NCT04580238

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

Withdrawn Phase 1 Last updated 11 September 2024

What this trial tests

Phase 1 trial testing Botox 200 UNT Injection in Stroke (CVA) or TIA. Withdrawn.

Timeline

1 December 2023

Primary endpoint
1 January 2025

1 June 2025

Quick facts

Lead sponsor	University of Alberta
Phase	Phase 1
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Start date	1 December 2023
Primary completion	1 January 2025
Estimated completion	1 June 2025
Sites	1 location across Canada

Drugs / interventions tested

• Botox 200 UNT Injection — full drug profile →
• Non Botox based Standard of Care Treatments for Headache/Migraine

Conditions studied

• Stroke (CVA) or TIA — all drugs for Stroke (CVA) or TIA →
• Headache, Migraine — all drugs for Headache, Migraine →
• Botulinum Toxins, Type A — all drugs for Botulinum Toxins, Type A →
• Cerebral Venous Sinus Thrombosis — all drugs for Cerebral Venous Sinus Thrombosis →

Sponsor

University of Alberta

Who can join

18 and older, any sex, with Stroke (CVA) or TIA or Headache, Migraine. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change in Number of Migraine Days
  Time frame: after completion of treatment cycles (2 years)
  Change in number of migraine days per month
• Change in Number of Moderate to Severe Migraine Days.
  Time frame: after completion of treatment cycles (2 years)
  Change in Number of Moderate to Severe Migraine Days per month
• Responder Rates
  Time frame: after completion of treatment cycles (2 years)
  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.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. OnabotulinumtoxinA in Migraine: A Review of the Literature and Factors Associated with Efficacy.
   Ray JC, Hutton EJ, Matharu M. · · 2021 · cited 15× · PMID 34209849 · DOI 10.3390/jcm10132898