NCT04580238|WithdrawnPhase 1DMC
Study Stopped
Logistical issues
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Sponsor study identifier
interventional
0
1 country
1
Study Start
December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
January 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Post stroke headache occurs in approximately 10-23% of all stroke patients. Its onset is shortly after experiencing a stroke, or stroke like event, and persists for at least three months. These headaches have features which resemble migraine or occur in people who have a previous history of migraine that was once infrequent. Botox is a treatment that is currently approved for the treatment of chronic migraine, that is migraine headaches occurring for at least 15 days a month for at least 3 months. Given the clinical similarity in character and frequency of post stroke headache and migraine, and the fact that stroke affects structures like the blood vessels in the brain that are also affected in migraine, this study is to investigate the possible role that Botox would have in the treatment of Post-Stroke Headache.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2, 2020
Actual (reported)October 8, 2020
Actual (reported)December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Change in Number of Migraine Days
Change in number of migraine days per month
after completion of treatment cycles (2 years)
Change in Number of Moderate to Severe Migraine Days.
Change in Number of Moderate to Severe Migraine Days per month
after completion of treatment cycles (2 years)
Responder Rates
proportion of patients who experience: a ≥50% reduction in headache days, a ≥50% reduction in moderate/severe headache days, a ≥50% reduction in total cumulative hours of headache on headache days and a ≥5- point improvement in HIT-6 scores.
after completion of treatment cycles (2 years)
The treatment group will consist of 40 patients randomly allocated to receiving Botox according to the treatment regime.
The control group will consist of 40 patients randomly allocated to Non-Botox, standard of care treatments, to a total study population of 80 patients.
Treatment Protocol: Botox 200 IU vials for 40 patients for the duration of study (4 treatment cycles); Treatment will be based on the PREEMPT study full treatment (standard of care) and follow the pain protocol to a total of 195 IU in standard injection sites
Division of Neurology, Grey Nuns Community Hospital
Edmonton, Alberta, T8B1C9, Canada
Hansen AP, Marcussen NS, Klit H, Kasch H, Jensen TS, Finnerup NB. Development of persistent headache following stroke: a 3-year follow-up. Cephalalgia. 2015 Apr;35(5):399-409. doi: 10.1177/0333102414545894. Epub 2014 Aug 27.
Inanc Y, Orhan FO, Inanc Y. The effects of Maras powder use on patients with migraine. Neuropsychiatr Dis Treat. 2018 May 7;14:1143-1148. doi: 10.2147/NDT.S164818. eCollection 2018.
Muzaffar M Siddiqui, MD
University of Alberta
0 participants (actual enrollment reported by the registry).
First Submitted
October 2, 2020
First Posted
October 8, 2020
Headache Intensity
after completion of treatment cycles (2 years)
Cumulative hours per 28 days of moderate/severe pain:
after treatment of completion cycles (2 years)
Conversion to episodic migraine.
after treatment of completion cycles (2 years)
Scale for depression
after treatment of completion cycles (2 years)
Headache Impact Test-6 (HIT-6)
after treatment of completion cycles (2 years)
Post Stroke Fatigue (Fatigue Severity Scale)
after treatment of completion cycles (2 years)
Control Group will receive normal standard of care Non-Botox based interventions.
Contact the study team to confirm eligibility.
Lai J, Harrison RA, Plecash A, Field TS. A Narrative Review of Persistent Post-Stroke Headache - A New Entry in the International Classification of Headache Disorders, 3rd Edition. Headache. 2018 Oct;58(9):1442-1453. doi: 10.1111/head.13382. Epub 2018 Aug 27.
Gallerini S, Marsili L, Bartalucci M, Marotti C, Chiti A, Marconi R. Headache secondary to cervical artery dissections: practice pointers. Neurol Sci. 2019 Mar;40(3):613-615. doi: 10.1007/s10072-018-3576-y. Epub 2018 Sep 19.
Aurora SK, Brin MF. Chronic Migraine: An Update on Physiology, Imaging, and the Mechanism of Action of Two Available Pharmacologic Therapies. Headache. 2017 Jan;57(1):109-125. doi: 10.1111/head.12999. Epub 2016 Dec 2.
Silberstein SD, Dodick DW, Aurora SK, Diener HC, DeGryse RE, Lipton RB, Turkel CC. Per cent of patients with chronic migraine who responded per onabotulinumtoxinA treatment cycle: PREEMPT. J Neurol Neurosurg Psychiatry. 2015 Sep;86(9):996-1001. doi: 10.1136/jnnp-2013-307149. Epub 2014 Dec 12.
Maasumi K, Thompson NR, Kriegler JS, Tepper SJ. Effect of OnabotulinumtoxinA Injection on Depression in Chronic Migraine. Headache. 2015 Oct;55(9):1218-24. doi: 10.1111/head.12657. Epub 2015 Sep 18.
Klinedinst NJ, Schuh R, Kittner SJ, Regenold WT, Kehs G, Hoch C, Hackney A, Fiskum G. Post-stroke fatigue as an indicator of underlying bioenergetics alterations. J Bioenerg Biomembr. 2019 Apr;51(2):165-174. doi: 10.1007/s10863-018-9782-8. Epub 2019 Jan 7.
Study Start
December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
January 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 19, 2024
Record last verified: 2024-09
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