A randomized controlled trial comparing Onabotulinumtoxin A to saline (placebo) for Trigeminal Neuralgia.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
20
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.
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.
Meredith Barad
Stanford, California, United States
RECRUITINGChange in Number of TN Attacks per week
Frequency of TN attacks before and after onabotA injection over a seven day period
Time frame: compare data from week -1(7 days prior to starting study) and week 4(7 days during the 4th week after treatment))
Change in PROMIS Computer Adaptive Tests (PROMIS PROFILE CAT V1.0 -29)
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.
Time frame: 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)
Average severity of attack over a 7 day period
Time frame: 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)
baseline pain average over a seven day period
Time frame: 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
Number of doses of any acute medication use over a 7 day period
Time frame: 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
A single self administered question given at week 4
Time frame: week 4
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