Migraine DisordersPhase 4NCT02191579
Efficacy and Safety Study of BOTOX® Compared to Topiramate for the Prevention of Chronic Migraine in Adults
A Phase 4 study testing onabotulinumtoxinA and Topiramate in people with Migraine Disorders, run by Allergan at 32 sites in United States.
Trial summary
This study will evaluate the efficacy, safety and tolerability of prophylactic (preventative) treatment with BOTOX® (onabotulinumtoxinA) compared to topiramate in adults with chronic migraine. 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?
- onabotulinumtoxinA and Topiramate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 282 participants
- Where
- 32 sitesUnited States
- Study dates
- 5 Aug 2014to 1 Sep 2017
- Phase
- Phase 4
- 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
Who may be able to join
- History of chronic migraine
- More than 15 headache days in a 28 day period (headaches that last more than 4 hours and/or require treatment with prescription medication).
Who cannot join
- Taking opioid-containing products for acute headache treatment more than 8 days during a 28-day period
- Previous treatment with botulinum toxin of any serotype for any reason
- Previous treatment with topiramate
- On a ketogenic diet (high in fat, low in carbohydrates)
- History of acute myopia or increased intraocular pressure
- Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis or any other significant disease that might interfere with neuromuscular function
- Acupuncture, transcutaneous electrical stimulation (TENS), cranial traction, dental splints for headache, or injection of anesthetics/steroids in the 4 weeks prior to screening.
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
United States32 sites
Dent Neurosciences Research Center Incorporated
Amherst, New York, 14226
Asheville Neurology Specialists PA
Asheville, North Carolina, 28806
The NeuroMedical Center
Baton Rouge, Louisiana, 70810
Parkinson's Disease and Movement Disorders Center of Boca Raton Inc
Boca Raton, Florida, 33486
Texas Neurology
Dallas, Texas, 75214
Denver Neurological Clinic
Denver, Colorado, 80210
Design Neuroscience Center
Doral, Florida, 33172
North County Neurology Associates
Encinitas, California, 92024
California Headache and Balance Center
Fresno, California, 93723
Headache Wellness Center
Greensboro, North Carolina, 27405
NW FL Clinical Research Group, LLC
Gulf Breeze, Florida, 32561
Allegiance Health
Jackson, Michigan, 49201
Newport Beach Clinical Research Associates, Inc.
Newport Beach, California, 92663
International Clinical Research Institute Inc
Overland Park, Kansas, 66210
Kansas City Bone and Joint Clinic
Overland Park, Kansas, 66211
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
St Joseph's Hospital Barrow Neurology Clinics
Phoenix, Arizona, 85013
Preferred Primary Care Physicians
Pittsburgh, Pennsylvania, 15236
Island Neurological Associates PC
Plainview, New York, 11803
Raleigh Neurology Associates PA
Raleigh, North Carolina, 27607
Renown Institute for Neurosciences
Reno, Nevada, 89502
Robbins Headache Clinic
Riverwoods, Illinois, 60015
Negroski, Sutherland & Hanes Neurology
Sarasota, Florida, 34239
Clinvest
Springfield, Missouri, 65807
Mercy Health Research
St Louis, Missouri, 63141
Ki Health Partners LLC DBA New England Institute for Neurology and Headache
Stamford, Connecticut, 06905
Puget Sound Neurology
Tacoma, Washington, 98409
Montefiore Headache Center
The Bronx, New York, 10461
MedVadis Research Corporation
Watertown, Massachusetts, 02472
Neurology Research Institute at Palm Beach Neurology
West Palm Beach, Florida, 33407
New England Regional Headache Center Inc
Worcester, Massachusetts, 01605
Main Line Health Lankenau Hospital
Wynnewood, Pennsylvania, 19096
About this study
Official title: A Multicenter, Prospective, Randomized, Open-label Study to Compare the Efficacy, Safety, and Tolerability of BOTOX® and Topiramate for Headache Prophylaxis in Adults With Chronic Migraine
This study will evaluate the efficacy, safety and tolerability of prophylactic (preventative) treatment with BOTOX® (onabotulinumtoxinA) compared to topiramate in adults with chronic migraine.
- Conditions
- Migraine Disorders
- Being tested
- onabotulinumtoxinA, Topiramate
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
onabotulinumtoxinABiological
Also called BOTOX®, botulinum toxin Type A
155U onabotulinumtoxinA (BOTOX®) total dose per treatment by intramuscular injection every 12 weeks.
TopiramateDrug
Also called Topamax®
Topiramate up to a maximum oral dose of 100 mg/day.
| Study group | Role | What they receive |
|---|---|---|
| BOTOX® | Active comparator | 155U onabotulinumtoxinA (BOTOX®) total dose per treatment by intramuscular injection every 12 weeks for up to 3 treatments. Receives: Biological: onabotulinumtoxinA |
| Topiramate | Active comparator | Topiramate starting at a daily oral dose of 25 mg/day titrated up to a maximum dose of 100 mg/day for 36 weeks. Participants who discontinue topiramate are eligible to receive treatment with BOTOX®. Receives: Drug: Topiramate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With a ≥ 50% Decrease From Baseline in the Frequency of Headache Days
Participants recorded their headaches in a daily e-diary. A headache day was defined as a calendar day (00:00 to 23:59) with 4 or more hours of headache and/or headache of any duration with the use of migraine-specific acute headache medication(s). The number of headache days over the 28-day period was counted. The percentage of participants with a ≥ 50% decrease in headache days in the 28-day period prior to Week 32 relative to Baseline (28-day period prior to Day 1) is reported.
Measured: Baseline (First 28 days from Screening) to the last 28-day period ending with Week 32
Secondary outcomes (3)
Change From Baseline in the Frequency of Headache Days Per 28-day Period
Participants recorded their headaches in a daily e-diary. A headache day was defined as a calendar day (00:00 to 23:59) with 4 or more hours of headache and/or headache of any duration with the use of migraine-specific acute headache medication(s). The number of headache days over the 28-day period was counted. A negative change from Baseline (less headache days) indicates improvement.
Measured: Baseline (First 28 days from Screening) to the last 28-day period ending with Week 32
Change From Baseline in Headache Impact Test (HIT-6) Total Score
The HIT-6 is a valid disease-targeted measure used to assess the impact of headaches, comprised of 6 items that assess pain, role functioning, social functioning, cognitive functioning, vitality, and psychological distress. A total score is created by summingacross all items, and ranges from 36 (no impact) to 78 (severe impact) reflecting a "best to worst" scoring.
A negative change from Baseline (a lower score) indicates improvement.
Measured: Baseline (Day 1) to the last 28-day period ending with Week 30
Percentage of Participants With a ≥ 70% Decrease From Baseline in the Frequency of Headache Days
Participants recorded their headaches in a daily e-diary. A headache day was defined as a calendar day (00:00 to 23:59) with 4 or more hours of headache and/or headache of any duration with the use of migraine-specific acute headache medication(s). The number of headache days over the 28-day period was counted. The percentage of participants with a ≥ 70% decrease in headache days in the 28-day period prior to Week 32 relative to Baseline (28-day period prior to Day 1) is reported.
Measured: Baseline (First 28 days from Screening) to the last 28-day period ending with Week 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2014 (estimated)
- Study start5 Aug 2014
- Primary completion9 May 2017
- Study completion1 Sep 2017
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.
- Publications (2)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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Esther Jo, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02191579
- Sponsor's protocol ID
- GMA-US-NEU-0206
- Other IDs
- FORWARD
- Status last verified
- Apr 2018
- First submitted
- 14 Jul 2014
- Last updated
- 7 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Blumenfeld AM, Patel AT, Turner IM, Mullin KB, Manack Adams A, Rothrock JF. Patient-Reported Outcomes from a 1-Year, Real-World, Head-to-Head Comparison of OnabotulinumtoxinA and Topiramate for Headache Prevention in Adults With Chronic Migraine. J Prim Care Community Health. 2020 Jan-Dec;11:2150132720959936. doi: 10.1177/2150132720959936.
PubMed 32985341Rothrock JF, Adams AM, Lipton RB, Silberstein SD, Jo E, Zhao X, Blumenfeld AM; FORWARD Study investigative group. FORWARD Study: Evaluating the Comparative Effectiveness of OnabotulinumtoxinA and Topiramate for Headache Prevention in Adults With Chronic Migraine. Headache. 2019 Nov;59(10):1700-1713. doi: 10.1111/head.13653. Epub 2019 Sep 26.
PubMed 31559634
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Randomized, Open-label Study to Compare the Efficacy, Safety, and Tolerability of BOTOX® and Topiramate for Headache Prophylaxis in Adults With Chronic Migraine
- ClinicalTrials.gov ID
- NCT02191579
- Acronym / sponsor ID
- GMA-US-NEU-0206
- Conditions
- Migraine Disorders
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 5 Aug 2014 (actual)
- Primary completion
- 9 May 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 16 Jul 2014 (estimated)
- Results
- Posted 7 Jun 2018
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 efficacy, safety and tolerability of prophylactic (preventative) treatment with BOTOX® (onabotulinumtoxinA) compared to topiramate in adults with chronic migraine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BOTOX® | Active comparator | Biological: onabotulinumtoxinA155U onabotulinumtoxinA (BOTOX®) total dose per treatment by intramuscular injection every 12 weeks for up to 3 treatments. |
| Topiramate | Active comparator | Drug: TopiramateTopiramate starting at a daily oral dose of 25 mg/day titrated up to a maximum dose of 100 mg/day for 36 weeks. Participants who discontinue topiramate are eligible to receive treatment with BOTOX®. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- History of chronic migraine
- More than 15 headache days in a 28 day period (headaches that last more than 4 hours and/or require treatment with prescription medication).
Key exclusion criteria (7 listed)
- Taking opioid-containing products for acute headache treatment more than 8 days during a 28-day period
- Previous treatment with botulinum toxin of any serotype for any reason
- Previous treatment with topiramate
- On a ketogenic diet (high in fat, low in carbohydrates)
- History of acute myopia or increased intraocular pressure
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: BOTOX®, botulinum toxin Type A155U onabotulinumtoxinA (BOTOX®) total dose per treatment by intramuscular injection every 12 weeks. | Biological | BOTOX® |
| TopiramateAlso: Topamax®Topiramate up to a maximum oral dose of 100 mg/day. | Drug | Topiramate |
Primary outcome
Percentage of Participants With a ≥ 50% Decrease From Baseline in the Frequency of Headache Days
Time frame: Baseline (First 28 days from Screening) to the last 28-day period ending with Week 32
Participants recorded their headaches in a daily e-diary. A headache day was defined as a calendar day (00:00 to 23:59) with 4 or more hours of headache and/or headache of any duration with the use of migraine-specific acute headache medication(s). The number of headache days over the 28-day period was counted. The percentage of participants with a ≥ 50% decrease in headache days in the 28-day period prior to Week 32 relative to Baseline (28-day period prior to Day 1) is reported.
3 secondary outcomes
Change From Baseline in the Frequency of Headache Days Per 28-day Period
Time frame: Baseline (First 28 days from Screening) to the last 28-day period ending with Week 32
Change From Baseline in Headache Impact Test (HIT-6) Total Score
Time frame: Baseline (Day 1) to the last 28-day period ending with Week 30
Percentage of Participants With a ≥ 70% Decrease From Baseline in the Frequency of Headache Days
Time frame: Baseline (First 28 days from Screening) to the last 28-day period ending with Week 32
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32985341Blumenfeld AM, Patel AT, Turner IM, Mullin KB, Manack Adams A, Rothrock JF. Patient-Reported Outcomes from a 1-Year, Real-World, Head-to-Head Comparison of OnabotulinumtoxinA and Topiramate for Headache Prevention in Adults With Chronic Migraine. J Prim Care Community Health. 2020 Jan-Dec;11:2150132720959936. doi: 10.1177/2150132720959936.
- Derived from this study: PubMed 31559634Rothrock JF, Adams AM, Lipton RB, Silberstein SD, Jo E, Zhao X, Blumenfeld AM; FORWARD Study investigative group. FORWARD Study: Evaluating the Comparative Effectiveness of OnabotulinumtoxinA and Topiramate for Headache Prevention in Adults With Chronic Migraine. Headache. 2019 Nov;59(10):1700-1713. doi: 10.1111/head.13653. Epub 2019 Sep 26.
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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.
Esther Jo study director
Allergan
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing onabotulinumtoxinA and Topiramate in people with Migraine Disorders, run by Allergan at 32 sites 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 7 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 7 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jun 2018). 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?
Percentage of Participants With a ≥ 50% Decrease From Baseline in the Frequency of Headache Days (time frame: Baseline (First 28 days from Screening) to the last 28-day period ending with Week 32). 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 NCT02191579, which also lists 2 linked publications.
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 7 Jun 2018.