Trial Outcomes & Findings for Clobazam in Patients With Lennox-Gastaut Syndrome (NCT NCT00518713)
NCT ID: NCT00518713
Last Updated: 2012-02-09
Results Overview
Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
238 participants
Primary outcome timeframe
4-week baseline period and 12-week maintenance period
Results posted on
2012-02-09
Participant Flow
Participant milestones
| Measure |
Clobazam Low Dose
0.25 mg/kg/day; tablets; orally; for 15-18 weeks
|
Clobazam Medium Dose
0.5 mg/kg/day; tablets; orally; for 15-18 weeks
|
Clobazam High Dose
1.0 mg/kg/day; tablets; orally; for 15-18 weeks
|
Placebo
tablets; orally; daily for 15-18 weeks
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
58
|
62
|
59
|
59
|
|
Overall Study
Modified Intent-to-Treat Population
|
53
|
58
|
49
|
57
|
|
Overall Study
COMPLETED
|
50
|
45
|
41
|
41
|
|
Overall Study
NOT COMPLETED
|
8
|
17
|
18
|
18
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clobazam in Patients With Lennox-Gastaut Syndrome
Baseline characteristics by cohort
| Measure |
Clobazam Low Dose
n=58 Participants
0.25 mg/kg/day; tablets; orally; for 15-18 weeks
|
Clobazam Medium Dose
n=62 Participants
0.5 mg/kg/day; tablets; orally; for 15-18 weeks
|
Clobazam High Dose
n=59 Participants
1.0 mg/kg/day; tablets; orally; for 15-18 weeks
|
Placebo
n=59 Participants
tablets; orally; daily for 15-18 weeks
|
Total
n=238 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
48 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
193 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age Continuous
|
10.9 years
STANDARD_DEVIATION 7.24 • n=5 Participants
|
14.1 years
STANDARD_DEVIATION 10.42 • n=7 Participants
|
11.7 years
STANDARD_DEVIATION 8.48 • n=5 Participants
|
13.0 years
STANDARD_DEVIATION 9.17 • n=4 Participants
|
12.4 years
STANDARD_DEVIATION 8.96 • n=21 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
94 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
144 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 4-week baseline period and 12-week maintenance periodPopulation: Modified Intent-to-Treat (MITT) population
Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.
Outcome measures
| Measure |
Clobazam Low Dose
n=53 Participants
0.25 mg/kg/day; tablets; orally; for 15-18 weeks
|
Clobazam Medium Dose
n=58 Participants
0.5 mg/kg/day; tablets; orally; for 15-18 weeks
|
Clobazam High Dose
n=49 Participants
1.0 mg/kg/day; tablets; orally; for 15-18 weeks
|
Placebo
n=57 Participants
tablets; orally; daily for 15-18 weeks
|
|---|---|---|---|---|
|
Percent Reduction in Number of Drop Seizures (12-week Maintenance Period).
|
41.2 Percent Reduction
Interval -119.0 to 100.0
|
49.4 Percent Reduction
Interval -262.0 to 100.0
|
68.3 Percent Reduction
Interval -39.0 to 100.0
|
12.1 Percent Reduction
Interval -374.0 to 100.0
|
SECONDARY outcome
Timeframe: 4-week baseline period and the first 4 weeks of the 12-week maintenance periodPopulation: MITT population
Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.
Outcome measures
| Measure |
Clobazam Low Dose
n=53 Participants
0.25 mg/kg/day; tablets; orally; for 15-18 weeks
|
Clobazam Medium Dose
n=58 Participants
0.5 mg/kg/day; tablets; orally; for 15-18 weeks
|
Clobazam High Dose
n=49 Participants
1.0 mg/kg/day; tablets; orally; for 15-18 weeks
|
Placebo
n=57 Participants
tablets; orally; daily for 15-18 weeks
|
|---|---|---|---|---|
|
Percent Reduction in Number of Drop Seizures (First 4 Weeks of the 12-week Maintenance Period).
|
47.8 Percent reduction
Interval -103.0 to 100.0
|
58.9 Percent reduction
Interval -147.0 to 100.0
|
71.0 Percent reduction
Interval -58.0 to 100.0
|
18.6 Percent reduction
Interval -106.0 to 100.0
|
SECONDARY outcome
Timeframe: 4-week baseline period and the middle 4 weeks of the 12-week maintenance periodNumber of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.
Outcome measures
| Measure |
Clobazam Low Dose
n=52 Participants
0.25 mg/kg/day; tablets; orally; for 15-18 weeks
|
Clobazam Medium Dose
n=53 Participants
0.5 mg/kg/day; tablets; orally; for 15-18 weeks
|
Clobazam High Dose
n=44 Participants
1.0 mg/kg/day; tablets; orally; for 15-18 weeks
|
Placebo
n=47 Participants
tablets; orally; daily for 15-18 weeks
|
|---|---|---|---|---|
|
Percent Reduction in Number of Drop Seizures (Middle 4 Weeks of the 12-week Maintenance Period).
|
44.1 Percent reduction
Interval -36.0 to 100.0
|
38.8 Percent reduction
Interval -433.0 to 100.0
|
64.9 Percent reduction
Interval -125.0 to 100.0
|
21.1 Percent reduction
Interval -284.0 to 100.0
|
SECONDARY outcome
Timeframe: 4-week baseline period and the last 4 weeks of the 12-week maintenance periodNumber of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.
Outcome measures
| Measure |
Clobazam Low Dose
n=51 Participants
0.25 mg/kg/day; tablets; orally; for 15-18 weeks
|
Clobazam Medium Dose
n=46 Participants
0.5 mg/kg/day; tablets; orally; for 15-18 weeks
|
Clobazam High Dose
n=42 Participants
1.0 mg/kg/day; tablets; orally; for 15-18 weeks
|
Placebo
n=44 Participants
tablets; orally; daily for 15-18 weeks
|
|---|---|---|---|---|
|
Percent Reduction in Number of Drop Seizures (Last 4 Weeks of the 12-week Maintenance Period).
|
31.8 Percent reduction
Interval -477.0 to 100.0
|
56.0 Percent reduction
Interval -228.0 to 100.0
|
68.0 Percent reduction
Interval -117.0 to 100.0
|
-0.1 Percent reduction
Interval -948.0 to 100.0
|
SECONDARY outcome
Timeframe: 4-week baseline period and the 12-week maintenance periodNumber of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.
Outcome measures
| Measure |
Clobazam Low Dose
n=53 Participants
0.25 mg/kg/day; tablets; orally; for 15-18 weeks
|
Clobazam Medium Dose
n=58 Participants
0.5 mg/kg/day; tablets; orally; for 15-18 weeks
|
Clobazam High Dose
n=49 Participants
1.0 mg/kg/day; tablets; orally; for 15-18 weeks
|
Placebo
n=57 Participants
tablets; orally; daily for 15-18 weeks
|
|---|---|---|---|---|
|
Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (12-week Maintenance Period).
≥ 25% reduction
|
34 Percent of responders
Interval 0.83 to 4.2
|
46 Percent of responders
Interval 1.61 to 9.59
|
41 Percent of responders
Interval 2.14 to 14.3
|
28 Percent of responders
|
|
Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (12-week Maintenance Period).
≥ 50% reduction
|
23 Percent of responders
|
34 Percent of responders
|
38 Percent of responders
|
18 Percent of responders
|
|
Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (12-week Maintenance Period).
≥ 75% reduction
|
15 Percent of responders
|
22 Percent of responders
|
31 Percent of responders
|
6 Percent of responders
|
|
Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (12-week Maintenance Period).
100% reduction
|
4 Percent of responders
|
7 Percent of responders
|
12 Percent of responders
|
2 Percent of responders
|
SECONDARY outcome
Timeframe: 4-week baseline period and the first 4 weeks of the 12-week maintenance periodPopulation: MITT
Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.
Outcome measures
| Measure |
Clobazam Low Dose
n=53 Participants
0.25 mg/kg/day; tablets; orally; for 15-18 weeks
|
Clobazam Medium Dose
n=58 Participants
0.5 mg/kg/day; tablets; orally; for 15-18 weeks
|
Clobazam High Dose
n=49 Participants
1.0 mg/kg/day; tablets; orally; for 15-18 weeks
|
Placebo
n=57 Participants
tablets; orally; daily for 15-18 weeks
|
|---|---|---|---|---|
|
Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (First 4 Weeks of the 12-week Maintenance Period).
≥ 25% reduction
|
71.7 Percent of responders
|
82.8 Percent of responders
|
89.8 Percent of responders
|
52.6 Percent of responders
|
|
Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (First 4 Weeks of the 12-week Maintenance Period).
≥ 50% reduction
|
47.2 Percent of responders
|
72.4 Percent of responders
|
77.6 Percent of responders
|
31.6 Percent of responders
|
|
Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (First 4 Weeks of the 12-week Maintenance Period).
≥ 75% reduction
|
35.8 Percent of responders
|
44.8 Percent of responders
|
63.3 Percent of responders
|
14.0 Percent of responders
|
|
Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (First 4 Weeks of the 12-week Maintenance Period).
100% reduction
|
13.2 Percent of responders
|
19.0 Percent of responders
|
30.6 Percent of responders
|
3.5 Percent of responders
|
SECONDARY outcome
Timeframe: 4-week baseline period and the middle 4 weeks of the 12-week maintenance periodNumber of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.
Outcome measures
| Measure |
Clobazam Low Dose
n=53 Participants
0.25 mg/kg/day; tablets; orally; for 15-18 weeks
|
Clobazam Medium Dose
n=58 Participants
0.5 mg/kg/day; tablets; orally; for 15-18 weeks
|
Clobazam High Dose
n=49 Participants
1.0 mg/kg/day; tablets; orally; for 15-18 weeks
|
Placebo
n=57 Participants
tablets; orally; daily for 15-18 weeks
|
|---|---|---|---|---|
|
Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (Middle 4 Weeks of the 12-week Maintenance Period).
≥ 25% reduction
|
64.2 Percent Responders
|
65.5 Percent Responders
|
75.5 Percent Responders
|
50.9 Percent Responders
|
|
Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (Middle 4 Weeks of the 12-week Maintenance Period).
≥ 50% reduction
|
43.4 Percent Responders
|
51.7 Percent Responders
|
71.4 Percent Responders
|
24.6 Percent Responders
|
|
Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (Middle 4 Weeks of the 12-week Maintenance Period).
≥ 75% reduction
|
28.3 Percent Responders
|
34.5 Percent Responders
|
59.2 Percent Responders
|
12.3 Percent Responders
|
|
Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (Middle 4 Weeks of the 12-week Maintenance Period).
100% reduction
|
9.4 Percent Responders
|
15.5 Percent Responders
|
26.5 Percent Responders
|
5.3 Percent Responders
|
SECONDARY outcome
Timeframe: 4-week baseline period and the last 4 weeks of the 12-week maintenance periodNumber of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.
Outcome measures
| Measure |
Clobazam Low Dose
n=53 Participants
0.25 mg/kg/day; tablets; orally; for 15-18 weeks
|
Clobazam Medium Dose
n=58 Participants
0.5 mg/kg/day; tablets; orally; for 15-18 weeks
|
Clobazam High Dose
n=49 Participants
1.0 mg/kg/day; tablets; orally; for 15-18 weeks
|
Placebo
n=57 Participants
tablets; orally; daily for 15-18 weeks
|
|---|---|---|---|---|
|
Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (Last 4 Weeks of the 12-week Maintenance Period).
≥ 25% reduction
|
66.0 Percent Responders
|
60.3 Percent Responders
|
71.4 Percent Responders
|
43.9 Percent Responders
|
|
Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (Last 4 Weeks of the 12-week Maintenance Period).
≥ 50% reduction
|
45.3 Percent Responders
|
50.0 Percent Responders
|
67.3 Percent Responders
|
29.8 Percent Responders
|
|
Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (Last 4 Weeks of the 12-week Maintenance Period).
≥ 75% reduction
|
28.3 Percent Responders
|
36.2 Percent Responders
|
57.1 Percent Responders
|
12.3 Percent Responders
|
|
Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (Last 4 Weeks of the 12-week Maintenance Period).
100% reduction
|
13.2 Percent Responders
|
15.5 Percent Responders
|
20.4 Percent Responders
|
5.3 Percent Responders
|
SECONDARY outcome
Timeframe: 4-week baseline period and first 4/first 8 weeks of the maintenance periodPopulation: MITT
Study responders who have ≥50% reduction in their drop seizure rate during the first 4 or first 8 weeks of maintenance compared to the 4 week baseline period.
Outcome measures
| Measure |
Clobazam Low Dose
n=53 Participants
0.25 mg/kg/day; tablets; orally; for 15-18 weeks
|
Clobazam Medium Dose
n=58 Participants
0.5 mg/kg/day; tablets; orally; for 15-18 weeks
|
Clobazam High Dose
n=49 Participants
1.0 mg/kg/day; tablets; orally; for 15-18 weeks
|
Placebo
n=57 Participants
tablets; orally; daily for 15-18 weeks
|
|---|---|---|---|---|
|
Tolerance
≥ 50% reduction - first 8 weeks of maintenance
|
23 Participants
|
38 Participants
|
38 Participants
|
20 Participants
|
|
Tolerance
≥ 50% reduction - first 4 weeks of maintenance
|
25 Participants
|
42 Participants
|
38 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Week 15Population: Those patients in the MITT population who completed a Physician Global Evaluation at Week 15.
The physician was asked to rate the patient's overall change in symptoms and overall change in seizure activity and Quality of Life since the beginning of clobazam treatment by checking "very much improved", "much improved", "minimally improved", "no change", "minimally worse", "much worse", or "very much worse".
Outcome measures
| Measure |
Clobazam Low Dose
n=52 Participants
0.25 mg/kg/day; tablets; orally; for 15-18 weeks
|
Clobazam Medium Dose
n=57 Participants
0.5 mg/kg/day; tablets; orally; for 15-18 weeks
|
Clobazam High Dose
n=49 Participants
1.0 mg/kg/day; tablets; orally; for 15-18 weeks
|
Placebo
n=55 Participants
tablets; orally; daily for 15-18 weeks
|
|---|---|---|---|---|
|
Investigator Global Evaluations of the Patient's Overall Change in Symptoms.
No change
|
12 participants
|
9 participants
|
6 participants
|
22 participants
|
|
Investigator Global Evaluations of the Patient's Overall Change in Symptoms.
Very much improved
|
4 participants
|
10 participants
|
8 participants
|
3 participants
|
|
Investigator Global Evaluations of the Patient's Overall Change in Symptoms.
Much improved
|
20 participants
|
27 participants
|
23 participants
|
10 participants
|
|
Investigator Global Evaluations of the Patient's Overall Change in Symptoms.
Minimally improved
|
13 participants
|
9 participants
|
8 participants
|
13 participants
|
|
Investigator Global Evaluations of the Patient's Overall Change in Symptoms.
Minimally worse
|
2 participants
|
2 participants
|
3 participants
|
6 participants
|
|
Investigator Global Evaluations of the Patient's Overall Change in Symptoms.
Much worse
|
1 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Investigator Global Evaluations of the Patient's Overall Change in Symptoms.
Very much worse
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Week 15Population: Those patients in the MITT population who had a baseline and Week 15 parent/caregiver global evaluations were analyzed.
The parent/caregiver was asked to rate the patient's overall change in symptoms and overall change in seizure activity and Quality of Life since the beginning of clobazam treatment by checking "very much improved", "much improved", "minimally improved", "no change", "minimally worse", "much worse", or "very much worse".
Outcome measures
| Measure |
Clobazam Low Dose
n=53 Participants
0.25 mg/kg/day; tablets; orally; for 15-18 weeks
|
Clobazam Medium Dose
n=57 Participants
0.5 mg/kg/day; tablets; orally; for 15-18 weeks
|
Clobazam High Dose
n=49 Participants
1.0 mg/kg/day; tablets; orally; for 15-18 weeks
|
Placebo
n=55 Participants
tablets; orally; daily for 15-18 weeks
|
|---|---|---|---|---|
|
Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms.
Very much improved
|
8 participants
|
13 participants
|
11 participants
|
4 participants
|
|
Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms.
Much improved
|
14 participants
|
19 participants
|
18 participants
|
10 participants
|
|
Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms.
Minimally improved
|
20 participants
|
14 participants
|
11 participants
|
11 participants
|
|
Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms.
No change
|
8 participants
|
7 participants
|
4 participants
|
21 participants
|
|
Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms.
Minimally worse
|
2 participants
|
2 participants
|
3 participants
|
6 participants
|
|
Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms.
Much worse
|
0 participants
|
2 participants
|
2 participants
|
3 participants
|
|
Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms.
Very much worse
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4-week baseline period and the 12-week maintenance periodThis outcome measure evaluated the percent reduction (average per week) in non-drop Seizures. Non-drop seizures were other seizures not meeting the drop seizure definition. Drop seizures were defined as a drop attack or spell (atonic, tonic or myoclonic) involving the entire body, trunk, or head that led to a fall, injury, slumping in chair, or head hitting surface or that could have led to a fall or injury, depending on the position of the patient at the time of the attack or spell.
Outcome measures
| Measure |
Clobazam Low Dose
n=53 Participants
0.25 mg/kg/day; tablets; orally; for 15-18 weeks
|
Clobazam Medium Dose
n=58 Participants
0.5 mg/kg/day; tablets; orally; for 15-18 weeks
|
Clobazam High Dose
n=49 Participants
1.0 mg/kg/day; tablets; orally; for 15-18 weeks
|
Placebo
n=57 Participants
tablets; orally; daily for 15-18 weeks
|
|---|---|---|---|---|
|
Percent Reduction in the Number of Non-drop Seizures.
|
-53.3 Percent reduction
Interval -1627.0 to 100.0
|
-3.3 Percent reduction
Interval -1591.0 to 100.0
|
40.0 Percent reduction
Interval -190.0 to 100.0
|
-76.3 Percent reduction
Interval -1477.0 to 97.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4-week baseline period and 12-week maintenance periodThis outcome measure evaluated the percent reduction in average weekly rate in total (drop and non-drop) seizures. Drop seizures were defined as a drop attack or spell (atonic, tonic or myoclonic) involving the entire body, trunk, or head that led to a fall, injury, slumping in chair, or head hitting surface or that could have led to a fall or injury, depending on the position of the patient at the time of the attack or spell. Non-drop seizures were other seizures not meeting the drop seizure definition.
Outcome measures
| Measure |
Clobazam Low Dose
n=53 Participants
0.25 mg/kg/day; tablets; orally; for 15-18 weeks
|
Clobazam Medium Dose
n=58 Participants
0.5 mg/kg/day; tablets; orally; for 15-18 weeks
|
Clobazam High Dose
n=49 Participants
1.0 mg/kg/day; tablets; orally; for 15-18 weeks
|
Placebo
n=57 Participants
tablets; orally; daily for 15-18 weeks
|
|---|---|---|---|---|
|
Percent Reduction of Total (Drop and Non-Drop) Seizures.
|
34.8 Percent reduction
Interval -155.0 to 100.0
|
45.3 Percent reduction
Interval -523.0 to 100.0
|
65.3 Percent reduction
Interval -49.0 to 100.0
|
9.3 Percent reduction
Interval -189.0 to 100.0
|
Adverse Events
Clobazam Low Dose
Serious events: 3 serious events
Other events: 42 other events
Deaths: 0 deaths
Clobazam Medium Dose
Serious events: 6 serious events
Other events: 55 other events
Deaths: 0 deaths
Clobazam High Dose
Serious events: 5 serious events
Other events: 45 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Clobazam Low Dose
n=58 participants at risk
0.25 mg/kg/day; tablets; orally; for 15-18 weeks
|
Clobazam Medium Dose
n=62 participants at risk
0.5 mg/kg/day; tablets; orally; for 15-18 weeks
|
Clobazam High Dose
n=59 participants at risk
1.0 mg/kg/day; tablets; orally; for 15-18 weeks
|
Placebo
n=59 participants at risk
tablets; orally; daily for 15-18 weeks
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.00%
0/58 • 19 weeks
|
0.00%
0/62 • 19 weeks
|
0.00%
0/59 • 19 weeks
|
1.7%
1/59 • 19 weeks
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/58 • 19 weeks
|
0.00%
0/62 • 19 weeks
|
3.4%
2/59 • 19 weeks
|
1.7%
1/59 • 19 weeks
|
|
General disorders
Adverse drug reaction
|
1.7%
1/58 • 19 weeks
|
0.00%
0/62 • 19 weeks
|
0.00%
0/59 • 19 weeks
|
0.00%
0/59 • 19 weeks
|
|
Nervous system disorders
Sedation
|
1.7%
1/58 • 19 weeks
|
0.00%
0/62 • 19 weeks
|
0.00%
0/59 • 19 weeks
|
0.00%
0/59 • 19 weeks
|
|
Infections and infestations
Metapneumovirus infection
|
1.7%
1/58 • 19 weeks
|
0.00%
0/62 • 19 weeks
|
0.00%
0/59 • 19 weeks
|
0.00%
0/59 • 19 weeks
|
|
Infections and infestations
Pneumonia
|
3.4%
2/58 • 19 weeks
|
3.2%
2/62 • 19 weeks
|
1.7%
1/59 • 19 weeks
|
0.00%
0/59 • 19 weeks
|
|
Infections and infestations
Rhinovirus infection
|
1.7%
1/58 • 19 weeks
|
0.00%
0/62 • 19 weeks
|
0.00%
0/59 • 19 weeks
|
0.00%
0/59 • 19 weeks
|
|
Cardiac disorders
Cyanosis
|
0.00%
0/58 • 19 weeks
|
1.6%
1/62 • 19 weeks
|
0.00%
0/59 • 19 weeks
|
0.00%
0/59 • 19 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/58 • 19 weeks
|
1.6%
1/62 • 19 weeks
|
0.00%
0/59 • 19 weeks
|
0.00%
0/59 • 19 weeks
|
|
Injury, poisoning and procedural complications
Drug administration error
|
0.00%
0/58 • 19 weeks
|
1.6%
1/62 • 19 weeks
|
0.00%
0/59 • 19 weeks
|
0.00%
0/59 • 19 weeks
|
|
Injury, poisoning and procedural complications
Drug toxicity
|
0.00%
0/58 • 19 weeks
|
1.6%
1/62 • 19 weeks
|
0.00%
0/59 • 19 weeks
|
0.00%
0/59 • 19 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/58 • 19 weeks
|
1.6%
1/62 • 19 weeks
|
0.00%
0/59 • 19 weeks
|
0.00%
0/59 • 19 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/58 • 19 weeks
|
1.6%
1/62 • 19 weeks
|
0.00%
0/59 • 19 weeks
|
0.00%
0/59 • 19 weeks
|
|
Nervous system disorders
Myoclonic epilepsy
|
0.00%
0/58 • 19 weeks
|
1.6%
1/62 • 19 weeks
|
0.00%
0/59 • 19 weeks
|
0.00%
0/59 • 19 weeks
|
|
Infections and infestations
Influenza
|
0.00%
0/58 • 19 weeks
|
0.00%
0/62 • 19 weeks
|
1.7%
1/59 • 19 weeks
|
0.00%
0/59 • 19 weeks
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/58 • 19 weeks
|
0.00%
0/62 • 19 weeks
|
1.7%
1/59 • 19 weeks
|
0.00%
0/59 • 19 weeks
|
|
Psychiatric disorders
Depressed level of consciousness
|
0.00%
0/58 • 19 weeks
|
0.00%
0/62 • 19 weeks
|
1.7%
1/59 • 19 weeks
|
0.00%
0/59 • 19 weeks
|
|
Nervous system disorders
Grand mal convulsion
|
0.00%
0/58 • 19 weeks
|
0.00%
0/62 • 19 weeks
|
1.7%
1/59 • 19 weeks
|
0.00%
0/59 • 19 weeks
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/58 • 19 weeks
|
0.00%
0/62 • 19 weeks
|
1.7%
1/59 • 19 weeks
|
0.00%
0/59 • 19 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/58 • 19 weeks
|
0.00%
0/62 • 19 weeks
|
1.7%
1/59 • 19 weeks
|
0.00%
0/59 • 19 weeks
|
|
Investigations
Ultrasound abdomen abnormal
|
0.00%
0/58 • 19 weeks
|
0.00%
0/62 • 19 weeks
|
1.7%
1/59 • 19 weeks
|
0.00%
0/59 • 19 weeks
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/58 • 19 weeks
|
0.00%
0/62 • 19 weeks
|
1.7%
1/59 • 19 weeks
|
0.00%
0/59 • 19 weeks
|
Other adverse events
| Measure |
Clobazam Low Dose
n=58 participants at risk
0.25 mg/kg/day; tablets; orally; for 15-18 weeks
|
Clobazam Medium Dose
n=62 participants at risk
0.5 mg/kg/day; tablets; orally; for 15-18 weeks
|
Clobazam High Dose
n=59 participants at risk
1.0 mg/kg/day; tablets; orally; for 15-18 weeks
|
Placebo
n=59 participants at risk
tablets; orally; daily for 15-18 weeks
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
1.7%
1/58 • 19 weeks
|
1.6%
1/62 • 19 weeks
|
10.2%
6/59 • 19 weeks
|
0.00%
0/59 • 19 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
6.9%
4/58 • 19 weeks
|
3.2%
2/62 • 19 weeks
|
5.1%
3/59 • 19 weeks
|
6.8%
4/59 • 19 weeks
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/58 • 19 weeks
|
0.00%
0/62 • 19 weeks
|
5.1%
3/59 • 19 weeks
|
0.00%
0/59 • 19 weeks
|
|
Gastrointestinal disorders
Vomiting
|
8.6%
5/58 • 19 weeks
|
4.8%
3/62 • 19 weeks
|
6.8%
4/59 • 19 weeks
|
5.1%
3/59 • 19 weeks
|
|
General disorders
Fatigue
|
5.2%
3/58 • 19 weeks
|
4.8%
3/62 • 19 weeks
|
3.4%
2/59 • 19 weeks
|
1.7%
1/59 • 19 weeks
|
|
General disorders
Irritability
|
3.4%
2/58 • 19 weeks
|
11.3%
7/62 • 19 weeks
|
5.1%
3/59 • 19 weeks
|
5.1%
3/59 • 19 weeks
|
|
General disorders
Pyrexia
|
17.2%
10/58 • 19 weeks
|
9.7%
6/62 • 19 weeks
|
11.9%
7/59 • 19 weeks
|
3.4%
2/59 • 19 weeks
|
|
Infections and infestations
Bronchitis
|
1.7%
1/58 • 19 weeks
|
0.00%
0/62 • 19 weeks
|
5.1%
3/59 • 19 weeks
|
0.00%
0/59 • 19 weeks
|
|
Infections and infestations
Nasopharyngitis
|
8.6%
5/58 • 19 weeks
|
9.7%
6/62 • 19 weeks
|
6.8%
4/59 • 19 weeks
|
10.2%
6/59 • 19 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
10.3%
6/58 • 19 weeks
|
12.9%
8/62 • 19 weeks
|
13.6%
8/59 • 19 weeks
|
10.2%
6/59 • 19 weeks
|
|
Infections and infestations
Urinary tract infection
|
1.7%
1/58 • 19 weeks
|
4.8%
3/62 • 19 weeks
|
5.1%
3/59 • 19 weeks
|
0.00%
0/59 • 19 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
3.4%
2/58 • 19 weeks
|
3.2%
2/62 • 19 weeks
|
3.4%
2/59 • 19 weeks
|
5.1%
3/59 • 19 weeks
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/58 • 19 weeks
|
1.6%
1/62 • 19 weeks
|
3.4%
2/59 • 19 weeks
|
8.5%
5/59 • 19 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/58 • 19 weeks
|
1.6%
1/62 • 19 weeks
|
0.00%
0/59 • 19 weeks
|
5.1%
3/59 • 19 weeks
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
1.7%
1/58 • 19 weeks
|
0.00%
0/62 • 19 weeks
|
3.4%
2/59 • 19 weeks
|
5.1%
3/59 • 19 weeks
|
|
Investigations
Blood bicarbonate decreased
|
1.7%
1/58 • 19 weeks
|
0.00%
0/62 • 19 weeks
|
3.4%
2/59 • 19 weeks
|
5.1%
3/59 • 19 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.4%
2/58 • 19 weeks
|
0.00%
0/62 • 19 weeks
|
6.8%
4/59 • 19 weeks
|
3.4%
2/59 • 19 weeks
|
|
Metabolism and nutrition disorders
Increased appetite
|
1.7%
1/58 • 19 weeks
|
3.2%
2/62 • 19 weeks
|
5.1%
3/59 • 19 weeks
|
0.00%
0/59 • 19 weeks
|
|
Nervous system disorders
Ataxia
|
3.4%
2/58 • 19 weeks
|
1.6%
1/62 • 19 weeks
|
10.2%
6/59 • 19 weeks
|
3.4%
2/59 • 19 weeks
|
|
Nervous system disorders
Drooling
|
0.00%
0/58 • 19 weeks
|
12.9%
8/62 • 19 weeks
|
13.6%
8/59 • 19 weeks
|
3.4%
2/59 • 19 weeks
|
|
Nervous system disorders
Dysarthria
|
1.7%
1/58 • 19 weeks
|
1.6%
1/62 • 19 weeks
|
5.1%
3/59 • 19 weeks
|
0.00%
0/59 • 19 weeks
|
|
Nervous system disorders
Lethargy
|
10.3%
6/58 • 19 weeks
|
4.8%
3/62 • 19 weeks
|
15.3%
9/59 • 19 weeks
|
5.1%
3/59 • 19 weeks
|
|
Nervous system disorders
Psychomotor hyperactivity
|
3.4%
2/58 • 19 weeks
|
3.2%
2/62 • 19 weeks
|
5.1%
3/59 • 19 weeks
|
3.4%
2/59 • 19 weeks
|
|
Nervous system disorders
Sedation
|
1.7%
1/58 • 19 weeks
|
3.2%
2/62 • 19 weeks
|
8.5%
5/59 • 19 weeks
|
3.4%
2/59 • 19 weeks
|
|
Nervous system disorders
Somnolence
|
15.5%
9/58 • 19 weeks
|
24.2%
15/62 • 19 weeks
|
25.4%
15/59 • 19 weeks
|
11.9%
7/59 • 19 weeks
|
|
Nervous system disorders
Tremor
|
1.7%
1/58 • 19 weeks
|
6.5%
4/62 • 19 weeks
|
1.7%
1/59 • 19 weeks
|
0.00%
0/59 • 19 weeks
|
|
Psychiatric disorders
Aggression
|
3.4%
2/58 • 19 weeks
|
8.1%
5/62 • 19 weeks
|
13.6%
8/59 • 19 weeks
|
5.1%
3/59 • 19 weeks
|
|
Psychiatric disorders
Insomnia
|
1.7%
1/58 • 19 weeks
|
4.8%
3/62 • 19 weeks
|
6.8%
4/59 • 19 weeks
|
1.7%
1/59 • 19 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.4%
2/58 • 19 weeks
|
4.8%
3/62 • 19 weeks
|
6.8%
4/59 • 19 weeks
|
0.00%
0/59 • 19 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.2%
3/58 • 19 weeks
|
0.00%
0/62 • 19 weeks
|
1.7%
1/59 • 19 weeks
|
1.7%
1/59 • 19 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.7%
1/58 • 19 weeks
|
3.2%
2/62 • 19 weeks
|
5.1%
3/59 • 19 weeks
|
3.4%
2/59 • 19 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor must have the opportunity to review and approve all proposed abstracts, manuscripts, or presentations regarding this study prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission.
- Publication restrictions are in place
Restriction type: OTHER