Onabotulinum Toxin A (Botox) for the Treatment of Persistent Post-Stroke and Vascular Headache

Not yet recruiting
Trial end date:
Target enrollment:
Participant gender:
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.
Phase 1
Accepts Healthy Volunteers?
Lead Sponsor:
University of Alberta
Inclusion Criteria:

1. 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

For the purposes of this study, as suggested elsewhere in the literature, the initial
onset of headache will be considered for study if occurring within 72 hours prior to
and 7 days post sentinel vascular event ("Stroke"). The 72 hours prior criteria
allowing for inclusion of patients of intracerebral hemorrhage who are known to have
anticipatory headache as well as alternate ischemic syndromes in which new onset
headache may anticipate stroke symptoms such as dissection and reversible
cerebro-vasoconstriction syndrome.

2. 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

- Note the patients of post dissection persistent headaches may be enrolled despite
the absence of an identified ischemic lesion, i.e. in the setting of TIA or new
onset headache without embolic symptoms but with a history of the (stabilized)
vascular injury associated with the syndrome.

- Note the co-existence of medication overuse headache will not be a
contraindication to randomization.

Exclusion Criteria:

1. 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.

2. Contraindications to Botox, neuromuscular illness or documented hyper- sensitivity
will preclude randomization of patients.

3. 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).

4. 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.

5. CGRP inhibitors will be contraindicated during the period of study.