Trial Outcomes & Findings for BOTOX Effects on Seizure Severity and Susceptibility (NCT NCT05605756)
NCT ID: NCT05605756
Last Updated: 2026-06-29
Results Overview
TMS metrics of rMT, CSP, LICI, and TMS-EEG excitability metrics will each be averaged over at least 20 trials per subject per time block (at baseline, and 3 weeks and 8 weeks after BOTOX injections). Per metric mean values will then be compared by one-way repeated measures ANOVA.
TERMINATED
PHASE4
3 participants
150 days
2026-06-29
Participant Flow
none of the patients that consented reached the baseline timepoint for the trial
Participant milestones
| Measure |
Botox Therapy Effects on Seizure
OnabotulinumtoxinA 145 UNT \[Botox\]: Botulinum A toxin injection: Will follow the FDA-approved guideline of the treatment of chronic migraine. The following modifications are planned: (a) Total units 145 instead of 155. (b) Number of injection sites 29 instead of 31. (c) the 6 injection sites in the trapezius muscle will be eliminated as they are irrelevant to our attempt to reduce seizure events. Instead, 4 injections will be made subcutaneously along the superior sagittal suture (see figures below), where no muscles exist and thus no muscle weakness is likely. This dose (145 Units) is well below the FDA-approved guideline on safety for adolescents and adults (no more than 10 Units/Kg or a total of 340 Units).
Botox injections will take place in the BIDMC Headache Clinic which is a part of the Arnold Pain center at 1 Brookline Place. Injections will be administered by Dr. Sait Ashina, the Director of the Headache Clinic.
|
|---|---|
|
Overall Study
STARTED
|
0
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
none of the patients that consented reached the baseline timepoint for the trial
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: 150 daysPopulation: none of the patients that consented reached the baseline timepoint for the trial
TMS metrics of rMT, CSP, LICI, and TMS-EEG excitability metrics will each be averaged over at least 20 trials per subject per time block (at baseline, and 3 weeks and 8 weeks after BOTOX injections). Per metric mean values will then be compared by one-way repeated measures ANOVA.
Outcome measures
| Measure |
Botox Therapy Effects on Seizure
OnabotulinumtoxinA 145 UNT \[Botox\]: Botulinum A toxin injection: Will follow the FDA-approved guideline of the treatment of chronic migraine. The following modifications are planned: (a) Total units 145 instead of 155. (b) Number of injection sites 29 instead of 31. (c) the 6 injection sites in the trapezius muscle will be eliminated as they are irrelevant to our attempt to reduce seizure events. Instead, 4 injections will be made subcutaneously along the superior sagittal suture (see figures below), where no muscles exist and thus no muscle weakness is likely. This dose (145 Units) is well below the FDA-approved guideline on safety for adolescents and adults (no more than 10 Units/Kg or a total of 340 Units).
Botox injections will take place in the BIDMC Headache Clinic which is a part of the Arnold Pain center at 1 Brookline Place. Injections will be administered by Dr. Sait Ashina, the Director of the Headache Clinic.
|
|---|---|
|
Change in Net Cortical Excitability Metrics
|
0 Participants
|
SECONDARY outcome
Timeframe: 150 daysPopulation: none of the patients that consented reached the baseline timepoint for the trial
Blended Neuro-QOL scores will be averaged at baseline, and at the 8-12 week after BOTOX injection period, and compared by paired t-test
Outcome measures
| Measure |
Botox Therapy Effects on Seizure
OnabotulinumtoxinA 145 UNT \[Botox\]: Botulinum A toxin injection: Will follow the FDA-approved guideline of the treatment of chronic migraine. The following modifications are planned: (a) Total units 145 instead of 155. (b) Number of injection sites 29 instead of 31. (c) the 6 injection sites in the trapezius muscle will be eliminated as they are irrelevant to our attempt to reduce seizure events. Instead, 4 injections will be made subcutaneously along the superior sagittal suture (see figures below), where no muscles exist and thus no muscle weakness is likely. This dose (145 Units) is well below the FDA-approved guideline on safety for adolescents and adults (no more than 10 Units/Kg or a total of 340 Units).
Botox injections will take place in the BIDMC Headache Clinic which is a part of the Arnold Pain center at 1 Brookline Place. Injections will be administered by Dr. Sait Ashina, the Director of the Headache Clinic.
|
|---|---|
|
Change in Quality-of-life Metrics
|
0 Participants
|
Adverse Events
Botox Therapy Effects on Seizure
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place