Migraine DisordersNCT01976611
Safety and Efficacy of Botulinum Toxin Type A (BOTOX®) to Treat Chronic Migraine in Korea
An observational study of Migraine Disorders and Headache, run by Allergan at 1 site in South Korea.
Trial summary
This study is a Post-Marketing Surveillance study in Korea to evaluate the safety and efficacy of botulinum toxin Type A to treat Chronic Migraine in clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine Disorders, Headache
- What is being tested?
- botulinum toxin Type A
- How many people
- 402 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2012to Feb 2015
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated with botulinum toxin Type A for chronic migraine in clinical practice.
Who may be able to join
- Patients treated with botulinum toxin Type A for chronic migraine in clinical practice.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
About this study
This study is a Post-Marketing Surveillance study in Korea to evaluate the safety and efficacy of botulinum toxin Type A to treat Chronic Migraine in clinical practice.
- Conditions
- Migraine Disorders, Headache
- Being tested
- botulinum toxin Type A
- 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.
botulinum toxin Type ABiological
Botulinum toxin Type A treatment for chronic migraine as per local standard of care in clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| BOTOX® | Patients who receive botulinum toxin Type A (BOTOX®) treatment for chronic migraine as per local standard of care in clinical practice. Receives: Biological: botulinum toxin Type A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events and Adverse Drug Reactions
Measured: 4 Years
Headache Impact Test-6 (HIT-6) Score Using a 5-Point Scale
Measured: 4 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2013 (estimated)
- Study startJun 2012
- Primary completionFeb 2015
- Study completionFeb 2015
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 402 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01976611
- Sponsor's protocol ID
- 191622-139
- Status last verified
- Apr 2015
- First submitted
- 30 Oct 2013
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Botulinum Toxin Type A (BOTOX®) to Treat Chronic Migraine in Korea
- ClinicalTrials.gov ID
- NCT01976611
- Acronym / sponsor ID
- 191622-139
- Conditions
- Migraine Disorders, Headache
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 402 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 6 Nov 2013 (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.
This study is a Post-Marketing Surveillance study in Korea to evaluate the safety and efficacy of botulinum toxin Type A to treat Chronic Migraine in clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BOTOX® | – | Biological: botulinum toxin Type APatients who receive botulinum toxin Type A (BOTOX®) treatment for chronic migraine as per local standard of care in clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated with botulinum toxin Type A for chronic migraine in clinical practice.
Key inclusion criteria (1 listed)
- Patients treated with botulinum toxin Type A for chronic migraine in clinical practice.
Key exclusion criteria (1 listed)
- None.
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 ABotulinum toxin Type A treatment for chronic migraine as per local standard of care in clinical practice. | Biological | BOTOX® |
Primary outcome
Number of Participants with Adverse Events and Adverse Drug Reactions
Time frame: 4 Years
Headache Impact Test-6 (HIT-6) Score Using a 5-Point Scale
Time frame: 4 Years
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 8 Apr 2015.
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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.
Medical Director study director
Allergan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine Disorders and Headache, run by Allergan at 1 site in South Korea.
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 1 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 8 Apr 2015. 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 South Korea. 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.
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?
Number of Participants with Adverse Events and Adverse Drug Reactions (time frame: 4 Years). The study lists 2 primary outcomes in all. 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 8 Apr 2015.