Trial Outcomes & Findings for Effects of Clobazam on Sleep and Daytime Function in Patients With Epilepsy (NCT NCT02911025)

Results Overview

The change in total sleep time in patients with epilepsy treat with clobazam one week after reaching effective clobazam dose

Recruitment status

COMPLETED

Target enrollment

13 participants

Primary outcome timeframe

1 week after reaching effective clobazam dose

Results posted on

2021-02-08

Participant milestones
Measure	Patients Treated With Clobazam Single group, patients treated with clobazam by their treating physician (no interventions from PI), followed longitudinally for 1 week after reaching effective clobazam dose.
Overall Study STARTED	13
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	3

Reasons for withdrawal
Measure	Patients Treated With Clobazam Single group, patients treated with clobazam by their treating physician (no interventions from PI), followed longitudinally for 1 week after reaching effective clobazam dose.
Overall Study Lost to Follow-up	3

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort
Measure	Patients Treated With Clobazam n=13 Participants Single group, patients treated with clobazam by their treating physician (no interventions from PI), followed longitudinally for 1 week after reaching effective clobazam dose.
Age, Categorical <=18 years	0 Participants n=13 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=13 Participants
Age, Categorical >=65 years	0 Participants n=13 Participants
Age, Continuous	41 years STANDARD_DEVIATION 11.2 • n=13 Participants
Sex: Female, Male Female	7 Participants n=13 Participants
Sex: Female, Male Male	6 Participants n=13 Participants
Region of Enrollment United States	13 participants n=13 Participants

Timeframe: 1 week after reaching effective clobazam dose

The change in total sleep time in patients with epilepsy treat with clobazam one week after reaching effective clobazam dose

Outcome measures
Measure	Patients Treated With Clobazam n=13 Participants Single group, patients treated with clobazam by their treating physician (no interventions from PI), followed longitudinally for 1 week after reaching effective clobazam dose.
Change in Sleep (Total Sleep Time) in Patients With Epilepsy Treated With Clobazam Baseline Phase	493.2 minutes Standard Deviation 457.9
Change in Sleep (Total Sleep Time) in Patients With Epilepsy Treated With Clobazam Treatment Phase	457.9 minutes Standard Deviation 23.9

Timeframe: 1 week after reaching effective clobazam dose

The change in wake after sleep onset (WASO) in patients with epilepsy treat with clobazam one week after reaching effective clobazam dose

Outcome measures
Measure	Patients Treated With Clobazam n=13 Participants Single group, patients treated with clobazam by their treating physician (no interventions from PI), followed longitudinally for 1 week after reaching effective clobazam dose.
Change in Sleep (Wake After Sleep Onset) in Patients With Epilepsy Treated With Clobazam Baseline Phase	50.2 count of awakenings Standard Deviation 6.9
Change in Sleep (Wake After Sleep Onset) in Patients With Epilepsy Treated With Clobazam Treatment Phase	37.3 count of awakenings Standard Deviation 3.5

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Patients Treated With Clobazam n=13 participants at risk Single group, patients treated with clobazam by their treating physician (no interventions from PI), followed longitudinally for 1 week after reaching effective clobazam dose.
Product Issues Sedation Side Effect	7.7% 1/13 • Number of events 1 • Each patient was followed for one week during the treatment phase.

Brigham and Women's Hospital

Phone: 6174772129