Botox for Trigeminal Neuralgia

Phase 4

Recruiting

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

Must not have

Secondary or Idiopathic TN, or Painful Trigeminal Neuropathy as defined by the ICHD (13.1.1.2, 13.1.1.3, 13.1.2)

Neuromuscular disease

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

Drug Has Already Been Approved

Pivotal Trial

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with a specific type of facial pain.

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I have a neuromuscular disease.

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I am currently taking aminoglycoside antibiotics.

Timeline

Screening ~ 3 weeks3 visits

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)

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.