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Neurotoxin

Botox for Migraine

Phase 1
Waitlist Available
Led By Muzaffar M Siddiqui, MD
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after treatment of completion cycles (2 years)
Awards & highlights

Study Summary

This trial is investigating whether Botox could be an effective treatment for post-stroke headaches, which are similar to migraines.

Who is the study for?
Adults over 18 with persistent headaches that started after a stroke or similar vascular event and have lasted for at least 3 months, or in some cases, 6 months. Patients should meet specific headache criteria and not have tension-type headaches, certain post-stroke pain syndromes, neuromuscular illnesses, hypersensitivity to Botox, or be taking CGRP inhibitors.Check my eligibility
What is being tested?
The trial is testing the effectiveness of Botox injections (200 units) compared to standard non-Botox treatments for chronic migraines in managing persistent headaches following a stroke. The goal is to see if Botox can reduce these post-stroke headache symptoms.See study design
What are the potential side effects?
Possible side effects of Botox may include pain at the injection site, muscle weakness near where the medicine was injected, drooping eyelids, eye dryness or excessive tearing; and less commonly general muscle weakness.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after treatment of completion cycles (2 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and after treatment of completion cycles (2 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Number of Migraine Days
Change in Number of Moderate to Severe Migraine Days.
Responder Rates
Secondary outcome measures
Conversion to episodic migraine.
Cumulative hours per 28 days of moderate/severe pain
Headache Intensity
+1 more
Other outcome measures
Headache Impact Test-6 (HIT-6)
Post Stroke Fatigue (Fatigue Severity Scale)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment ArmExperimental Treatment1 Intervention
The treatment group will consist of 40 patients randomly allocated to receiving Botox according to the treatment regime.
Group II: ControlActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor
886 Previous Clinical Trials
384,778 Total Patients Enrolled
Muzaffar M Siddiqui, MDPrincipal InvestigatorUniversity of Alberta

Media Library

Onabotulinum Toxin A (Botox) (Neurotoxin) Clinical Trial Eligibility Overview. Trial Name: NCT04580238 — Phase 1
Hemorrhagic Stroke Research Study Groups: Control, Treatment Arm
Hemorrhagic Stroke Clinical Trial 2023: Onabotulinum Toxin A (Botox) Highlights & Side Effects. Trial Name: NCT04580238 — Phase 1
Onabotulinum Toxin A (Botox) (Neurotoxin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04580238 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical symptomology is Botox 200 UNT Injection typically used to alleviate?

"Botox 200 UNT Injection can be a viable solution for treating urinary incontinence, but it also has applications in the management of numerous ailments including spinal cord issues, botulism, and overactive bladder syndrome (OABs)."

Answered by AI

Does the FDA sanction Botox 200 UNT Injection?

"With the limited data available on Botox 200 UNT Injection, it has been assigned a safety rating of 1. This Phase 1 trial is still in its early stages and does not have significant evidence for either efficacy or safety."

Answered by AI

Are there any historical accounts of employing Botox 200 UNT Injection for research purposes?

"Currently, there are a total of 61 clinical trials for Botox 200 UNT Injection taking place. Of these, 20 have advanced to Phase 3 testing. Most studies are being conducted in Farmington Hills, Michigan; however, global participation and data collection is occurring at 754 sites worldwide."

Answered by AI

What are the principal aims of this clinical experiment?

"This clinical trial will evaluate the efficacy of a treatment over a two year period, with the primary outcome being change in number of moderate to severe migraine days. Secondary outcomes include headache intensity measured on an 11-point visual rating scale (VRS), cumulative hours per 28 days of moderate/severe pain, and conversion to episodic migraine based upon fewer than 14 migraine or headache days per four weeks for 12 consecutive weeks."

Answered by AI

Are there any opportunities for patients to join this clinical trial?

"This trial is no longer actively recruiting patients. It was posted on December 1st 2022 and last updated on July 11th 2022. Fortunately, there are 1453 clinical trials for hemorrhagic stroke still seeking enrolment as well as 61 studies involving Botox 200 UNT Injection that remain open to participants."

Answered by AI

How many participants have currently been recruited for this experiment?

"This research project has concluded its recruitment process, with the initial post on December 1st 2022 and last edit being made July 11th 2022. If you are still interested in partaking in a trial of this nature, there are currently 1453 clinical trials involving hemorrhagic stroke and 61 studies for Botox 200 UNT Injection recruiting patients."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
65+
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
Division of Neurology, Grey Nuns Community Hospital

Why did patients apply to this trial?

My go to drug is Tylenol, I prefer Advil but can't take it. Paracetamol and Advil, these over the counter pain killers were just making me perspire but I still had a throbbing headache.
PatientReceived no prior treatments
Recent research and studies
~0 spots leftby Jan 2025