Onabotulinum Toxin A (Botox) for the Treatment of Persistent Post-Stroke and Vascular Headache (NCT04580238) | Clinical Trial Compass
WithdrawnPhase 1
Onabotulinum Toxin A (Botox) for the Treatment of Persistent Post-Stroke and Vascular Headache
Stopped: Logistical issues
Canada0Started 2023-12
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Adult patients (\>18 y) fulfilling ICHD-3 criteria\* of persistent post stroke/hemorrhagic stroke headache; persistent headache post dissection\* and post RCVS persistent headache will be enrolled at 3 months or greater of persistence of symptoms.
✓. The syndrome of post CVST headache patients will only be enrolled after symptoms have persisted for a minimum of 6 months and after relevant imaging demonstrates a resolution of potentially structural contribution from the sentinel event (i.e. recanalization or chronic thrombo- sis with a normal opening pressure on lumbar puncture).
Exclusion criteria
✕. Tension type Post Stroke Persisting Headache, Post stroke pain syndrome such as the Thalamic syndrome of Dejerine-Roussy, or any headache semiology that does not fulfill diagnostic criteria for chronic migraine, will be excluded.
✕. Contraindications to Botox, neuromuscular illness or documented hyper- sensitivity will preclude randomization of patients.
✕. Concurrent active systemic illness, such as sepsis, chronic infective processes, neoplastic syndromes, or autoimmune syndromes. (Headache secondary to medical illness, even if occurring post-stroke).
✕. Subjects must be screened for coexistent (including psychiatric) conditions to exclude illnesses that may influence the conduct or results of the trial. Subjects with coexisting conditions, such as depression, may be included if they are defined a priori, stable on current treatment regimens (with no anticipated changes in management that may interfere with study results), and recorded throughout the study. One of the secondary outcome measures in the study investigates the potential impact on concurrent symptoms of depression. However, the stability of symptoms treatment and concomitant medications should be assessed prior to inclusion in the study. If factors are identified which might interfere with patient compliance, follow up or confound results, such patients should be excluded. Other common reasons for exclusion include severe depression and overuse of alcohol or illicit drugs, as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition.
What they're measuring
1
Change in Number of Migraine Days
Timeframe: after completion of treatment cycles (2 years)
2
Change in Number of Moderate to Severe Migraine Days.
Timeframe: after completion of treatment cycles (2 years)
3
Responder Rates
Timeframe: after completion of treatment cycles (2 years)