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2022.
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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 principal investigator
Danish Headache Center
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BGC20-1531 and Lactose in people with Migraine, run by Boston Scientific Corporation at 4 sites in 3 countries.
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 13 inclusion and 20 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: withdrawn, as of the sponsor's last update on 3 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Norway, Denmark, United Kingdom. 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 phase mean?
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 was withdrawn before enrolling participants, so there are no results.
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?
To evaluate the effect of BGC20-1531 on headache response, defined as a decrease of headache from severe or moderate to mild or none at 2 hours post-dose without the use of rescue medication. (time frame: 2 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 3 Jun 2022.