Chronic MigrainePhase 3NCT05598723
BOTOX® vs. XEOMIN® for Chronic Migraine
A Phase 3 study testing IncobotulinumtoxinA (XEOMIN®) and OnabotulinumtoxinA (BOTOX®) in people with Chronic Migraine, run by Naval Medical Center Camp Lejeune at 1 site in United States.
Trial summary
Chronic migraine (CM) is a disabling disorder that sidelines active duty personnel and diminishes their quality of life. It affects 1.3% to 2.4% of the general population. These numbers increase in active duty personnel, especially those returning from deployment, as well as in veterans. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Chronic Migraine
- What is being tested?
- IncobotulinumtoxinA (XEOMIN®) and OnabotulinumtoxinA (BOTOX®)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2023to 24 Aug 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between ages of 18-89
- 15 or more headaches days experienced per month lasting 4 hours or longer
- Department of Defense (DoD) Beneficiary/TriCare Eligible
- Failure, contraindication or intolerance to two migraine medications from two different classes.
- Able to provide informed consent and be able to read and write English.
- Able to read, comprehend, and complete the assessment and diary
- Women must provide a negative urine pregnancy test
Who cannot join
- Currently pregnant, breastfeeding, or planning to become pregnant
- Allergic to botulinum toxin or to any of the ingredients of the medication
- Has myasthenia gravis, amyotrophic lateral sclerosis, or Eaton Lambert syndrome, mitochondrial disease, fibromyalgia, any temporomandibular disfunction, or any other significant disease that might interfere with neuromuscular function.
- Uncontrolled epilepsy defined as more than 1 generalized seizure in any month within the 3 months prior to the day 0 visit
- Those on oral anticoagulation
- Previous botulinum toxin treatment on the cephalic/upper lumbar region within 6 months for any indication
Show all 11Show fewer
- Localized infections on face, neck or on antibiotics for areas in this region
- Unable to attend study follow up visits for any reason (i.e. Training, deployment, or PCS)
- Use of any prophylactic headache medication between -4 weeks and week 0 visits
- Any person taking chronic pain medication for a chronic indication
- Any diagnosed psychiatric condition which would prohibit a participant from completing the trial in its totality.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Naval Medical Center Camp Lejeune
Jacksonville, North Carolina, 28547
Keely Klaumann, BS, 910-226-2258, keely.c.klaumann.ctr@health.mil
About this study
Official title: A Randomized, Double-Blind Study on the Effect of OnabotulinumtoxinA (BOTOX®) vs. IncobotulinumtoxinA (XEOMIN®) Botulinum Toxin in Adults With Chronic Migraine
Chronic migraine (CM) is a disabling disorder that sidelines active duty personnel and diminishes their quality of life. It affects 1.3% to 2.4% of the general population. These numbers increase in active duty personnel, especially those returning from deployment, as well as in veterans. Furthermore, these numbers are 4-5 times higher in military members who experienced at least one mild traumatic brain injury. CM leads to impaired cognition and poor decision-making. These impairments on critical active duty tasks could have a significant impact on task readiness and military performance. Therefore, CM presents a challenge for the "return to duty" mission. Currently, onabotulinumtoxinA is the only FDA-approved prophylactic treatment for CM; however, this treatment requires refrigeration, to which there is little access for the forward-deployed members who have limited access to adequate storage for this treatment. Therefore, it is imperative to identify a CM treatment that does not require refrigeration. Furthermore, in light of the ongoing COVID-19 pandemic and resulting international shortages in critical medication production and delivery, it is imperative to identify more than one treatment option for the management of CM. In this study, we will test the efficacy of incobotulinumtoxinA, a neurotoxin that, unlike onabotulinumtoxinA, does not require refrigeration, but is an effective off-label alternative for the treatment of migraine. OnabotulinumtoxinA and incobotulinumtoxinA are comparable in strength, with a conversion ratio of 1:1.
Read the detailed description
One hundred and twenty-eight male and female active duty personnel, adult dependent and retiree patients from the Navy Medical Center at Camp Lejeune who meet the International Classification of Headache Disorders 3rd Edition (ICHD-3) criteria of ≥15 headache days per month lasting 4 hours or longer will participate in the trial. Subjects will be group-allocated randomly, 64 to onabotulinumtoxinA and 64 to incobotulinumtoxinA. Injections of either treatment will occur twice, 12 weeks apart, in the head and neck regions. The primary treatment efficacy measurement will be the mean change in headache days 12 to 24 weeks post-treatment. Participants will complete an electronic diary to report headache days, their severity, and adverse effects or unforeseen events. A baseline will be established four weeks prior to the first botulinumtoxinA (Botox or Xeomin) administration using the number of headache days and two questionnaires, Headache Impact Test-6 (HIT-6) and the Migraine Specific Quality (MSQ) Questionnaire, which assess headache impact and Health-Related Quality of Life (HRQOL), respectively. These questionnaires will also be administered at weeks 12 and 24 of the study. The baseline, 12-, and 24-week analysis will be performed using a time vs. treatment repeated measures analysis of variance for headache days. Secondary outcomes (total scores of both the HIT-6 and MSQ) will be analyzed similarly.
- Conditions
- Chronic Migraine
- Being tested
- IncobotulinumtoxinA (XEOMIN®), OnabotulinumtoxinA (BOTOX®)
- Keywords
- Botox, Xeomin, onabotulinumtoxinA, incobotulinumtoxinA, Botulinum Toxin, refrigeration, HIT-6
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IncobotulinumtoxinA (XEOMIN®)Drug
Also called Xeomin
IncobotulinumtoxinA (XEOMIN®) is injected into specific targets at two different time points. Changes in chronic migraine frequency and duration are recorded and compared.
OnabotulinumtoxinA (BOTOX®)Drug
Also called Botox
OnabotulinumtoxinA (BOTOX®) is injected into specific targets at two different time points. Changes in chronic migraine frequency and duration are recorded and compared.
| Study group | Role | What they receive |
|---|---|---|
| OnabotulinumtoxinA (BOTOX®) | Active comparator | OnabotulinumtoxinA (BOTOX®) Group: Administration consists of 31 injections (5 onabotulinumtoxinA (BOTOX®) units per injection, for a total of 155units) in the head and neck at two time points (12 weeks apart). Injection sites include the forehead, temples, back of the head, upper neck, and the junction of the shoulder and the neck. A very small (e.g., 30-gauge), very sharp needle will be used to perform the injections. Receives: Drug: OnabotulinumtoxinA (BOTOX®) |
| IncobotulinumtoxinA (XEOMIN®) | Experimental | IncobotulinumtoxinA (XEOMIN®) Group: Administration consists of 31 injections (5 incobotulinumtoxinA (XEOMIN®) units per injection, for a total of 155 units) in the head and neck at two time points (12 weeks apart). Injection sites include the forehead, temples, back of the head, upper neck, and the junction of the shoulder and the neck. A very small (e.g., 30-gauge), very sharp needle will be used to perform the injections. Receives: Drug: IncobotulinumtoxinA (XEOMIN®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache days per month
To compare the difference in headache days per month (incobotulinumtoxinA (XEOMIN®) relative to onabotulinumtoxinA (BOTOX®)) at the end of treatment period (24 weeks).
Measured: 24 weeks + Baseline
Secondary outcomes (2)
Differences in headache impact
Assessed using the Headache Impact Test-6 (HIT-6): mean change from baseline will be reported. HIT-6 score ranges between 36 and 78, with larger scores reflecting greater impact.
Measured: 24 weeks vs. Baseline
Differences in Health-Related Quality of Life
Assessed using the Migraine Specific Quality (MSQ) Questionnaire: mean change from baseline will be reported. MSQ score ranges between 0-100 scale, with higher scores signifying better health-related quality of life.
Measured: 24 weeks vs. Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start24 Feb 2023
- Primary completion24 Feb 2027 (estimated)
- Study completion24 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Chronic MigraineStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, double blind, prospective, parallel-group study (non-inferiority trial)
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Naval Medical Center Camp Lejeune
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jacqueline S Buckley, PharmD, Principal investigator, Naval Medical Center Camp Lejeune
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05598723
- Sponsor's protocol ID
- NMCCL.2022.0029
- Status last verified
- Jul 2026
- First submitted
- 25 Oct 2022
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Burstein R, Noseda R, Borsook D. Migraine: multiple processes, complex pathophysiology. J Neurosci. 2015 Apr 29;35(17):6619-29. doi: 10.1523/JNEUROSCI.0373-15.2015.
PubMed 25926442Sandrini G, De Icco R, Tassorelli C, Smania N, Tamburin S. Botulinum neurotoxin type A for the treatment of pain: not just in migraine and trigeminal neuralgia. J Headache Pain. 2017 Dec;18(1):38. doi: 10.1186/s10194-017-0744-z. Epub 2017 Mar 21.
PubMed 28324318May A, Schulte LH. Chronic migraine: risk factors, mechanisms and treatment. Nat Rev Neurol. 2016 Aug;12(8):455-64. doi: 10.1038/nrneurol.2016.93. Epub 2016 Jul 8.
PubMed 27389092Schwedt TJ. Chronic migraine. BMJ. 2014 Mar 24;348:g1416. doi: 10.1136/bmj.g1416.
PubMed 24662044Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013 Jul;33(9):629-808. doi: 10.1177/0333102413485658. No abstract available.
PubMed 23771276Do TP, Hvedstrup J, Schytz HW. Botulinum toxin: A review of the mode of action in migraine. Acta Neurol Scand. 2018 May;137(5):442-451. doi: 10.1111/ane.12906. Epub 2018 Feb 6.
PubMed 29405250Carruthers A, Carruthers J. Botulinum toxin products overview. Skin Therapy Lett. 2008 Jul-Aug;13(6):1-4.
PubMed 18806905Frevert J, Dressler D. Complexing proteins in botulinum toxin type A drugs: a help or a hindrance? Biologics. 2010 Dec 9;4:325-32. doi: 10.2147/BTT.S14902.
PubMed 21209727Aurora SK, Dodick DW, Turkel CC, DeGryse RE, Silberstein SD, Lipton RB, Diener HC, Brin MF; PREEMPT 1 Chronic Migraine Study Group. OnabotulinumtoxinA for treatment of chronic migraine: results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 1 trial. Cephalalgia. 2010 Jul;30(7):793-803. doi: 10.1177/0333102410364676. Epub 2010 Mar 17.
PubMed 20647170Diener HC, Dodick DW, Aurora SK, Turkel CC, DeGryse RE, Lipton RB, Silberstein SD, Brin MF; PREEMPT 2 Chronic Migraine Study Group. OnabotulinumtoxinA for treatment of chronic migraine: results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 2 trial. Cephalalgia. 2010 Jul;30(7):804-14. doi: 10.1177/0333102410364677. Epub 2010 Mar 17.
PubMed 20647171Rendas-Baum R, Bloudek LM, Maglinte GA, Varon SF. The psychometric properties of the Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ) in chronic migraine patients. Qual Life Res. 2013 Jun;22(5):1123-33. doi: 10.1007/s11136-012-0230-7. Epub 2012 Jul 15.
PubMed 22797868Ion I, Renard D, Le Floch A, De Verdal M, Bouly S, Wacongne A, Lozza A, Castelnovo G. Monocentric Prospective Study into the Sustained Effect of Incobotulinumtoxin A (XEOMIN(R)) Botulinum Toxin in Chronic Refractory Migraine. Toxins (Basel). 2018 Jun 1;10(6):221. doi: 10.3390/toxins10060221.
PubMed 29857565Kwong WJ, Pathak DS. Validation of the eleven-point pain scale in the measurement of migraine headache pain. Cephalalgia. 2007 Apr;27(4):336-42. doi: 10.1111/j.1468-2982.2007.01283.x.
PubMed 17376110Bagley CL, Rendas-Baum R, Maglinte GA, Yang M, Varon SF, Lee J, Kosinski M. Validating Migraine-Specific Quality of Life Questionnaire v2.1 in episodic and chronic migraine. Headache. 2012 Mar;52(3):409-21. doi: 10.1111/j.1526-4610.2011.01997.x. Epub 2011 Sep 19.
PubMed 21929662Wilderman I, Tallarigo D, Pugacheva-Zingerman O. A Qualitative Study to Explore Patient Perspectives of Prophylactic Treatment with OnabotulinumtoxinA for Chronic Migraine. Pain Ther. 2021 Dec;10(2):1523-1536. doi: 10.1007/s40122-021-00316-2. Epub 2021 Sep 14.
PubMed 34523107
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind Study on the Effect of OnabotulinumtoxinA (BOTOX®) vs. IncobotulinumtoxinA (XEOMIN®) Botulinum Toxin in Adults With Chronic Migraine
- ClinicalTrials.gov ID
- NCT05598723
- Acronym / sponsor ID
- NMCCL.2022.0029
- Conditions
- Chronic Migraine
- Keywords
- Botox, Xeomin, onabotulinumtoxinA, incobotulinumtoxinA, Botulinum Toxin, refrigeration, HIT-6
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Naval Medical Center Camp LejeuneUS federal agency
- Study start
- 24 Feb 2023 (actual)
- Primary completion
- 24 Feb 2027 (estimated)
- Study completion
- 24 Aug 2027 (estimated)
- First posted
- 28 Oct 2022 (actual)
- 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.
Chronic migraine (CM) is a disabling disorder that sidelines active duty personnel and diminishes their quality of life. It affects 1.3% to 2.4% of the general population. These numbers increase in active duty personnel, especially those returning from deployment, as well as in veterans. Furthermore, these numbers are 4-5 times higher in military members who experienced at least one mild traumatic brain injury. CM leads to impaired cognition and poor decision-making. These impairments on critical active duty tasks could have a significant impact on task readiness and military performance. Therefore, CM presents a challenge for the "return to duty" mission. Currently, onabotulinumtoxinA is the only FDA-approved prophylactic treatment for CM; however, this treatment requires refrigeration, to which there is little access for the forward-deployed members who have limited access to adequate storage for this treatment. Therefore, it is imperative to identify a CM treatment that does not require refrigeration. Furthermore, in light of the ongoing COVID-19 pandemic and resulting international shortages in critical medication production and delivery, it is imperative to identify more than one treatment option for the management of CM. In this study, we will test the efficacy of incobotulinumtoxinA, a neurotoxin that, unlike onabotulinumtoxinA, does not require refrigeration, but is an effective off-label alternative for the treatment of migraine. OnabotulinumtoxinA and incobotulinumtoxinA are comparable in strength, with a conversion ratio of 1:1.
Detailed description
One hundred and twenty-eight male and female active duty personnel, adult dependent and retiree patients from the Navy Medical Center at Camp Lejeune who meet the International Classification of Headache Disorders 3rd Edition (ICHD-3) criteria of ≥15 headache days per month lasting 4 hours or longer will participate in the trial. Subjects will be group-allocated randomly, 64 to onabotulinumtoxinA and 64 to incobotulinumtoxinA. Injections of either treatment will occur twice, 12 weeks apart, in the head and neck regions. The primary treatment efficacy measurement will be the mean change in headache days 12 to 24 weeks post-treatment. Participants will complete an electronic diary to report headache days, their severity, and adverse effects or unforeseen events. A baseline will be established four weeks prior to the first botulinumtoxinA (Botox or Xeomin) administration using the number of headache days and two questionnaires, Headache Impact Test-6 (HIT-6) and the Migraine Specific Quality (MSQ) Questionnaire, which assess headache impact and Health-Related Quality of Life (HRQOL), respectively. These questionnaires will also be administered at weeks 12 and 24 of the study. The baseline, 12-, and 24-week analysis will be performed using a time vs. treatment repeated measures analysis of variance for headache days. Secondary outcomes (total scores of both the HIT-6 and MSQ) will be analyzed similarly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- A randomized, double blind, prospective, parallel-group study (non-inferiority trial)
| Arm | Type | Receives |
|---|---|---|
| OnabotulinumtoxinA (BOTOX®) | Active comparator | Drug: OnabotulinumtoxinA (BOTOX®)OnabotulinumtoxinA (BOTOX®) Group: Administration consists of 31 injections (5 onabotulinumtoxinA (BOTOX®) units per injection, for a total of 155units) in the head and neck at two time points (12 weeks apart). Injection sites include the forehead, temples, back of the head, upper neck, and the junction of the shoulder and the neck. A very small (e.g., 30-gauge), very sharp needle will be used to perform the injections. |
| IncobotulinumtoxinA (XEOMIN®) | Experimental | Drug: IncobotulinumtoxinA (XEOMIN®)IncobotulinumtoxinA (XEOMIN®) Group: Administration consists of 31 injections (5 incobotulinumtoxinA (XEOMIN®) units per injection, for a total of 155 units) in the head and neck at two time points (12 weeks apart). Injection sites include the forehead, temples, back of the head, upper neck, and the junction of the shoulder and the neck. A very small (e.g., 30-gauge), very sharp needle will be used to perform the injections. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Between ages of 18-89
- 15 or more headaches days experienced per month lasting 4 hours or longer
- Department of Defense (DoD) Beneficiary/TriCare Eligible
- Failure, contraindication or intolerance to two migraine medications from two different classes.
- Able to provide informed consent and be able to read and write English.
Key exclusion criteria (11 listed)
- Currently pregnant, breastfeeding, or planning to become pregnant
- Allergic to botulinum toxin or to any of the ingredients of the medication
- Has myasthenia gravis, amyotrophic lateral sclerosis, or Eaton Lambert syndrome, mitochondrial disease, fibromyalgia, any temporomandibular disfunction, or any other significant disease that might interfere with neuromuscular function.
- Uncontrolled epilepsy defined as more than 1 generalized seizure in any month within the 3 months prior to the day 0 visit
- Those on oral anticoagulation
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 |
|---|---|---|
| IncobotulinumtoxinA (XEOMIN®)Also: XeominIncobotulinumtoxinA (XEOMIN®) is injected into specific targets at two different time points. Changes in chronic migraine frequency and duration are recorded and compared. | Drug | IncobotulinumtoxinA (XEOMIN®) |
| OnabotulinumtoxinA (BOTOX®)Also: BotoxOnabotulinumtoxinA (BOTOX®) is injected into specific targets at two different time points. Changes in chronic migraine frequency and duration are recorded and compared. | Drug | OnabotulinumtoxinA (BOTOX®) |
Primary outcome
Headache days per month
Time frame: 24 weeks + Baseline
To compare the difference in headache days per month (incobotulinumtoxinA (XEOMIN®) relative to onabotulinumtoxinA (BOTOX®)) at the end of treatment period (24 weeks).
2 secondary outcomes
Differences in headache impact
Time frame: 24 weeks vs. Baseline
Differences in Health-Related Quality of Life
Time frame: 24 weeks vs. Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Background: PubMed 25926442Burstein R, Noseda R, Borsook D. Migraine: multiple processes, complex pathophysiology. J Neurosci. 2015 Apr 29;35(17):6619-29. doi: 10.1523/JNEUROSCI.0373-15.2015.
- Background: PubMed 28324318Sandrini G, De Icco R, Tassorelli C, Smania N, Tamburin S. Botulinum neurotoxin type A for the treatment of pain: not just in migraine and trigeminal neuralgia. J Headache Pain. 2017 Dec;18(1):38. doi: 10.1186/s10194-017-0744-z. Epub 2017 Mar 21.
- Background: PubMed 27389092May A, Schulte LH. Chronic migraine: risk factors, mechanisms and treatment. Nat Rev Neurol. 2016 Aug;12(8):455-64. doi: 10.1038/nrneurol.2016.93. Epub 2016 Jul 8.
- Background: PubMed 24662044Schwedt TJ. Chronic migraine. BMJ. 2014 Mar 24;348:g1416. doi: 10.1136/bmj.g1416.
- Background: PubMed 23771276Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013 Jul;33(9):629-808. doi: 10.1177/0333102413485658. No abstract available.
- Background: PubMed 29405250Do TP, Hvedstrup J, Schytz HW. Botulinum toxin: A review of the mode of action in migraine. Acta Neurol Scand. 2018 May;137(5):442-451. doi: 10.1111/ane.12906. Epub 2018 Feb 6.
- Background: PubMed 18806905Carruthers A, Carruthers J. Botulinum toxin products overview. Skin Therapy Lett. 2008 Jul-Aug;13(6):1-4.
- Background: PubMed 21209727Frevert J, Dressler D. Complexing proteins in botulinum toxin type A drugs: a help or a hindrance? Biologics. 2010 Dec 9;4:325-32. doi: 10.2147/BTT.S14902.
- Background: PubMed 20647170Aurora SK, Dodick DW, Turkel CC, DeGryse RE, Silberstein SD, Lipton RB, Diener HC, Brin MF; PREEMPT 1 Chronic Migraine Study Group. OnabotulinumtoxinA for treatment of chronic migraine: results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 1 trial. Cephalalgia. 2010 Jul;30(7):793-803. doi: 10.1177/0333102410364676. Epub 2010 Mar 17.
- Background: PubMed 20647171Diener HC, Dodick DW, Aurora SK, Turkel CC, DeGryse RE, Lipton RB, Silberstein SD, Brin MF; PREEMPT 2 Chronic Migraine Study Group. OnabotulinumtoxinA for treatment of chronic migraine: results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 2 trial. Cephalalgia. 2010 Jul;30(7):804-14. doi: 10.1177/0333102410364677. Epub 2010 Mar 17.
- Background: PubMed 22797868Rendas-Baum R, Bloudek LM, Maglinte GA, Varon SF. The psychometric properties of the Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ) in chronic migraine patients. Qual Life Res. 2013 Jun;22(5):1123-33. doi: 10.1007/s11136-012-0230-7. Epub 2012 Jul 15.
- Background: PubMed 29857565Ion I, Renard D, Le Floch A, De Verdal M, Bouly S, Wacongne A, Lozza A, Castelnovo G. Monocentric Prospective Study into the Sustained Effect of Incobotulinumtoxin A (XEOMIN(R)) Botulinum Toxin in Chronic Refractory Migraine. Toxins (Basel). 2018 Jun 1;10(6):221. doi: 10.3390/toxins10060221.
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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.
Jacqueline S Buckley, PharmD principal investigator
Naval Medical Center Camp Lejeune
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IncobotulinumtoxinA (XEOMIN®) and OnabotulinumtoxinA (BOTOX®) in people with Chronic Migraine, run by Naval Medical Center Camp Lejeune 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 7 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 22 Jul 2026. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jacqueline S Buckley, PharmD ((910) 443-2783, jacqueline.s.buckley.civ@health.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache days per month (time frame: 24 weeks + Baseline). 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 NCT05598723, which also lists 22 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 22 Jul 2026.