Trial Outcomes & Findings for Characterization of Epilepsy Patients BEEP 2b (NCT NCT02707965)
NCT ID: NCT02707965
Last Updated: 2020-03-27
Results Overview
Average AUC (area under the drug plasma curve.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
21 participants
Primary outcome timeframe
For all study drugs, time points are: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, and 6 hr postdose. For twice-a-day regimen, additional points are:8, 10, and 12 hr postdose. For once-a-day drugs, additional times are:8, 10, 12, 16, and 24 hr postdose.
Results posted on
2020-03-27
Participant Flow
Participant milestones
| Measure |
Sequence 1/Topiramate
Subjects received Topiramate in the sequence order 1 (TRRT).
Test-Reference-Reference-Test
Reference: Brand Test: Generic
|
Sequence 2/Topiramate
Subjects received Topiramate in the sequence order 2 (RTTR).
Reference-Test-Test-Reference
Reference: Brand Test: Generic
|
Sequence 1/Lamotrigine
Subjects received Lamotrigine in the sequence order 1 (TRRT).
Test-Reference-Reference-Test
Reference: Brand Test: Generic
|
Sequence 2/Lamotrigine
Subjects received Lamotrigine in the sequence order 2 (RTTR).
Reference-Test-Test-Reference
Reference: Brand Test: Generic
|
Sequence 1/Levetiracetam IR
Subjects received Levetiracetam IR in the sequence order 1 (TRRT).
Test-Reference-Reference-Test
Reference: Brand Test: Generic
|
Sequence 2/Levetiracetam IR
Subjects received Levetiracetam IR in the sequence order 2 (RTTR).
Reference-Test-Test-Reference
Reference: Brand Test: Generic
|
Sequence 1/Carbamazepine ER Tablet
Subjects received Carbamazepine ER tablet in the sequence order 1 (TRRT).
Test-Reference-Reference-Test
Reference: Brand Test: Generic
|
Sequence 2/Carbamazepine ER Tablet
Subjects received Carbamazepine ER tablet in the sequence order 2 (RTTR).
Reference-Test-Test-Reference
Reference: Brand Test: Generic
|
Sequence 1/Carbamazepine ER Capsule
Subjects received Carbamazepine ER capsule in the sequence order 1 (TRRT).
Test-Reference-Reference-Test
Reference: Brand Test: Generic
|
Sequence 2/Carbamazepine ER Capsule
Subjects received Carbamazepine ER capsule in the sequence order 2 (RTTR).
Reference-Test-Test-Reference
Reference: Brand Test: Generic
|
Sequence 1/Zonisamide
Subjects received Zonisamide in the sequence order 1 (TRRT).
Test-Reference-Reference-Test
Reference: Brand Test: Generic
|
Sequence 2/Zonisamide
Subjects received Zonisamide in the sequence order 2 (RTTR).
Reference-Test-Test-Reference
Reference: Brand Test: Generic
|
Sequence 1/Levetiracetam ER
Subjects received Levetiracetam in the sequence order 1 (TRRT).
Test-Reference-Reference-Test
Reference: Brand Test: Generic
|
Sequence 2/Levetiracetam ER
Subjects received Levetiracetam ER in the sequence order 2 (RTTR).
Reference-Test-Test-Reference
Reference: Brand Test: Generic
|
Sequence 1/Valproic Acid
Subjects received Valproic acid in the sequence order 1 (TRRT).
Test-Reference-Reference-Test
Reference: Brand Test: Generic
|
Sequence 2/Valproic Acid
Subjects received Valproic acid in the sequence order 2 (RTTR).
Reference-Test-Test-Reference
Reference: Brand Test: Generic
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
2
|
4
|
0
|
2
|
1
|
0
|
3
|
1
|
0
|
1
|
0
|
0
|
2
|
2
|
0
|
|
Overall Study
COMPLETED
|
2
|
1
|
3
|
0
|
2
|
1
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
2
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
0
|
0
|
0
|
0
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
Reasons for withdrawal
| Measure |
Sequence 1/Topiramate
Subjects received Topiramate in the sequence order 1 (TRRT).
Test-Reference-Reference-Test
Reference: Brand Test: Generic
|
Sequence 2/Topiramate
Subjects received Topiramate in the sequence order 2 (RTTR).
Reference-Test-Test-Reference
Reference: Brand Test: Generic
|
Sequence 1/Lamotrigine
Subjects received Lamotrigine in the sequence order 1 (TRRT).
Test-Reference-Reference-Test
Reference: Brand Test: Generic
|
Sequence 2/Lamotrigine
Subjects received Lamotrigine in the sequence order 2 (RTTR).
Reference-Test-Test-Reference
Reference: Brand Test: Generic
|
Sequence 1/Levetiracetam IR
Subjects received Levetiracetam IR in the sequence order 1 (TRRT).
Test-Reference-Reference-Test
Reference: Brand Test: Generic
|
Sequence 2/Levetiracetam IR
Subjects received Levetiracetam IR in the sequence order 2 (RTTR).
Reference-Test-Test-Reference
Reference: Brand Test: Generic
|
Sequence 1/Carbamazepine ER Tablet
Subjects received Carbamazepine ER tablet in the sequence order 1 (TRRT).
Test-Reference-Reference-Test
Reference: Brand Test: Generic
|
Sequence 2/Carbamazepine ER Tablet
Subjects received Carbamazepine ER tablet in the sequence order 2 (RTTR).
Reference-Test-Test-Reference
Reference: Brand Test: Generic
|
Sequence 1/Carbamazepine ER Capsule
Subjects received Carbamazepine ER capsule in the sequence order 1 (TRRT).
Test-Reference-Reference-Test
Reference: Brand Test: Generic
|
Sequence 2/Carbamazepine ER Capsule
Subjects received Carbamazepine ER capsule in the sequence order 2 (RTTR).
Reference-Test-Test-Reference
Reference: Brand Test: Generic
|
Sequence 1/Zonisamide
Subjects received Zonisamide in the sequence order 1 (TRRT).
Test-Reference-Reference-Test
Reference: Brand Test: Generic
|
Sequence 2/Zonisamide
Subjects received Zonisamide in the sequence order 2 (RTTR).
Reference-Test-Test-Reference
Reference: Brand Test: Generic
|
Sequence 1/Levetiracetam ER
Subjects received Levetiracetam in the sequence order 1 (TRRT).
Test-Reference-Reference-Test
Reference: Brand Test: Generic
|
Sequence 2/Levetiracetam ER
Subjects received Levetiracetam ER in the sequence order 2 (RTTR).
Reference-Test-Test-Reference
Reference: Brand Test: Generic
|
Sequence 1/Valproic Acid
Subjects received Valproic acid in the sequence order 1 (TRRT).
Test-Reference-Reference-Test
Reference: Brand Test: Generic
|
Sequence 2/Valproic Acid
Subjects received Valproic acid in the sequence order 2 (RTTR).
Reference-Test-Test-Reference
Reference: Brand Test: Generic
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
PI decisions
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
|
Overall Study
Protocol deviation
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Characterization of Epilepsy Patients BEEP 2b
Baseline characteristics by cohort
| Measure |
Topiramate Tablet Group
n=5 Participants
All subjects who received the Topiramate Tablet.
|
Lamotrigine IR Tablet Group
n=1 Participants
All subjects who received the Lamotrigine IR Tablet.
|
Lamotrigine ER Tablet Group
n=3 Participants
All subjects who received the Lamotrigine ER Tablet.
|
Levetiracetam IR Tablet Group
n=3 Participants
All subjects who received the Levetiracetam IR Tablet.
|
Levetiracetam ER Tablet Group
n=2 Participants
All subjects who received the Levetiracetam ER Tablet.
|
Carbamazepine ER Capsule
n=2 Participants
All subjects who received the Carbamazepine ER Capsule.
|
Carbamazepine ER Tablet
n=1 Participants
All subjects who received the Carbamazepine ER Tablet.
|
Zonisamide Capsule Group
n=1 Participants
All subjects who received the Zonisamide Capsule.
|
Valproic Acid ER Tablet Group
n=2 Participants
All subjects who received the Valproic Acid ER Tablet.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
20 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
18 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
2 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
1 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
19 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 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
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
11 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: For all study drugs, time points are: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, and 6 hr postdose. For twice-a-day regimen, additional points are:8, 10, and 12 hr postdose. For once-a-day drugs, additional times are:8, 10, 12, 16, and 24 hr postdose.Average AUC (area under the drug plasma curve.
Outcome measures
| Measure |
Topiramate Tablet
n=5 Participants
Subjects who received Topiramate for Sequence 1 and 2.
|
Lamotrigine ER Tablet
n=3 Participants
Subjects who received Lamotrigine ER for Sequence 1 and 2.
|
Levetiracetam IR Tablet
n=3 Participants
Subjects who received Levetiracetam IR for Sequence 1 and 2.
|
Levetiracetam ER Tablet
n=2 Participants
Subjects who received Levetiracetam ER for Sequence 1 and 2.
|
Carbamazepine ER Capsule
n=1 Participants
Subjects who received Carbamazepine ER Capsule for Sequence 1 and 2.
|
Carbamazepine ER Tablet
n=1 Participants
Subjects who received Carbamazepine ER Tablet for Sequence 1 and 2.
|
Zonisamide Capsule
n=1 Participants
Subjects who received Zonisamide for Sequence 1 and 2.
|
Valproic Acid
Subjects who received Valproic acid for Sequence 1 and 2.
|
Valproic Acid ER Tablet Group
All subjects who received the Valproic Acid ER Tablet.
|
|---|---|---|---|---|---|---|---|---|---|
|
Mean AUC0-last_ss (Test vs. Reference)
Test Product
|
92.884 micro/mL/hr
Standard Deviation 45.04955804
|
62.76666667 micro/mL/hr
Standard Deviation 26.51919556
|
419.97 micro/mL/hr
Standard Deviation 116.7864209
|
260.3 micro/mL/hr
Standard Deviation 169.1399421
|
114.96 micro/mL/hr
Standard Deviation 0
|
104.6 micro/mL/hr
Standard Deviation 0
|
233.16 micro/mL/hr
Standard Deviation 0
|
—
|
—
|
|
Mean AUC0-last_ss (Test vs. Reference)
Reference Product
|
94.456 micro/mL/hr
Standard Deviation 46.91455403
|
67.19333333 micro/mL/hr
Standard Deviation 28.83182501
|
445.2 micro/mL/hr
Standard Deviation 125.97458
|
262.305 micro/mL/hr
Standard Deviation 176.4584972
|
106.45 micro/mL/hr
Standard Deviation 0
|
115.16 micro/mL/hr
Standard Deviation 0
|
226.14 micro/mL/hr
Standard Deviation 0
|
—
|
—
|
PRIMARY outcome
Timeframe: For all study drugs, time points are: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, and 6 hr postdose. For twice-a-day regimen, additional points are:8, 10, and 12 hr postdose. For once-a-day drugs, additional times are:8, 10, 12, 16, and 24 hr postdose.Average maximum drug plasma concentration;
Outcome measures
| Measure |
Topiramate Tablet
n=5 Participants
Subjects who received Topiramate for Sequence 1 and 2.
|
Lamotrigine ER Tablet
n=3 Participants
Subjects who received Lamotrigine ER for Sequence 1 and 2.
|
Levetiracetam IR Tablet
n=3 Participants
Subjects who received Levetiracetam IR for Sequence 1 and 2.
|
Levetiracetam ER Tablet
n=2 Participants
Subjects who received Levetiracetam ER for Sequence 1 and 2.
|
Carbamazepine ER Capsule
n=1 Participants
Subjects who received Carbamazepine ER Capsule for Sequence 1 and 2.
|
Carbamazepine ER Tablet
n=1 Participants
Subjects who received Carbamazepine ER Tablet for Sequence 1 and 2.
|
Zonisamide Capsule
n=1 Participants
Subjects who received Zonisamide for Sequence 1 and 2.
|
Valproic Acid
Subjects who received Valproic acid for Sequence 1 and 2.
|
Valproic Acid ER Tablet Group
All subjects who received the Valproic Acid ER Tablet.
|
|---|---|---|---|---|---|---|---|---|---|
|
Mean Cmax_ss (Test vs. Reference)
Test Product
|
9.874 microg/mL
Standard Deviation 4.889389532
|
6.24 microg/mL
Standard Deviation 2.327853088
|
71.02333333 microg/mL
Standard Deviation 16.29206658
|
31.05 microg/mL
Standard Deviation 16.64529363
|
10.95 microg/mL
Standard Deviation 0
|
10.00 microg/mL
Standard Deviation 0
|
12.29 microg/mL
Standard Deviation 0
|
—
|
—
|
|
Mean Cmax_ss (Test vs. Reference)
Reference Product
|
9.646 microg/mL
Standard Deviation 4.834328288
|
6.903333333 microg/mL
Standard Deviation 2.460819647
|
69.29333333 microg/mL
Standard Deviation 15.89970545
|
28.04 microg/mL
Standard Deviation 17.2675476
|
9.91 microg/mL
Standard Deviation 0
|
10.6 microg/mL
Standard Deviation 0
|
11.68 microg/mL
Standard Deviation 0
|
—
|
—
|
PRIMARY outcome
Timeframe: For all study drugs, time points are: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, and 6 hr postdose. For twice-a-day regimen, additional points are:8, 10, and 12 hr postdose. For once-a-day drugs, additional times are:8, 10, 12, 16, and 24 hr postdose.Average minimum drug plasma concentration (Cmin);
Outcome measures
| Measure |
Topiramate Tablet
n=5 Participants
Subjects who received Topiramate for Sequence 1 and 2.
|
Lamotrigine ER Tablet
n=3 Participants
Subjects who received Lamotrigine ER for Sequence 1 and 2.
|
Levetiracetam IR Tablet
n=3 Participants
Subjects who received Levetiracetam IR for Sequence 1 and 2.
|
Levetiracetam ER Tablet
n=2 Participants
Subjects who received Levetiracetam ER for Sequence 1 and 2.
|
Carbamazepine ER Capsule
n=1 Participants
Subjects who received Carbamazepine ER Capsule for Sequence 1 and 2.
|
Carbamazepine ER Tablet
n=1 Participants
Subjects who received Carbamazepine ER Tablet for Sequence 1 and 2.
|
Zonisamide Capsule
n=1 Participants
Subjects who received Zonisamide for Sequence 1 and 2.
|
Valproic Acid
Subjects who received Valproic acid for Sequence 1 and 2.
|
Valproic Acid ER Tablet Group
All subjects who received the Valproic Acid ER Tablet.
|
|---|---|---|---|---|---|---|---|---|---|
|
Mean Cmin_ss (Test vs. Reference)
Test Product
|
6.326 microg/mL
Standard Deviation 2.990924606
|
4.053333333 microg/mL
Standard Deviation 1.569214241
|
15.45333333 microg/mL
Standard Deviation 4.702981324
|
12.605 microg/mL
Standard Deviation 12.21173411
|
8.56 microg/mL
Standard Deviation 0
|
7.37 microg/mL
Standard Deviation 0
|
8.46 microg/mL
Standard Deviation 0
|
—
|
—
|
|
Mean Cmin_ss (Test vs. Reference)
Reference Product
|
6.53 microg/mL
Standard Deviation 3.261203765
|
4.21 microg/mL
Standard Deviation 2.343736333
|
17.45666667 microg/mL
Standard Deviation 6.150612436
|
14.395 microg/mL
Standard Deviation 12.40972401
|
7.66 microg/mL
Standard Deviation 0
|
7.97 microg/mL
Standard Deviation 0
|
8.34 microg/mL
Standard Deviation 0
|
—
|
—
|
SECONDARY outcome
Timeframe: Through the approximately 2 week period when the treatment is given.summed for each anti-epileptic drug from when taking brand and generic.
Outcome measures
| Measure |
Topiramate Tablet
n=5 Participants
Subjects who received Topiramate for Sequence 1 and 2.
|
Lamotrigine ER Tablet
n=4 Participants
Subjects who received Lamotrigine ER for Sequence 1 and 2.
|
Levetiracetam IR Tablet
n=3 Participants
Subjects who received Levetiracetam IR for Sequence 1 and 2.
|
Levetiracetam ER Tablet
n=2 Participants
Subjects who received Levetiracetam ER for Sequence 1 and 2.
|
Carbamazepine ER Capsule
n=3 Participants
Subjects who received Carbamazepine ER Capsule for Sequence 1 and 2.
|
Carbamazepine ER Tablet
n=1 Participants
Subjects who received Carbamazepine ER Tablet for Sequence 1 and 2.
|
Zonisamide Capsule
n=1 Participants
Subjects who received Zonisamide for Sequence 1 and 2.
|
Valproic Acid
n=2 Participants
Subjects who received Valproic acid for Sequence 1 and 2.
|
Valproic Acid ER Tablet Group
All subjects who received the Valproic Acid ER Tablet.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Adverse Events
|
29 events
|
9 events
|
17 events
|
4 events
|
15 events
|
6 events
|
10 events
|
10 events
|
—
|
SECONDARY outcome
Timeframe: Through the approximately 2 week period when the treatment is given.Number of seizures reported in all groups
Outcome measures
| Measure |
Topiramate Tablet
n=5 Participants
Subjects who received Topiramate for Sequence 1 and 2.
|
Lamotrigine ER Tablet
n=1 Participants
Subjects who received Lamotrigine ER for Sequence 1 and 2.
|
Levetiracetam IR Tablet
n=3 Participants
Subjects who received Levetiracetam IR for Sequence 1 and 2.
|
Levetiracetam ER Tablet
n=3 Participants
Subjects who received Levetiracetam ER for Sequence 1 and 2.
|
Carbamazepine ER Capsule
n=2 Participants
Subjects who received Carbamazepine ER Capsule for Sequence 1 and 2.
|
Carbamazepine ER Tablet
n=2 Participants
Subjects who received Carbamazepine ER Tablet for Sequence 1 and 2.
|
Zonisamide Capsule
n=1 Participants
Subjects who received Zonisamide for Sequence 1 and 2.
|
Valproic Acid
n=1 Participants
Subjects who received Valproic acid for Sequence 1 and 2.
|
Valproic Acid ER Tablet Group
n=2 Participants
All subjects who received the Valproic Acid ER Tablet.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Seizures Reported
Test (Generic)
|
5 Number of Seizures
|
0 Number of Seizures
|
25 Number of Seizures
|
5 Number of Seizures
|
72 Number of Seizures
|
1 Number of Seizures
|
0 Number of Seizures
|
0 Number of Seizures
|
0 Number of Seizures
|
|
Number of Seizures Reported
Reference Product
|
9 Number of Seizures
|
0 Number of Seizures
|
44 Number of Seizures
|
16 Number of Seizures
|
42 Number of Seizures
|
3 Number of Seizures
|
0 Number of Seizures
|
0 Number of Seizures
|
12 Number of Seizures
|
Adverse Events
Topiramate
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Lamotrigine ER
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Levetiracetam IR
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Levetiracetam ER
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Carbamazepine ER Capsule
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Zonisamide
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Carbamazepine ER Tablet
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Valproic Acid
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Topiramate
n=5 participants at risk
Subjects who received Topiramate for Sequence 1 and 2.
|
Lamotrigine ER
n=4 participants at risk；n=3 participants at risk
Subjects who received Lamotrigine ER for Sequence 1 and 2.
|
Levetiracetam IR
n=3 participants at risk
Subjects who received Levetiracetam IR for Sequence 1 and 2.
|
Levetiracetam ER
n=2 participants at risk
Subjects who received Levetiracetam ER for Sequence 1 and 2.
|
Carbamazepine ER Capsule
n=3 participants at risk；n=1 participants at risk
Subjects who received Carbamazepine ER Capsule for Sequence 1 and 2.
|
Zonisamide
n=1 participants at risk
Subjects who received Zonisamide for Sequence 1 and 2.
|
Carbamazepine ER Tablet
n=1 participants at risk
Subjects who received Carbamazepine ER Tablet for Sequence 1 and 2.
|
Valproic Acid
n=2 participants at risk
Subjects who received Valproic acid for Sequence 1 and 2.
|
|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Worsening of aphrasia
|
20.0%
1/5 • Number of events 2 • Approximately 16 weeks per subject
|
0.00%
0/4 • Approximately 16 weeks per subject
|
0.00%
0/3 • Approximately 16 weeks per subject
|
0.00%
0/2 • Approximately 16 weeks per subject
|
0.00%
0/3 • Approximately 16 weeks per subject
|
0.00%
0/1 • Approximately 16 weeks per subject
|
0.00%
0/1 • Approximately 16 weeks per subject
|
0.00%
0/2 • Approximately 16 weeks per subject
|
|
Psychiatric disorders
Insomnia
|
20.0%
1/5 • Number of events 1 • Approximately 16 weeks per subject
|
0.00%
0/4 • Approximately 16 weeks per subject
|
0.00%
0/3 • Approximately 16 weeks per subject
|
0.00%
0/2 • Approximately 16 weeks per subject
|
0.00%
0/3 • Approximately 16 weeks per subject
|
100.0%
1/1 • Number of events 1 • Approximately 16 weeks per subject
|
0.00%
0/1 • Approximately 16 weeks per subject
|
0.00%
0/2 • Approximately 16 weeks per subject
|
|
General disorders
Fatigue
|
40.0%
2/5 • Number of events 3 • Approximately 16 weeks per subject
|
25.0%
1/4 • Number of events 2 • Approximately 16 weeks per subject
|
33.3%
1/3 • Number of events 4 • Approximately 16 weeks per subject
|
50.0%
1/2 • Number of events 1 • Approximately 16 weeks per subject
|
33.3%
1/3 • Number of events 2 • Approximately 16 weeks per subject
|
0.00%
0/1 • Approximately 16 weeks per subject
|
100.0%
1/1 • Number of events 3 • Approximately 16 weeks per subject
|
0.00%
0/2 • Approximately 16 weeks per subject
|
|
Nervous system disorders
Somnolence
|
20.0%
1/5 • Number of events 3 • Approximately 16 weeks per subject
|
25.0%
1/4 • Number of events 1 • Approximately 16 weeks per subject
|
33.3%
1/3 • Number of events 4 • Approximately 16 weeks per subject
|
50.0%
1/2 • Number of events 2 • Approximately 16 weeks per subject
|
33.3%
1/3 • Number of events 1 • Approximately 16 weeks per subject
|
0.00%
0/1 • Approximately 16 weeks per subject
|
100.0%
1/1 • Number of events 3 • Approximately 16 weeks per subject
|
0.00%
0/2 • Approximately 16 weeks per subject
|
|
Nervous system disorders
Headache
|
60.0%
3/5 • Number of events 4 • Approximately 16 weeks per subject
|
50.0%
2/4 • Number of events 2 • Approximately 16 weeks per subject
|
33.3%
1/3 • Number of events 2 • Approximately 16 weeks per subject
|
50.0%
1/2 • Number of events 1 • Approximately 16 weeks per subject
|
33.3%
1/3 • Number of events 2 • Approximately 16 weeks per subject
|
100.0%
1/1 • Number of events 1 • Approximately 16 weeks per subject
|
100.0%
1/1 • Number of events 2 • Approximately 16 weeks per subject
|
50.0%
1/2 • Number of events 1 • Approximately 16 weeks per subject
|
|
Gastrointestinal disorders
Nausea
|
20.0%
1/5 • Number of events 1 • Approximately 16 weeks per subject
|
0.00%
0/4 • Approximately 16 weeks per subject
|
0.00%
0/3 • Approximately 16 weeks per subject
|
0.00%
0/2 • Approximately 16 weeks per subject
|
33.3%
1/3 • Number of events 1 • Approximately 16 weeks per subject
|
0.00%
0/1 • Approximately 16 weeks per subject
|
0.00%
0/1 • Approximately 16 weeks per subject
|
0.00%
0/2 • Approximately 16 weeks per subject
|
|
Psychiatric disorders
Psychosis
|
0.00%
0/5 • Approximately 16 weeks per subject
|
0.00%
0/4 • Approximately 16 weeks per subject
|
0.00%
0/3 • Approximately 16 weeks per subject
|
0.00%
0/2 • Approximately 16 weeks per subject
|
33.3%
1/3 • Number of events 2 • Approximately 16 weeks per subject
|
0.00%
0/1 • Approximately 16 weeks per subject
|
0.00%
0/1 • Approximately 16 weeks per subject
|
0.00%
0/2 • Approximately 16 weeks per subject
|
|
Nervous system disorders
Dizziness
|
40.0%
2/5 • Number of events 2 • Approximately 16 weeks per subject
|
0.00%
0/4 • Approximately 16 weeks per subject
|
33.3%
1/3 • Number of events 2 • Approximately 16 weeks per subject
|
0.00%
0/2 • Approximately 16 weeks per subject
|
33.3%
1/3 • Number of events 2 • Approximately 16 weeks per subject
|
0.00%
0/1 • Approximately 16 weeks per subject
|
100.0%
1/1 • Number of events 1 • Approximately 16 weeks per subject
|
0.00%
0/2 • Approximately 16 weeks per subject
|
|
Psychiatric disorders
Irritability
|
20.0%
1/5 • Number of events 1 • Approximately 16 weeks per subject
|
0.00%
0/4 • Approximately 16 weeks per subject
|
33.3%
1/3 • Number of events 1 • Approximately 16 weeks per subject
|
0.00%
0/2 • Approximately 16 weeks per subject
|
0.00%
0/3 • Approximately 16 weeks per subject
|
0.00%
0/1 • Approximately 16 weeks per subject
|
0.00%
0/1 • Approximately 16 weeks per subject
|
0.00%
0/2 • Approximately 16 weeks per subject
|
|
Gastrointestinal disorders
Dyspepsia
|
20.0%
1/5 • Number of events 2 • Approximately 16 weeks per subject
|
0.00%
0/4 • Approximately 16 weeks per subject
|
0.00%
0/3 • Approximately 16 weeks per subject
|
0.00%
0/2 • Approximately 16 weeks per subject
|
0.00%
0/3 • Approximately 16 weeks per subject
|
0.00%
0/1 • Approximately 16 weeks per subject
|
0.00%
0/1 • Approximately 16 weeks per subject
|
0.00%
0/2 • Approximately 16 weeks per subject
|
|
Psychiatric disorders
Mood swing
|
20.0%
1/5 • Number of events 2 • Approximately 16 weeks per subject
|
0.00%
0/4 • Approximately 16 weeks per subject
|
0.00%
0/3 • Approximately 16 weeks per subject
|
0.00%
0/2 • Approximately 16 weeks per subject
|
0.00%
0/3 • Approximately 16 weeks per subject
|
0.00%
0/1 • Approximately 16 weeks per subject
|
0.00%
0/1 • Approximately 16 weeks per subject
|
0.00%
0/2 • Approximately 16 weeks per subject
|
|
Nervous system disorders
Tremor
|
0.00%
0/5 • Approximately 16 weeks per subject
|
0.00%
0/4 • Approximately 16 weeks per subject
|
0.00%
0/3 • Approximately 16 weeks per subject
|
0.00%
0/2 • Approximately 16 weeks per subject
|
33.3%
1/3 • Number of events 1 • Approximately 16 weeks per subject
|
0.00%
0/1 • Approximately 16 weeks per subject
|
0.00%
0/1 • Approximately 16 weeks per subject
|
50.0%
1/2 • Number of events 3 • Approximately 16 weeks per subject
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/5 • Approximately 16 weeks per subject
|
0.00%
0/4 • Approximately 16 weeks per subject
|
0.00%
0/3 • Approximately 16 weeks per subject
|
0.00%
0/2 • Approximately 16 weeks per subject
|
33.3%
1/3 • Number of events 1 • Approximately 16 weeks per subject
|
0.00%
0/1 • Approximately 16 weeks per subject
|
0.00%
0/1 • Approximately 16 weeks per subject
|
50.0%
1/2 • Number of events 1 • Approximately 16 weeks per subject
|
|
Musculoskeletal and connective tissue disorders
Shoulder/arm pain
|
0.00%
0/5 • Approximately 16 weeks per subject
|
0.00%
0/4 • Approximately 16 weeks per subject
|
0.00%
0/3 • Approximately 16 weeks per subject
|
0.00%
0/2 • Approximately 16 weeks per subject
|
33.3%
1/3 • Number of events 1 • Approximately 16 weeks per subject
|
0.00%
0/1 • Approximately 16 weeks per subject
|
0.00%
0/1 • Approximately 16 weeks per subject
|
50.0%
1/2 • Number of events 1 • Approximately 16 weeks per subject
|
|
Injury, poisoning and procedural complications
Fall
|
20.0%
1/5 • Number of events 1 • Approximately 16 weeks per subject
|
25.0%
1/4 • Number of events 1 • Approximately 16 weeks per subject
|
0.00%
0/3 • Approximately 16 weeks per subject
|
0.00%
0/2 • Approximately 16 weeks per subject
|
0.00%
0/3 • Approximately 16 weeks per subject
|
0.00%
0/1 • Approximately 16 weeks per subject
|
0.00%
0/1 • Approximately 16 weeks per subject
|
0.00%
0/2 • Approximately 16 weeks per subject
|
Additional Information
Dr. James Polli
University of Maryland, School of Pharmacy
Phone: 410-706-8292
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place