MigrainePhase 2NCT00301665
Efficacy and Safety Study of Dysport® Used for Migraine Prophylaxis
A Phase 2 study testing Botulinum toxin type A in people with Migraine, run by Ipsen at 9 sites in 3 countries.
Trial summary
The purpose of this study is to evaluate the efficacy of botulinum toxin type A (Dysport®) injections into pericranial muscles compared to placebo to prevent migraine attacks. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- Botulinum toxin type A
- How many people
- 138 participants
- Where
- 9 sitesin 3 countries
- Study dates
- Feb 2003to Mar 2005
- 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
- Patients having migraine without aura or with typical aura as defined by International Headache Society criteria
- Migraine attacks have been persisting for more than 1 year
- 2 to 6 migraine attacks per month of at least moderate severity over the 3 months preceding the pre-inclusion visit
- 2 to 6 migraine attacks of at least moderate severity during the screening period
Who cannot join
- Non-migraine headaches such as tension-type headaches
- Migraine with prolonged aura, familial hemiplegic migraine, basilar migraine, migraine aura without headache, migraine with acute onset aura, ophthalmoplegic migraine, retinal migraine, complications of migraine
- Onset of migraine is after age of 50
- Overuse of acute migraine medications (individuals who take medications for acute migraine more than 10 days per month) or have a history of drug or alcohol abuse
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
Poland4 sites
Medical Academy of Poznan
Poznan, 60-355
Air Force Institute of Aviation Medicine
Warsaw
City Hospital of Wolomin
Wołomin, 05-200
Voivodeship (Provincial) Specialist Hospital
Zgierz, 95-100
Czechia3 sites
St. Anne's Faculty Hospital
Brno, 65691
University Hospital Hradec Kralove
Hradec Králové, 50005
General Faculty Hospital
Prague, 120 00
Slovakia2 sites
Faculty Hospital Bratislava
Bratislava, 813 69
Faculty Hospital
Martin, 036 01
About this study
Official title: A Phase II, Multicentre, Randomised, Double-blind, Parallel Groups, Placebo Controlled Clinical Study of Efficacy and Safety of Dysport® for Migraine Prophylaxis
The purpose of this study is to evaluate the efficacy of botulinum toxin type A (Dysport®) injections into pericranial muscles compared to placebo to prevent migraine attacks.
- Conditions
- Migraine
- Being tested
- Botulinum toxin type A
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin type ABiological
Also called AbobotulinumtoxinA (Dysport®)
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant decrease of the number of migraine attacks with Dysport® compared to placebo.
Measured: 3 months
Secondary outcomes (4)
Reduction of the intensity of the migraine attacks.
Measured: 3 months
Reduction of duration of the migraine attacks.
Measured: 3 months
Reduction of migraine medication consumption.
Measured: 3 months
Improvement of quality of life.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2006 (estimated)
- Study startFeb 2003
- Study completionMar 2005
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 IpsenThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00301665
- Sponsor's protocol ID
- A-38-52120-715
- Status last verified
- Apr 2020
- First submitted
- 9 Mar 2006
- Last updated
- 24 Apr 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicentre, Randomised, Double-blind, Parallel Groups, Placebo Controlled Clinical Study of Efficacy and Safety of Dysport® for Migraine Prophylaxis
- ClinicalTrials.gov ID
- NCT00301665
- Acronym / sponsor ID
- A-38-52120-715
- Conditions
- Migraine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Feb 2003
- Study completion
- Mar 2005 (actual)
- First posted
- 13 Mar 2006 (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 evaluate the efficacy of botulinum toxin type A (Dysport®) injections into pericranial muscles compared to placebo to prevent migraine attacks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients having migraine without aura or with typical aura as defined by International Headache Society criteria
- Migraine attacks have been persisting for more than 1 year
- 2 to 6 migraine attacks per month of at least moderate severity over the 3 months preceding the pre-inclusion visit
- 2 to 6 migraine attacks of at least moderate severity during the screening period
Key exclusion criteria (4 listed)
- Non-migraine headaches such as tension-type headaches
- Migraine with prolonged aura, familial hemiplegic migraine, basilar migraine, migraine aura without headache, migraine with acute onset aura, ophthalmoplegic migraine, retinal migraine, complications of migraine
- Onset of migraine is after age of 50
- Overuse of acute migraine medications (individuals who take medications for acute migraine more than 10 days per month) or have a history of drug or alcohol 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 |
|---|---|---|
| Botulinum toxin type AAlso: AbobotulinumtoxinA (Dysport®) | Biological | – |
Primary outcome
Significant decrease of the number of migraine attacks with Dysport® compared to placebo.
Time frame: 3 months
4 secondary outcomes
Reduction of the intensity of the migraine attacks.
Time frame: 3 months
Reduction of duration of the migraine attacks.
Time frame: 3 months
Reduction of migraine medication consumption.
Time frame: 3 months
Improvement of quality of life.
Time frame: 3 months
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 Apr 2020.
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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.
Ipsen Medical Director study director
Ipsen
9 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 Botulinum toxin type A in people with Migraine, run by Ipsen at 9 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 4 inclusion and 4 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 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Poland, Czechia, Slovakia. 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. 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?
Significant decrease of the number of migraine attacks with Dysport® compared to placebo. (time frame: 3 months). 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 Apr 2020.