Migraine DisordersPREDICTNCT02502123
Patient Reported Outcomes in Patients With Chronic Migraine Treated With BOTOX®
An observational study of Migraine Disorders, run by Allergan at 15 sites in Canada.
Trial summary
This study will prospectively assess long term heath related quality of life in chronic migraine patients currently being treated with OnabotulinumtoxinA for injection (BOTOX®) as standard of care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine Disorders
- How many people
- 215 participants
- Where
- 15 sitesCanada
- Study dates
- 2 Jul 2015to 29 Jan 2019
- 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 with chronic migraine treated with BOTOX® as standard of care.
Who may be able to join
- -Patients with chronic migraine eligible to receive treatment with onabotulinumtoxinA (BOTOX®) as standard of care.
Who cannot join
- Diagnosis of hemiplegic migraine, basilar migraine, ophthalmoplegic migraine or migrainous infarction, chronic tension-type headache, hypnic headache, hemicrania continua or new daily persistent headache.
- Patient who is currently taking or planning on taking opioid-containing products, barbiturates or combination for acute headache or pain condition.
- Treatment with any other botulinum toxin product for any condition within 3 months of the screening visit.
- Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis or any other significant disease that might interfere with neuromuscular function.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Canada15 sites
Bayside Medical Centre
Brentwood Bay, British Columbia, V8M 1P6
Foothills Medical Centre
Calgary, Alberta, T2N 2T9
Hys Medical Centre
Edmonton, Alberta, T5H 4B9
Hamilton Headache Clinic
Hamilton, Ontario, L8N 1Y2
Jeff Oyler
Kamloops, British Columbia, V2C 5T1
The Shapero Markham Headache and Pain Treatment Centre
Markham, Ontario, L3R 9X3
Pain Care Clinics
Mississauga, Ontario, L5N 6B8
Centre de traitement neurologique
Monthreal, Quebec, H2W 1T9
Clinic Greene Avenue
Montreal, Quebec, H3Z 2A4
Toronto Headache & Pain Centre
North York, Ontario, M3B 1X7
Hany Demian
Oakville, Ontario, L6K 3Y6
Nepean Medical Centre
Ottawa, Ontario, K2G 6E2
Dhawan Medical Corporation Medical Clinic
Vancouver, British Columbia, V5Z 4E1
May Ong-Lam
Vancouver, British Columbia, V6Z 2E8
Island Neurology
Victoria, British Columbia, V9B 1W3
About this study
Official title: Multi-Centre, Prospective, Observational Study of Patient Reported Outcomes in Patients Diagnosed With Chronic Migraine and Treated With OnabotulinumtoxinA for Injection (BOTOX®) (PREDICT)
This study will prospectively assess long term heath related quality of life in chronic migraine patients currently being treated with OnabotulinumtoxinA for injection (BOTOX®) as standard of care.
- Conditions
- Migraine Disorders
- Being tested
- No Intervention
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
No intervention was administered in this study.
| Study group | Role | What they receive |
|---|---|---|
| OnabotulinumtoxinA (BOTOX®) | Patients diagnosed with chronic migraine headache treated with BOTOX® as standard of care in clinical practice. No intervention was administered in this study. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Migraine-Specific Quality of Life (MSQ) at Treatment 4 Using a 6-Item Questionnaire
Measured: Baseline, Treatment 4 (approximately 24 Weeks)
Secondary outcomes (9)
Change from Baseline in MSQ at Final Visit Using a 6-Item Questionnaire
Measured: Baseline, Final Visit (Up to 2 Years)
Clinician's Global Impression of Change Using a 7-Point Scale
Measured: Up to 2 Years
Healthcare Resource Utilization Before and After BOTOX® using a 9-Item Questionnaire
Measured: Baseline, Up to 2 Years
BOTOX® Treatment Regimen for Chronic Migraine
Measured: Up to 2 Years
Work Productivity and Activity Impairment Questionnaire: Specific Health Problem Before and After BOTOX® Consisting of 6-Items
Measured: Baseline, Up to 2 Years
Patient Global Assessment of Treatment Satisfaction with BOTOX® using a 3-Item Questionnaire
Measured: 2 Years
Change from Baseline in Beck Depression Inventory Scale at Final Visit Using a 21-Item Questionnaire
Measured: Baseline, Final Visit (Up to 2 Years)
Reasons Why Treatment with BOTOX® Stopped
Measured: Up to 2 Years
Headache Assessment from Patient Diary
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2015 (estimated)
- Study start2 Jul 2015
- Primary completion29 Jan 2019
- Study completion29 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Goran Davidoic, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02502123
- Sponsor's protocol ID
- GMA-CAN-NEU-0336
- Acronym
- PREDICT
- Status last verified
- Apr 2019
- First submitted
- 16 Jul 2015
- Last updated
- 5 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Boudreau G, Finkelstein I, Graboski C, Ong M, Christie S, Sommer K, Bhogal M, Davidovic G, Becker WJ. OnabotulinumtoxinA Improves Quality of Life in Chronic Migraine: The PREDICT Study - CORRIGENDUM. Can J Neurol Sci. 2024 Jan;51(1):149. doi: 10.1017/cjn.2023.317. Epub 2023 Dec 18. No abstract available.
PubMed 38105013
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Centre, Prospective, Observational Study of Patient Reported Outcomes in Patients Diagnosed With Chronic Migraine and Treated With OnabotulinumtoxinA for Injection (BOTOX®) (PREDICT)
- ClinicalTrials.gov ID
- NCT02502123
- Acronym / sponsor ID
- PREDICT / GMA-CAN-NEU-0336
- Conditions
- Migraine Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 2 Jul 2015 (actual)
- Primary completion
- 29 Jan 2019 (actual)
- Study completion
- 29 Jan 2019 (actual)
- First posted
- 20 Jul 2015 (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 will prospectively assess long term heath related quality of life in chronic migraine patients currently being treated with OnabotulinumtoxinA for injection (BOTOX®) as standard of care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OnabotulinumtoxinA (BOTOX®) | – | Other: No InterventionPatients diagnosed with chronic migraine headache treated with BOTOX® as standard of care in clinical practice. No intervention was administered in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic migraine treated with BOTOX® as standard of care.
Key inclusion criteria (1 listed)
- -Patients with chronic migraine eligible to receive treatment with onabotulinumtoxinA (BOTOX®) as standard of care.
Key exclusion criteria (4 listed)
- Diagnosis of hemiplegic migraine, basilar migraine, ophthalmoplegic migraine or migrainous infarction, chronic tension-type headache, hypnic headache, hemicrania continua or new daily persistent headache.
- Patient who is currently taking or planning on taking opioid-containing products, barbiturates or combination for acute headache or pain condition.
- Treatment with any other botulinum toxin product for any condition within 3 months of the screening visit.
- Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis or any other significant disease that might interfere with neuromuscular function.
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 |
|---|---|---|
| No InterventionNo intervention was administered in this study. | Other | OnabotulinumtoxinA (BOTOX®) |
Primary outcome
Change from Baseline in Migraine-Specific Quality of Life (MSQ) at Treatment 4 Using a 6-Item Questionnaire
Time frame: Baseline, Treatment 4 (approximately 24 Weeks)
9 secondary outcomes
Change from Baseline in MSQ at Final Visit Using a 6-Item Questionnaire
Time frame: Baseline, Final Visit (Up to 2 Years)
Clinician's Global Impression of Change Using a 7-Point Scale
Time frame: Up to 2 Years
Healthcare Resource Utilization Before and After BOTOX® using a 9-Item Questionnaire
Time frame: Baseline, Up to 2 Years
BOTOX® Treatment Regimen for Chronic Migraine
Time frame: Up to 2 Years
Work Productivity and Activity Impairment Questionnaire: Specific Health Problem Before and After BOTOX® Consisting of 6-Items
Time frame: Baseline, Up to 2 Years
Patient Global Assessment of Treatment Satisfaction with BOTOX® using a 3-Item Questionnaire
Time frame: 2 Years
Change from Baseline in Beck Depression Inventory Scale at Final Visit Using a 21-Item Questionnaire
Time frame: Baseline, Final Visit (Up to 2 Years)
Reasons Why Treatment with BOTOX® Stopped
Time frame: Up to 2 Years
Headache Assessment from Patient Diary
Time frame: 2 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 5 Apr 2019.
- Derived from this study: PubMed 38105013Boudreau G, Finkelstein I, Graboski C, Ong M, Christie S, Sommer K, Bhogal M, Davidovic G, Becker WJ. OnabotulinumtoxinA Improves Quality of Life in Chronic Migraine: The PREDICT Study - CORRIGENDUM. Can J Neurol Sci. 2024 Jan;51(1):149. doi: 10.1017/cjn.2023.317. Epub 2023 Dec 18. No abstract available.
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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.
Goran Davidoic study director
Allergan
15 sites 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, run by Allergan at 15 sites in Canada.
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 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 5 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Canada. 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?
Change from Baseline in Migraine-Specific Quality of Life (MSQ) at Treatment 4 Using a 6-Item Questionnaire (time frame: Baseline, Treatment 4 (approximately 24 Weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02502123, which also lists 1 linked publication.
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 5 Apr 2019.