RECRUITING

OnabotulinumtoxinA for Trigeminal Neuralgia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A randomized controlled trial comparing Onabotulinumtoxin A to saline (placebo) for Trigeminal Neuralgia.

Official Title

Randomized Controlled Trial of Intradermal Injections of OnabotulinumtoxinA vs Saline for Trigeminal Neuralgia.

Quick Facts

Study Start:2024-06-01

Study Completion:2025-09-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06216886

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Judged to be of legal competence * Sufficient knowledge of written and spoken English * Capable of attending regular in-person visits * Have failed/not a candidate/do not want surgery * Inadequate response to medication - at least 2 trials * Meeting ICHD criteria for Classical Trigeminal Neuralgia 13.1.1.1 * Patients with frequency \> 10 attacks per week * Stable dose of medications in the last 2 weeks	* Secondary or Idiopathic TN, or Painful Trigeminal Neuropathy as defined by the ICHD (13.1.1.2, 13.1.1.3, 13.1.2) * Pregnant or breast feeding (while it is rare that a patient will be pregnant with TN, there is not sufficient data to say definitively that onabotA is ok to use during pregnancy and nursing, it is still rated Class C) * Neuromuscular disease * On aminoglyocosides * Not currently enrolled in any other studies

Inclusion Criteria

Exclusion Criteria

* Judged to be of legal competence
* Sufficient knowledge of written and spoken English
* Capable of attending regular in-person visits
* Have failed/not a candidate/do not want surgery
* Inadequate response to medication - at least 2 trials
* Meeting ICHD criteria for Classical Trigeminal Neuralgia 13.1.1.1
* Patients with frequency \> 10 attacks per week
* Stable dose of medications in the last 2 weeks

* Secondary or Idiopathic TN, or Painful Trigeminal Neuropathy as defined by the ICHD (13.1.1.2, 13.1.1.3, 13.1.2)
* Pregnant or breast feeding (while it is rare that a patient will be pregnant with TN, there is not sufficient data to say definitively that onabotA is ok to use during pregnancy and nursing, it is still rated Class C)
* Neuromuscular disease
* On aminoglyocosides
* Not currently enrolled in any other studies

Contacts and Locations

Principal Investigator

Meredith Barad, MD

PRINCIPAL_INVESTIGATOR

Stanford University

Study Locations (Sites)

Meredith Barad

Stanford, California, 94304

United States

Collaborators and Investigators

Sponsor: Stanford University

Meredith Barad, MD, PRINCIPAL_INVESTIGATOR, Stanford University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-01

Study Completion Date2025-09-01

Study Record Updates

Study Start Date2024-06-01

Study Completion Date2025-09-01

Terms related to this study

Keywords Provided by Researchers

botox
injection
trigeminal neuralgia

Additional Relevant MeSH Terms

Trigeminal Neuralgia