Migraine DisordersPhase 2NCT00751803
BI 44370 TA in Acute Migraine Attack
A Phase 2 study testing BI 44370 TA Low Dose, Eletriptan and BI 44370 TA Medium Dose in people with Migraine Disorders, run by Boehringer Ingelheim at 52 sites in 9 countries.
Trial summary
The objective of this trial is to assess the safety, tolerability, and efficacy of three doses of BI 44370 TA in the treatment of patients with an acute migraine attack and headache pain of moderate or severe intensity, compared to placebo and an active comparator. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine Disorders
- What is being tested?
- BI 44370 TA Low Dose, Eletriptan and BI 44370 TA Medium Dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 416 participants
- Where
- 52 sitesin 9 countries
- Study dates
- Aug 2008to May 2009
- 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
- Adult migraine patients with or without aura, diagnosed according to the ICH.
- Established migraine diagnosis greater than or equal to 1 year.
- Age at first migraine onset latest at 50 years of age.
- Medical history of migraine with headache of moderate to severe intensity and migraine frequency of 2-8 times/ month.
- Patient has provided written informed consent in accordance with ICH-GCP and local legislation.
Who cannot join
- History of hemiplegic, ophthalmoplegic or basilar migraine, or cluster headache.
- History of treatment-resistant migraine attacks.
- Other pain syndromes possibly interfering with study assessment or use of any pain medication > 10 days / month.
- Use of migraine and other restricted medication, or other restrictions as per protocol.
- Pregnancy or breast-feeding. Female of childbearing potential who do not use contraception.
- Clinically significant cardiovascular, peripheral vascular, hepatic, respiratory, haematological, gastrointestinal, renal, metabolic, immunological, hormonal, neurological and psychiatric disorders.
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- Patients in whom unrecognised coronary artery disease is likely, or who are at risk of coronary artery disease indicated by the presence of risk factors.
- Persistent liver enzyme elevation such as ALT, AST or AP > 2x ULN.
- Known history of HIV, or history of cancer within the last 5 years.
- DSM-IV-defined-history of substance abuse or dependence within the past 6 months, excluding nicotine and caffeine, but including alcohol or benzodiazepines.
Trial locations and contacts
52 sites in 9 countries.
52 sites in 9 countries
France10 sites
1246.4.3307A Boehringer Ingelheim Investigational Site
Clermont-Ferrand
1246.4.3307B Boehringer Ingelheim Investigational Site
Clermont-Ferrand
1246.4.3303A Boehringer Ingelheim Investigational Site
Lille
1246.4.3301A Boehringer Ingelheim Investigational Site
Nice
1246.4.3301B Boehringer Ingelheim Investigational Site
Nice
1246.4.3305B Boehringer Ingelheim Investigational Site
Paris
1246.4.3304A Boehringer Ingelheim Investigational Site
Rouen
1246.4.3304B Boehringer Ingelheim Investigational Site
Rouen
1246.4.3302A Boehringer Ingelheim Investigational Site
Toulouse
1246.4.3302B Boehringer Ingelheim Investigational Site
Toulouse
Germany10 sites
1246.4.49002 Boehringer Ingelheim Investigational Site
Berlin
1246.4.49003 Boehringer Ingelheim Investigational Site
Erkelenz
1246.4.49001 Boehringer Ingelheim Investigational Site
Essen
1246.4.49006 Boehringer Ingelheim Investigational Site
Göttingen
1246.4.49004 Boehringer Ingelheim Investigational Site
Grevenbroich
1246.4.49011 Boehringer Ingelheim Investigational Site
Hüttenberg
1246.4.49007 Boehringer Ingelheim Investigational Site
Koenigstein Im Taurus
1246.4.49008 Boehringer Ingelheim Investigational Site
Munich
1246.4.49009 Boehringer Ingelheim Investigational Site
Munich
1246.4.49010 Boehringer Ingelheim Investigational Site
Münster
Belgium8 sites
1246.4.32004 Boehringer Ingelheim Investigational Site
Antwerp
1246.4.32005 Boehringer Ingelheim Investigational Site
Brussels
1246.4.32006 Boehringer Ingelheim Investigational Site
Charleroi
1246.4.32001 Boehringer Ingelheim Investigational Site
Ghent
1246.4.32002 Boehringer Ingelheim Investigational Site
Hasselt
1246.4.32009 Boehringer Ingelheim Investigational Site
Leuven
1246.4.32007 Boehringer Ingelheim Investigational Site
Liège
1246.4.32008 Boehringer Ingelheim Investigational Site
Montegnée
Italy6 sites
1246.4.39005 Boehringer Ingelheim Investigational Site
Bologna
1246.4.39006 Boehringer Ingelheim Investigational Site
Catania
1246.4.39001 Boehringer Ingelheim Investigational Site
Milan
1246.4.39004 Boehringer Ingelheim Investigational Site
Milan
1246.4.39003 Boehringer Ingelheim Investigational Site
Roma
1246.4.39002 Boehringer Ingelheim Investigational Site
Torino
Netherlands6 sites
1246.4.31001 Boehringer Ingelheim Investigational Site
's-Hertogenbosch
1246.4.31004 Boehringer Ingelheim Investigational Site
Amsterdam
1246.4.31003 Boehringer Ingelheim Investigational Site
Blaricum
1246.4.31002 Boehringer Ingelheim Investigational Site
Breda
1246.4.31005 Boehringer Ingelheim Investigational Site
Nijmegen
1246.4.31006 Boehringer Ingelheim Investigational Site
Zwolle
Sweden4 sites
1246.4.46001 Boehringer Ingelheim Investigational Site
Gothenburg
1246.4.46004 Boehringer Ingelheim Investigational Site
Linköping
1246.4.46005 Boehringer Ingelheim Investigational Site
Stockholm
1246.4.46002 Boehringer Ingelheim Investigational Site
Vällingby
United Kingdom4 sites
1246.4.44013 Boehringer Ingelheim Investigational Site
Liverpool
1246.4.44001 Boehringer Ingelheim Investigational Site
Oxford
1246.4.44003 Boehringer Ingelheim Investigational Site
Plymouth
1246.4.44007 Boehringer Ingelheim Investigational Site
Whitechapel, London
Spain3 sites
1246.4.34002 Boehringer Ingelheim Investigational Site
Barcelona
1246.4.34005 Boehringer Ingelheim Investigational Site
Santiago de Compostela
1246.4.34001 Boehringer Ingelheim Investigational Site
Valencia
El Salvador1 site
1246.4.34004 Boehringer Ingelheim Investigational Site
Oviedo
About this study
Official title: A Randomised, Double-blind, Placebo- and Active Comparator-controlled, Five Parallel Groups Study to Investigate the Efficacy and Safety of BI 44370 TA (50 mg, 200 mg, and 400 mg) Administered Orally Once During an Acute Migraine Attack of Moderate or Severe Intensity
The objective of this trial is to assess the safety, tolerability, and efficacy of three doses of BI 44370 TA in the treatment of patients with an acute migraine attack and headache pain of moderate or severe intensity, compared to placebo and an active comparator.
- Conditions
- Migraine Disorders
- Being tested
- BI 44370 TA Low Dose, Eletriptan, Placebo, BI 44370 TA Medium Dose
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 44370 TA Low DoseDrug
EletriptanDrug
PlaceboDrug
BI 44370 TA Medium DoseDrug
| Study group | Role | What they receive |
|---|---|---|
| BI 44370 TA Low Dose | Experimental | Not described Receives: Drug: BI 44370 TA Low Dose; Drug: Placebo |
| BI 44370 TA Medium Dose | Experimental | Not described Receives: Drug: Placebo; Drug: BI 44370 TA Medium Dose |
| BI 44370 TA High Dose | Experimental | Not described Receives: Drug: Placebo; Drug: BI 44370 TA Medium Dose |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Eletriptan | Active comparator | Not described Receives: Drug: Eletriptan; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is a pain free response, defined as reduction of severe or moderate headache to no headache, 2 hours after dosing.
Measured: 2 hours
Secondary outcomes (15)
Pain-free response 0.5, 1, 1.5, 24 and 48 hours after dosing
Measured: up to 48 h
Pain relief, defined as reduction of severe or moderate headache to mild or no headache, 0.5, 1, 1.5, 2, 24 and 48 hours after dosing
Measured: up to 48 h
Sustained pain-free response, defined as reduction of severe or moderate headache to no headache 2 hours after dosing and remaining pain-free up to 24 and 48 hours after dosing
Measured: up to 48 h
Sustained pain relief response, defined as reduction of severe or moderate headache to mild or no headache 2 hours after dosing and no worsening up to 24 and 48 hours after dosing
Measured: up to 48 h
Intensity of headache at the time of intake of study medication, and 0.5, 1, 1.5, 2, 24 and 48 hours after dosing
Measured: up to 48 h
Relief of associated migraine symptoms (nausea, vomiting, photophobia, phonophobia) 0.5, 1, 1.5, 2, 24 and 48 hours after dosing
Measured: up to 48 h
Time to meaningful relief, defined by the patient as occurring when relief of pain and associated symptoms becomes meaningful, up to 2 h after dosing
Measured: up to 2 h
Global evaluation of medication by the patient evaluated 48 h after study drug intake
Measured: up to 48 h
Functional disability assessed by the patient measured at the time of intake of study medication, and 0.5, 1, 1.5, 2, 24 and 48 hours post dosing
Measured: up to 48 h
Time to and use of rescue medication within 24 and 48 hours
Measured: up to 48 h
Recurrence / relapse of headache during time-intervals of 2-24 and 2-48 hours post dosing
Measured: up to 48 h
Incidences of adverse events
Measured: up to 7 days
Changes from baseline in safety laboratory parameters
Measured: up to 7 days
Changes from baseline in vital sign parameters
Measured: up to 7 days
Withdrawals due to adverse events
Measured: up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2008 (estimated)
- Study startAug 2008
- Primary completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine DisordersStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe 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
- Parallel groups
- Enrolment
- 416 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00751803
- Sponsor's protocol ID
- 1246.4
- Other IDs
- EudraCT No : 2008-000079-31
- Status last verified
- Nov 2014
- First submitted
- 25 Aug 2008
- Last updated
- 24 Nov 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo- and Active Comparator-controlled, Five Parallel Groups Study to Investigate the Efficacy and Safety of BI 44370 TA (50 mg, 200 mg, and 400 mg) Administered Orally Once During an Acute Migraine Attack of Moderate or Severe Intensity
- ClinicalTrials.gov ID
- NCT00751803
- Acronym / sponsor ID
- 1246.4
- Conditions
- Migraine Disorders
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 416 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- May 2009 (actual)
- First posted
- 12 Sep 2008 (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 objective of this trial is to assess the safety, tolerability, and efficacy of three doses of BI 44370 TA in the treatment of patients with an acute migraine attack and headache pain of moderate or severe intensity, compared to placebo and an active comparator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| BI 44370 TA Low Dose | Experimental | Drug: BI 44370 TA Low Dose, Drug: Placebo |
| BI 44370 TA Medium Dose | Experimental | Drug: Placebo, Drug: BI 44370 TA Medium Dose |
| BI 44370 TA High Dose | Experimental | Drug: Placebo, Drug: BI 44370 TA Medium Dose |
| Placebo | Placebo comparator | Drug: Placebo |
| Eletriptan | Active comparator | Drug: Eletriptan, Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult migraine patients with or without aura, diagnosed according to the ICH.
- Established migraine diagnosis greater than or equal to 1 year.
- Age at first migraine onset latest at 50 years of age.
- Medical history of migraine with headache of moderate to severe intensity and migraine frequency of 2-8 times/ month.
- Patient has provided written informed consent in accordance with ICH-GCP and local legislation.
Key exclusion criteria (10 listed)
- History of hemiplegic, ophthalmoplegic or basilar migraine, or cluster headache.
- History of treatment-resistant migraine attacks.
- Other pain syndromes possibly interfering with study assessment or use of any pain medication > 10 days / month.
- Use of migraine and other restricted medication, or other restrictions as per protocol.
- Pregnancy or breast-feeding. Female of childbearing potential who do not use contraception.
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 |
|---|---|---|
| BI 44370 TA Low Dose | Drug | BI 44370 TA Low Dose |
| Eletriptan | Drug | Eletriptan |
| Placebo | Drug | BI 44370 TA High Dose, BI 44370 TA Low Dose, BI 44370 TA Medium Dose, Eletriptan, Placebo |
| BI 44370 TA Medium Dose | Drug | BI 44370 TA High Dose, BI 44370 TA Medium Dose |
Primary outcome
The primary endpoint is a pain free response, defined as reduction of severe or moderate headache to no headache, 2 hours after dosing.
Time frame: 2 hours
15 secondary outcomes
Pain-free response 0.5, 1, 1.5, 24 and 48 hours after dosing
Time frame: up to 48 h
Pain relief, defined as reduction of severe or moderate headache to mild or no headache, 0.5, 1, 1.5, 2, 24 and 48 hours after dosing
Time frame: up to 48 h
Sustained pain-free response, defined as reduction of severe or moderate headache to no headache 2 hours after dosing and remaining pain-free up to 24 and 48 hours after dosing
Time frame: up to 48 h
Sustained pain relief response, defined as reduction of severe or moderate headache to mild or no headache 2 hours after dosing and no worsening up to 24 and 48 hours after dosing
Time frame: up to 48 h
Intensity of headache at the time of intake of study medication, and 0.5, 1, 1.5, 2, 24 and 48 hours after dosing
Time frame: up to 48 h
Relief of associated migraine symptoms (nausea, vomiting, photophobia, phonophobia) 0.5, 1, 1.5, 2, 24 and 48 hours after dosing
Time frame: up to 48 h
Time to meaningful relief, defined by the patient as occurring when relief of pain and associated symptoms becomes meaningful, up to 2 h after dosing
Time frame: up to 2 h
Global evaluation of medication by the patient evaluated 48 h after study drug intake
Time frame: up to 48 h
Functional disability assessed by the patient measured at the time of intake of study medication, and 0.5, 1, 1.5, 2, 24 and 48 hours post dosing
Time frame: up to 48 h
Time to and use of rescue medication within 24 and 48 hours
Time frame: up to 48 h
Recurrence / relapse of headache during time-intervals of 2-24 and 2-48 hours post dosing
Time frame: up to 48 h
Incidences of adverse events
Time frame: up to 7 days
Changes from baseline in safety laboratory parameters
Time frame: up to 7 days
Changes from baseline in vital sign parameters
Time frame: up to 7 days
Withdrawals due to adverse events
Time frame: up to 7 days
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 24 Nov 2014.
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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.
Boehringer Ingelheim study chair
Boehringer Ingelheim
52 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BI 44370 TA Low Dose, Eletriptan and BI 44370 TA Medium Dose in people with Migraine Disorders, run by Boehringer Ingelheim at 52 sites in 9 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 5 inclusion and 10 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 24 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in France, Germany, Belgium, Italy, Netherlands and 4 more countries. 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 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?
The primary endpoint is a pain free response, defined as reduction of severe or moderate headache to no headache, 2 hours after dosing. (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 24 Nov 2014.