Trial · NCT00807989

The Efficacy and Safety of Low Dose Combination of LTG and VPA Compared to CBZ Monotherapy

NCT00807989, Phase 4, Completed, Yonsei University; results first posted 2015-05-29

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. The Efficacy and Safety of Low Dose Combination of LTG and VPA Compared to CBZ Monotherapy. Trials, record NCT00807989. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00807989

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: The Efficacy and Safety of Low Dose Combination of LTG and VPA Compared to CBZ Monotherapy
NCT number: NCT00807989
Status: Completed
Phases: Phase 4
Enrollment: 207 participants, actual
Lead sponsor: Yonsei University
Conditions: Epilepsy
Interventions: Carbamazepine, Lamotrigine/Valproate
First posted: 2008-12-15
Last updated: 2015-07-27
Results first posted: 2015-05-29

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Retention Rate After 52 Weeks Maintenance Period	52 weeks	\* Retention rate means completion rate (CR), the proportion of patients who have completed the 60-week study as planned.
Secondary	Seizure Free Rate for 24 Weeks at Initial Target Dose	24 weeks
Secondary	Seizure Free Rate for 52 Weeks at Initial Target Dose	52 weeks

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Retention Rate After 52 Weeks Maintenance Period	52 weeks	participants	NUMBER
SECONDARY	Seizure Free Rate for 24 Weeks at Initial Target Dose	24 weeks	participants	NUMBER
SECONDARY	Seizure Free Rate for 52 Weeks at Initial Target Dose	52 weeks	participants	NUMBER

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Retention Rate After 52 Weeks Maintenance Period	Carbamazepine	104	participants
Retention Rate After 52 Weeks Maintenance Period	Lamotrigine/Valproate	98	participants
Seizure Free Rate for 24 Weeks at Initial Target Dose	Carbamazepine	51	participants
Seizure Free Rate for 24 Weeks at Initial Target Dose	Lamotrigine/Valproate	59	participants
Seizure Free Rate for 52 Weeks at Initial Target Dose	Carbamazepine	43	participants
Seizure Free Rate for 52 Weeks at Initial Target Dose	Lamotrigine/Valproate	50	participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Carbamazepine	107
Overall Study	STARTED	Lamotrigine/Valproate	100
Overall Study	COMPLETED	Carbamazepine	104
Overall Study	COMPLETED	Lamotrigine/Valproate	98
Overall Study	NOT COMPLETED	Carbamazepine	3
Overall Study	NOT COMPLETED	Lamotrigine/Valproate	2

Source ClinicalTrials.gov

Adverse events40

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Headache	Nervous system disorders	Carbamazepine	26	104	29
other	Headache	Nervous system disorders	Lamotrigine/Valproate	26	98	52
other	Dizziness	Nervous system disorders	Carbamazepine	18	104	23
other	Dizziness	Nervous system disorders	Lamotrigine/Valproate	17	98	18
other	Somnolence	Nervous system disorders	Carbamazepine	14	104	15
other	Somnolence	Nervous system disorders	Lamotrigine/Valproate	12	98	12
other	Memory impairment	Nervous system disorders	Carbamazepine	10	104	14
other	Memory impairment	Nervous system disorders	Lamotrigine/Valproate	5	98	5
other	Tremor	Nervous system disorders	Carbamazepine	2	104	2
other	Tremor	Nervous system disorders	Lamotrigine/Valproate	11	98	11

1 to 10 of 40Source ClinicalTrials.gov

See all 40 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Carbamazepine
Total, all-cause mortality	Lamotrigine/Valproate
Total, other adverse events	Carbamazepine	60	104
Total, other adverse events	Lamotrigine/Valproate	59	98
Total, serious adverse events	Carbamazepine	9	104
Total, serious adverse events	Lamotrigine/Valproate	0	98

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Carbamazepine vs Lamotrigine/Valproate: Retention Rate After 52 Weeks Maintenance Period	Trial comparisons
Carbamazepine vs Lamotrigine/Valproate: Seizure Free Rate for 52 Weeks at Initial Target Dose	Trial comparisons
Carbamazepine vs Lamotrigine/Valproate: Seizure Free Rate for 24 Weeks at Initial Target Dose	Trial comparisons
Carbamazepine vs Lamotrigine/Valproate: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00807989

GET https://conductscience.org/api/trials/v1/NCT00807989/events?page=2

API reference For AI assistants