OnabotulinumtoxinA for Trigeminal Neuralgia
- Conditions
- Trigeminal Neuralgia
- Interventions
- Drug: Sodium Chloride 0.9% for Injection, Preservative Free
- Registration Number
- NCT06216886
- Lead Sponsor
- Stanford University
- Brief Summary
A randomized controlled trial comparing Onabotulinumtoxin A to saline (placebo) for Trigeminal Neuralgia.
- Detailed Description
This study will offer onabotulinumtoxin A (Botox) delivered intradermally into the region of pain for the patient with trigeminal neuralgia. Should they derive benefit from the procedure (as determined by decrease in the frequency of attacks), then they will be randomized to receive either onabotulinumtoxin A or saline and followed for 3 months. This study hopes to provide strong data that this is a treatment option for patients with TN who have failed medications, but are not ready for or do not want to undergo surgery.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
Men and women age 18 or older
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description OnabotulinumtoxinA OnabotulinumtoxinA 100 UNT [Botox] Intradermal injections will be placed in the affected trigeminal territories according to a specific facial map that we have developed. Saline Sodium Chloride 0.9% for Injection, Preservative Free The same procedure will be followed as above, but saline will be injected instead of onabotA
- Primary Outcome Measures
Name Time Method Change in Number of TN Attacks per week compare data from week -1(7 days prior to starting study) and week 4(7 days during the 4th week after treatment)) Frequency of TN attacks before and after onabotA injection over a seven day period
- Secondary Outcome Measures
Name Time Method Change in PROMIS Computer Adaptive Tests (PROMIS PROFILE CAT V1.0 -29) compare data from week -1(7 days prior to starting study) and week 4(7 days during the 4th week after treatment) Computer adaptive tests (CATs) assess anxiety, depression, fatigue, pain interference, physical function, sleep disturbance and ability to participate in social roles and activities, and pain intensity.
Change In Acute Medication Use compare data from week -1(7 days prior to starting study) and week 4(7 days during the 4th week after treatment) Number of doses of any acute medication use over a 7 day period
Change in Severity of Attacks Based using the numerical rating scale (NRS) compare data from week -1(7 days prior to starting study) and week 4(7 days during the 4th week after treatment) Average severity of attack over a 7 day period
Change In Baseline Pain Average using the numerical rating scale (NRS) compare data from week -1(7 days prior to starting study) and week 4(7 days during the 4th week after treatment) baseline pain average over a seven day period
Change In Patient Global Impression of Change week 4 A single self administered question given at week 4
Trial Locations
- Locations (1)
Meredith Barad
🇺🇸Stanford, California, United States