Randomized Controlled Trial of Intradermal Injections of OnabotulinumtoxinA vs Saline for Trigeminal Neuralgia.
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Stanford University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Change in Number of TN Attacks per week
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Masking Description
After the initial round of botox, all participants will be randomized to either onabotA or saline. The randomization will performed by a provider who is not a care provider or proceduralist.
The patient will be blinded, the proceduralist will be blinded and the care provider will be blinded. Data will be stored and not reviewed by research team until the study closes.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
OnabotulinumtoxinA
Intradermal injections will be placed in the affected trigeminal territories according to a specific facial map that we have developed.
Intervention: OnabotulinumtoxinA 100 UNT [Botox] (Drug)
Saline
The same procedure will be followed as above, but saline will be injected instead of onabotA
Intervention: Sodium Chloride 0.9% for Injection, Preservative Free (Drug)
Outcomes
Primary Outcomes
Change in Number of TN Attacks per week
Time Frame: 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 Outcomes
- 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))
- 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))
- 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))
- 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))
- Change In Patient Global Impression of Change(week 4)
Investigators
Meredith Barad
Clinical Associate Professor of Anesthesiology (Pain) and Neurology & Neurological Sciences
Stanford University