Trial Outcomes & Findings for The Efficacy and Safety of Low Dose Combination of LTG and VPA Compared to CBZ Monotherapy (NCT NCT00807989)
NCT ID: NCT00807989
Last Updated: 2015-07-27
Results Overview
\* Retention rate means completion rate (CR), the proportion of patients who have completed the 60-week study as planned.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
207 participants
Primary outcome timeframe
52 weeks
Results posted on
2015-07-27
Participant Flow
Participant milestones
| Measure |
Carbamazepine
Carbamazepine 100mg/day for the first two weeks. At next two weeks, dose of Carbamazepine was increased to 200mg/day in two divided doses
|
Lamotrigine/Valproate
Lamotrigine and Valproate combination therapy
Lamotrigine 25mg/day for the first two weeks. At next two weeks, LTG 50 mg once a day
|
|---|---|---|
|
Overall Study
STARTED
|
107
|
100
|
|
Overall Study
COMPLETED
|
104
|
98
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Efficacy and Safety of Low Dose Combination of LTG and VPA Compared to CBZ Monotherapy
Baseline characteristics by cohort
| Measure |
Carbamazepine
n=104 Participants
Carbamazepine
Carbamazepine
|
Lamotrigine/Valproate
n=98 Participants
Lamotrigine and Valproate combination therapy
Lamotrigine/Valproate
|
Total
n=202 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.2 Year
STANDARD_DEVIATION 14.6 • n=39 Participants
|
36.5 Year
STANDARD_DEVIATION 13.7 • n=41 Participants
|
34.8 Year
STANDARD_DEVIATION 14.2 • n=35 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=39 Participants
|
48 Participants
n=41 Participants
|
99 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=39 Participants
|
50 Participants
n=41 Participants
|
103 Participants
n=35 Participants
|
|
Region of Enrollment
Korea, Republic of
|
104 participants
n=39 Participants
|
98 participants
n=41 Participants
|
202 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 52 weeks\* Retention rate means completion rate (CR), the proportion of patients who have completed the 60-week study as planned.
Outcome measures
| Measure |
Carbamazepine
n=104 Participants
Carbamazepine
Carbamazepine
|
Lamotrigine/Valproate
n=98 Participants
Lamotrigine and Valproate combination therapy
Lamotrigine/Valproate
|
|---|---|---|
|
Retention Rate After 52 Weeks Maintenance Period
|
104 participants
|
98 participants
|
SECONDARY outcome
Timeframe: 24 weeksOutcome measures
| Measure |
Carbamazepine
n=90 Participants
Carbamazepine
Carbamazepine
|
Lamotrigine/Valproate
n=78 Participants
Lamotrigine and Valproate combination therapy
Lamotrigine/Valproate
|
|---|---|---|
|
Seizure Free Rate for 24 Weeks at Initial Target Dose
|
51 participants
|
59 participants
|
SECONDARY outcome
Timeframe: 52 weeksOutcome measures
| Measure |
Carbamazepine
n=90 Participants
Carbamazepine
Carbamazepine
|
Lamotrigine/Valproate
n=78 Participants
Lamotrigine and Valproate combination therapy
Lamotrigine/Valproate
|
|---|---|---|
|
Seizure Free Rate for 52 Weeks at Initial Target Dose
|
43 participants
|
50 participants
|
Adverse Events
Carbamazepine
Serious events: 9 serious events
Other events: 60 other events
Deaths: 0 deaths
Lamotrigine/Valproate
Serious events: 0 serious events
Other events: 59 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Carbamazepine
n=104 participants at risk
Carbamazepine
Carbamazepine
|
Lamotrigine/Valproate
n=98 participants at risk
Lamotrigine and Valproate combination therapy
Lamotrigine/Valproate
|
|---|---|---|
|
Infections and infestations
Meningoencephalitis herpetic
|
0.96%
1/104 • Number of events 1 • 52 weeks
|
0.00%
0/98 • 52 weeks
|
|
Infections and infestations
Pneumonia
|
0.96%
1/104 • Number of events 1 • 52 weeks
|
0.00%
0/98 • 52 weeks
|
|
Nervous system disorders
Alcoholic seizure
|
0.96%
1/104 • Number of events 1 • 52 weeks
|
0.00%
0/98 • 52 weeks
|
|
Nervous system disorders
Atonic seizures
|
0.96%
1/104 • Number of events 1 • 52 weeks
|
0.00%
0/98 • 52 weeks
|
|
Cardiac disorders
Ventricular tachycardia
|
0.96%
1/104 • Number of events 1 • 52 weeks
|
0.00%
0/98 • 52 weeks
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.96%
1/104 • Number of events 1 • 52 weeks
|
0.00%
0/98 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Facet joint syndrome
|
0.96%
1/104 • Number of events 1 • 52 weeks
|
0.00%
0/98 • 52 weeks
|
|
Psychiatric disorders
Abnormal behaviour
|
0.96%
1/104 • Number of events 1 • 52 weeks
|
0.00%
0/98 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
0.96%
1/104 • Number of events 1 • 52 weeks
|
0.00%
0/98 • 52 weeks
|
|
Surgical and medical procedures
Hospitalisation
|
0.96%
1/104 • Number of events 1 • 52 weeks
|
0.00%
0/98 • 52 weeks
|
Other adverse events
| Measure |
Carbamazepine
n=104 participants at risk
Carbamazepine
Carbamazepine
|
Lamotrigine/Valproate
n=98 participants at risk
Lamotrigine and Valproate combination therapy
Lamotrigine/Valproate
|
|---|---|---|
|
Nervous system disorders
Headache
|
25.0%
26/104 • Number of events 29 • 52 weeks
|
26.5%
26/98 • Number of events 52 • 52 weeks
|
|
Nervous system disorders
Dizziness
|
17.3%
18/104 • Number of events 23 • 52 weeks
|
17.3%
17/98 • Number of events 18 • 52 weeks
|
|
Nervous system disorders
Somnolence
|
13.5%
14/104 • Number of events 15 • 52 weeks
|
12.2%
12/98 • Number of events 12 • 52 weeks
|
|
Nervous system disorders
Memory impairment
|
9.6%
10/104 • Number of events 14 • 52 weeks
|
5.1%
5/98 • Number of events 5 • 52 weeks
|
|
Nervous system disorders
Tremor
|
1.9%
2/104 • Number of events 2 • 52 weeks
|
11.2%
11/98 • Number of events 11 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
6.7%
7/104 • Number of events 7 • 52 weeks
|
6.1%
6/98 • Number of events 6 • 52 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
6.7%
7/104 • Number of events 8 • 52 weeks
|
5.1%
5/98 • Number of events 7 • 52 weeks
|
|
Metabolism and nutrition disorders
Weight gain
|
8.7%
9/104 • Number of events 9 • 52 weeks
|
6.1%
6/98 • Number of events 6 • 52 weeks
|
|
Infections and infestations
Nasopharyngitis
|
6.7%
7/104 • Number of events 9 • 52 weeks
|
10.2%
10/98 • Number of events 26 • 52 weeks
|
|
General disorders
Fatigue
|
9.6%
10/104 • Number of events 10 • 52 weeks
|
4.1%
4/98 • Number of events 5 • 52 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60