Chronic Migraine, HeadachesNCT01749410
A Retrospective Study to Evaluate the Effectiveness and Benefit of onabotulinumtoxinA in Patients With Chronic Migraines
An observational study of Chronic Migraine, Headaches, run by Allergan at 1 site in United States.
Trial summary
This study will evaluate the effectiveness and benefit of treatment with onabotulinumtoxinA in Chronic Migraine patients who have received a minimum of 7 treatment cycles. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Migraine, Headaches
- What is being tested?
- onabotulinumtoxinA
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to May 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: Participants who previously received at least 7 treatment cycles of onabotulinumtoxinA as Treatment for Chronic Migraine.
Who may be able to join
- 15 or more headache days over a 30 day period
- A minimum of 7 treatment cycles with onabotulinumtoxinA
Who cannot join
- Any treatment cycle dose of onabotulinumtoxinA greater than 200 units
Trial locations and contacts
1 site in 1 country.
About this study
This study will evaluate the effectiveness and benefit of treatment with onabotulinumtoxinA in Chronic Migraine patients who have received a minimum of 7 treatment cycles.
- Conditions
- Chronic Migraine, Headaches
- Being tested
- onabotulinumtoxinA
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
onabotulinumtoxinABiological
Also called Botulinum Toxin Type A, BOTOX®
Previous treatment with onabotulinumtoxinA for Chronic Migraine.
| Study group | Role | What they receive |
|---|---|---|
| All participants | Previous treatment with onabotulinumtoxinA for Chronic Migraine based on retrospective medical record review. Receives: Biological: onabotulinumtoxinA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the Number of Headache Days
The mean number of headache days was counted as the number of headache days occurring during the 30 day period ending with treatment cycle 7. Each treatment cycle was administered approximately every 12 weeks.
Measured: Treatment Cycle 7 (approximately 1.5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2012 (estimated)
- Study startMay 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Migraine, HeadachesStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 33 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
- NCT01749410
- Sponsor's protocol ID
- GMA-BTX-CM-12-491
- Status last verified
- Aug 2015
- First submitted
- 12 Dec 2012
- Last updated
- 10 Sep 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study to Evaluate the Effectiveness and Benefit of onabotulinumtoxinA in Patients With Chronic Migraines
- ClinicalTrials.gov ID
- NCT01749410
- Acronym / sponsor ID
- GMA-BTX-CM-12-491
- Conditions
- Chronic Migraine, Headaches
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 13 Dec 2012 (estimated)
- Results
- Posted 10 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the effectiveness and benefit of treatment with onabotulinumtoxinA in Chronic Migraine patients who have received a minimum of 7 treatment cycles.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | – | Biological: onabotulinumtoxinAPrevious treatment with onabotulinumtoxinA for Chronic Migraine based on retrospective medical record review. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who previously received at least 7 treatment cycles of onabotulinumtoxinA as Treatment for Chronic Migraine.
Key inclusion criteria (2 listed)
- 15 or more headache days over a 30 day period
- A minimum of 7 treatment cycles with onabotulinumtoxinA
Key exclusion criteria (1 listed)
- Any treatment cycle dose of onabotulinumtoxinA greater than 200 units
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 |
|---|---|---|
| onabotulinumtoxinAAlso: Botulinum Toxin Type A, BOTOX®Previous treatment with onabotulinumtoxinA for Chronic Migraine. | Biological | All participants |
Primary outcome
Change From Baseline in the Number of Headache Days
Time frame: Treatment Cycle 7 (approximately 1.5 years)
The mean number of headache days was counted as the number of headache days occurring during the 30 day period ending with treatment cycle 7. Each treatment cycle was administered approximately every 12 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Chronic Migraine, Headaches, run by Allergan at 1 site in United States.
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 2 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 10 Sep 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 United States. 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?
Yes. Results are posted in the registry (first posted 10 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in the Number of Headache Days (time frame: Treatment Cycle 7 (approximately 1.5 years)). 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 10 Sep 2015.