Trial Outcomes & Findings for Use of Clobazam for Epilepsy and Anxiety (NCT NCT03371836)
NCT ID: NCT03371836
Last Updated: 2021-03-04
Results Overview
Mean of Clinical Global Impression-Improvement from baseline. (1-7 point scale; lower score equals a better outcome; 1 is the maximum improvement, 7 is the minimum improvement)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
20 participants
Primary outcome timeframe
14-18 weeks
Results posted on
2021-03-04
Participant Flow
Participant milestones
| Measure |
Clobazam
open label single treatment arm
Clobazam is used as an adjunct medicine for all participants.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Use of Clobazam for Epilepsy and Anxiety
Baseline characteristics by cohort
| Measure |
Open Label Single Treatment Arm
n=20 Participants
open label
Clobazam: Clobazam is used as an adjunct medicine for all participants.
|
|---|---|
|
Age, Categorical
<=18 years
|
20 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
13.8 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 14-18 weeksMean of Clinical Global Impression-Improvement from baseline. (1-7 point scale; lower score equals a better outcome; 1 is the maximum improvement, 7 is the minimum improvement)
Outcome measures
| Measure |
Clobazam
n=18 Participants
open label single treatment arm
Clobazam is used as an adjunct medicine for all participants.
|
|---|---|
|
CGI-I
|
2 units on a scale
Interval 1.0 to 7.0
|
Adverse Events
Open Label Single Treatment Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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