OnabotulinumtoxinA for Trigeminal Neuralgia
ConditionTrigeminal Neuralgia
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorStanford University
About this trial
A randomized controlled trial comparing Onabotulinumtoxin A to saline (placebo) for Trigeminal Neuralgia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
OnabotulinumtoxinA 100 UNT [Botox]
DrugIntradermal 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.
Sodium Chloride 0.9% for Injection, Preservative Free
Drugintradermal 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.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: OnabotulinumtoxinAExperimental treatment 1 intervention
Group B: SalinePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change 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))Secondary outcomes
1
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)2
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)3
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)4
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov