Trigeminal Neuralgia
Conditions
Keywords
botox, injection, trigeminal neuralgia
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.
Interventions
Intradermal injections will be placed in 25 unit aliquots allocated per affected trigeminal distribution. For example, if the target is the V1 territory, then the patient would get 25 units injected into the V1 distribution. This would be divided into 2.5 units per injection in 10 injection sites as outlined on the map. If V1/V2 were affected, the patient would get 50 units of onabotA. Maximum dose of 75 units if all three trigeminal distributions are involved. We have developed a specific map for administering the doses and this will be followed.
DRUGSodium Chloride 0.9% for Injection, Preservative Free
intradermal injections will be placed in 25 unit aliquots allocated per affected trigeminal distribution. For example, if the target is the V1 territory, then the patient would get 25 units injected into the V1 distribution. This would be divided into 2.5 units per injection in 10 injection sites as outlined on the map. If V1/V2 were affected, the patient would get 50 units of saline. Maximum dose of 75 units if all three trigeminal distributions are involved. We have developed a specific map for administering the doses and this will be followed.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, 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.
Intervention model description
This will be a randomized controlled trial of onabotulinumtoxinA versus Saline intradermal injections into the affected trigeminal distributions. The RCT will be enriched with all participants being initial responders to a preliminary round of onatbotulinumtoxinA.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 Patient Global Impression of Change | week 4 | A single self administered question given at week 4 |
Countries
United States
Contacts
CONTACTMeredith Barad, MD
CONTACTNatali Ariyoshi
PRINCIPAL_INVESTIGATORMeredith Barad, MD
Stanford University
Outcome results
None listed