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

NCT04580238 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2024-09-19

No results posted yet for this study

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.

Conditions

  • Stroke (CVA) or TIA
  • Headache, Migraine
  • Botulinum Toxins, Type A
  • Cerebral Venous Sinus Thrombosis
  • Carotid Dissection Artery
  • Vertebral Dissection Artery
  • Hemorrhagic Stroke
  • Reversible Cerebral Vasoconstriction Syndrome

Interventions

DRUG

Botox 200 UNT Injection

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

COMBINATION_PRODUCT

Non Botox based Standard of Care Treatments for Headache/Migraine

Control Group will receive normal standard of care Non-Botox based interventions.

Sponsors & Collaborators

  • University of Alberta

    lead OTHER

Principal Investigators

  • Muzaffar M Siddiqui, MD · University of Alberta

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-31
Primary Completion
2025-01-31
Completion
2025-06-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04580238 on ClinicalTrials.gov