Trial Outcomes & Findings for Incobotulinum Toxin for the Treatment of Trigeminal Neuralgia (NCT NCT02088632)
NCT ID: NCT02088632
Last Updated: 2023-06-28
Results Overview
Mean daily number of attacks during baseline period (30 days) will be compared to mean daily number of attacks for baseline and 84 days as recorded in patient diary.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
84 days
Results posted on
2023-06-28
Participant Flow
The original target enrollment was 70 subjects
Actual enrollment was 6. Recruitment efforts were limited to patients in our practice who could come in for visits and few responded to recruitment efforts. The appointment openings/schedule for visits was very limited.
Participant milestones
| Measure |
Incobotulinumtoxina
Xeomin 25-100 units injected to chosen area one time.
Incobotulinumtoxina: Incobotulinumtoxina (Xeomin) is botulinum toxin type A and is administered via intramuscular injection.
|
Placebo Comparator
Placebo Comparator is 1-2 ml normal saline solution injected to chosen area one time.
Placebo Comparator: Normal saline is sterile sodium chloride without and preservatives.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Incobotulinum Toxin for the Treatment of Trigeminal Neuralgia
Baseline characteristics by cohort
| Measure |
IncobotulinumtoxinA
n=3 Participants
Xeomin 25-100 units injected to chosen area one time.
|
Placebo Comparator
n=3 Participants
Placebo Comparator is 1-2 ml normal saline solution injected to chosen area one time.
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.3 years
n=99 Participants
|
49.6 years
n=107 Participants
|
52.0 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 84 daysPopulation: Patients treated with Xeomin and patients treated with placebo
Mean daily number of attacks during baseline period (30 days) will be compared to mean daily number of attacks for baseline and 84 days as recorded in patient diary.
Outcome measures
| Measure |
Active
n=3 Participants
Received Xeomin injections
|
Placebo Group
n=3 Participants
Placebo group Did not receive xeomin
|
|---|---|---|
|
Change in Mean Number of Headache Attacks Reported in Active and Placebo Group
|
1.96 attacks per day
Standard Deviation 2.9
|
-200.133 attacks per day
Standard Deviation 286.9
|
SECONDARY outcome
Timeframe: 84 daysPopulation: Descriptive statistics only
Mean of the daily pain intensity as measured on a 0-10 pain scale where 0 = no pain and 10 is the worst pain reported on paper diary from baseline and 84 days
Outcome measures
| Measure |
Active
n=3 Participants
Received Xeomin injections
|
Placebo Group
n=3 Participants
Placebo group Did not receive xeomin
|
|---|---|---|
|
Change in Mean Pain Intensity of Active and Placebo Group
|
-2.66 units on a scale
Standard Deviation .98
|
.73 units on a scale
Standard Deviation .54
|
Adverse Events
Incobotulinumtoxina
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo Comparator
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Incobotulinumtoxina
n=3 participants at risk
Xeomin 25-100 units injected to chosen area one time.
Incobotulinumtoxina: Incobotulinumtoxina (Xeomin) is botulinum toxin type A and is administered via intramuscular injection.
|
Placebo Comparator
n=3 participants at risk
Placebo Comparator is 1-2 ml normal saline solution injected to chosen area one time.
Placebo Comparator: Normal saline is sterile sodium chloride without and preservatives.
|
|---|---|---|
|
General disorders
Drowsiness
|
33.3%
1/3 • Number of events 1 • Adverse events collection was from start of consent to end of study - approximately 84 days
|
0.00%
0/3 • Adverse events collection was from start of consent to end of study - approximately 84 days
|
|
General disorders
muscle weakness
|
33.3%
1/3 • Number of events 1 • Adverse events collection was from start of consent to end of study - approximately 84 days
|
0.00%
0/3 • Adverse events collection was from start of consent to end of study - approximately 84 days
|
|
Skin and subcutaneous tissue disorders
Aphthous ulcers
|
0.00%
0/3 • Adverse events collection was from start of consent to end of study - approximately 84 days
|
33.3%
1/3 • Number of events 1 • Adverse events collection was from start of consent to end of study - approximately 84 days
|
|
Infections and infestations
Sinusitis
|
33.3%
1/3 • Number of events 1 • Adverse events collection was from start of consent to end of study - approximately 84 days
|
0.00%
0/3 • Adverse events collection was from start of consent to end of study - approximately 84 days
|
|
Nervous system disorders
Numbness left temple
|
0.00%
0/3 • Adverse events collection was from start of consent to end of study - approximately 84 days
|
33.3%
1/3 • Number of events 1 • Adverse events collection was from start of consent to end of study - approximately 84 days
|
|
General disorders
Insomnia
|
0.00%
0/3 • Adverse events collection was from start of consent to end of study - approximately 84 days
|
33.3%
1/3 • Number of events 1 • Adverse events collection was from start of consent to end of study - approximately 84 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place