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Neuromuscular Blocker

OnabotulinumtoxinA for Trigeminal Neuralgia

Phase 4
Waitlist Available
Led By Meredith Barad, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Inadequate response to medication - at least 2 trials
Have failed/not a candidate/do not want surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up compare data from week -1(7 days prior to starting study) and week 4(7 days during the 4th week after treatment)
Awards & highlights

Study Summary

This trial is comparing the effectiveness of Onabotulinumtoxin A to a saline placebo for treating Trigeminal Neuralgia.

Who is the study for?
This trial is for individuals with Trigeminal Neuralgia, a condition causing facial pain. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and not have conditions that could interfere with the study.Check my eligibility
What is being tested?
The trial is testing OnabotulinumtoxinA (Botox) against a saline solution (placebo). Participants will be randomly assigned to receive either Botox or placebo in a controlled setting to compare effectiveness.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones associated with Botox may include injection site pain or swelling, headache, flu-like symptoms, and in rare cases more serious effects like muscle weakness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have tried at least 2 medications without success.
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I cannot or do not wish to undergo surgery for my condition.
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I experience more than 10 attacks per week.
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I have been diagnosed with Classical Trigeminal Neuralgia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~compare data from week -1(7 days prior to starting study) and week 4(7 days during the 4th week after treatment)
This trial's timeline: 3 weeks for screening, Varies for treatment, and compare data from week -1(7 days prior to starting study) and week 4(7 days during the 4th week after treatment) 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 TN Attacks per week
Secondary outcome measures
Change In Acute Medication Use
Change In Baseline Pain Average using the numerical rating scale (NRS)
Change In Patient Global Impression of Change
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: OnabotulinumtoxinAExperimental Treatment1 Intervention
Intradermal injections will be placed in the affected trigeminal territories according to a specific facial map that we have developed.
Group II: SalinePlacebo Group1 Intervention
The same procedure will be followed as above, but saline will be injected instead of onabotA

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,394 Previous Clinical Trials
17,341,590 Total Patients Enrolled
3 Trials studying Trigeminal Neuralgia
99 Patients Enrolled for Trigeminal Neuralgia
Meredith Barad, MDPrincipal InvestigatorStanford University

Frequently Asked Questions

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

Are patients currently able to participate in this ongoing research study?

"According to the information available on clinicaltrials.gov, this particular trial is not currently seeking participants. The trial was originally posted on February 1st, 2024 and was last updated on January 11th, 2024. It is important to note that there are currently 129 other ongoing studies actively recruiting patients at this time."

Answered by AI

What level of risk does OnabotulinumtoxinA pose to individuals?

"The safety rating for OnabotulinumtoxinA is determined to be 3, as it is part of a Phase 4 trial and has already received approval for use."

Answered by AI

Who else is applying?

What site did they apply to?
Meredith Barad
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
OnabotulinumtoxinA for Trigeminal Neuralgia
Meredith Barad 2024. "OnabotulinumtoxinA for Trigeminal Neuralgia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06216886.
All > Nerve Pain > Trigeminal Neuralgia
~13 spots leftby Feb 2025
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