Trial · NCT00088452

Childhood Absence Epilepsy Rx PK-PD-Pharmacogenetics Study

NCT00088452, Phase 3, Completed, Children's Hospital Medical Center, Cincinnati; results first posted 2020-10-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Childhood Absence Epilepsy Rx PK-PD-Pharmacogenetics Study. Trials, record NCT00088452. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00088452

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Trial

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

Title: Childhood Absence Epilepsy Rx PK-PD-Pharmacogenetics Study
NCT number: NCT00088452
Status: Completed
Phases: Phase 3
Enrollment: 453 participants, actual
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Conditions: Childhood Absence Epilepsy, Petit Mal Epilepsy, Epilepsy, Seizures
Interventions: Ethosuximide, Lamotrigine, Valproic acid
First posted: 2004-07-27
Last updated: 2020-10-14
Results first posted: 2020-10-14
Limitations and caveats: This short-term study was not designed to detect long-term systemic or other cognitive effects of these three medications.

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Number of Participants With Freedom From Treatment Failure at 16-20 Weeks of Double Blind Therapy	First 16-20 weeks of double blind therapy	Treatment failure was defined as persistence of absence seizures at week 16 or week 20, a generalized tonic-clonic seizure at any time, excessive drug-related systemic toxicity, a moderately severe rash (possibly drug-related), pancreatitis, or increase in the body-mass index of at least 3.0 from baseline, dose-limiting toxicity after a single downward dose modification, or withdrawal initiated by the parent or physician.
Secondary	Number of Participants With Attention Deficit as Measured by the Confidence Index of the CPT-II and the K-CPT	First 16-20 weeks of double blind therapy	A Confidence Index of 0.60 or higher on the Conners' Continuous Performance Test at the visit at 16 or 20 weeks or at an earlier visit when treatment was discontinued (as long as the discontinuation occurred 1 month or more after the baseline visit and was not due to intolerable adverse events). A Confidence Index of 0.60 corresponds to a 60% probability that the child has clinical attention deficit disorder.
Secondary	Number of Participants With Freedom From Treatment Failure at 12 Months of Double Blind Therapy	First 12 months of double blind therapy	Treatment failure was defined as persistence of absence seizures at 12 months of double blind therapy, a generalized tonic-clonic seizure at any time, excessive drug-related systemic toxicity, a moderately severe rash (possibly drug-related), pancreatitis, or increase in the body-mass index of at least 3.0 from baseline, dose-limiting toxicity after a single downward dose modification, or withdrawal initiated by the parent or physician.

Source ClinicalTrials.gov

Outcomes3

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Freedom From Treatment Failure at 16-20 Weeks of Double Blind Therapy	First 16-20 weeks of double blind therapy		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Attention Deficit as Measured by the Confidence Index of the CPT-II and the K-CPT	First 16-20 weeks of double blind therapy	Those subject who took the Conners' Continuous Performance Test at the visit at 16 or 20 weeks or at an earlier visit when treatment was discontinued (as long as the discontinuation occurred 1 month or more after the baseline visit and was not due to intolerable adverse events).	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Freedom From Treatment Failure at 12 Months of Double Blind Therapy	First 12 months of double blind therapy		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group9

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

Outcome	Group	Value	Units
Number of Participants With Freedom From Treatment Failure at 16-20 Weeks of Double Blind Therapy	Ethosuximide	81	Participants
Number of Participants With Freedom From Treatment Failure at 16-20 Weeks of Double Blind Therapy	Lamotrigine	43	Participants
Number of Participants With Freedom From Treatment Failure at 16-20 Weeks of Double Blind Therapy	Valproic Acid	85	Participants
Number of Participants With Attention Deficit as Measured by the Confidence Index of the CPT-II and the K-CPT	Ethosuximide	35	Participants
Number of Participants With Attention Deficit as Measured by the Confidence Index of the CPT-II and the K-CPT	Lamotrigine	25	Participants
Number of Participants With Attention Deficit as Measured by the Confidence Index of the CPT-II and the K-CPT	Valproic Acid	52	Participants
Number of Participants With Freedom From Treatment Failure at 12 Months of Double Blind Therapy	Ethosuximide	70	Participants
Number of Participants With Freedom From Treatment Failure at 12 Months of Double Blind Therapy	Lamotrigine	31	Participants
Number of Participants With Freedom From Treatment Failure at 12 Months of Double Blind Therapy	Valproic Acid	64	Participants

Source ClinicalTrials.gov

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Ethosuximide	156
Overall Study	STARTED	Lamotrigine	149
Overall Study	STARTED	Valproic Acid	148
Overall Study	COMPLETED	Ethosuximide	155
Overall Study	COMPLETED	Lamotrigine	149
Overall Study	COMPLETED	Valproic Acid	147
Overall Study	NOT COMPLETED	Ethosuximide	1
Overall Study	NOT COMPLETED	Lamotrigine	0
Overall Study	NOT COMPLETED	Valproic Acid	1

Source ClinicalTrials.gov

Adverse events69

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	Fatigue	General disorders	Ethosuximide	15	155	15
other	Fatigue	General disorders	Lamotrigine	13	149	13
other	Fatigue	General disorders	Valproic Acid	18	147	18
other	Headache	General disorders	Ethosuximide	19	155	19
other	Headache	General disorders	Lamotrigine	12	149	12
other	Headache	General disorders	Valproic Acid	12	147	12
other	Sleep problem	General disorders	Ethosuximide	10	155	10
other	Sleep problem	General disorders	Lamotrigine	5	149	5
other	Sleep problem	General disorders	Valproic Acid	14	147	14
other	Nausea, vomiting, or both	Gastrointestinal disorders	Ethosuximide	23	155	23

1 to 10 of 69Source ClinicalTrials.gov

See all 69 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ethosuximide	0	155
Total, all-cause mortality	Lamotrigine	0	149
Total, all-cause mortality	Valproic Acid	0	147
Total, other adverse events	Ethosuximide	103	155
Total, other adverse events	Lamotrigine	78	149
Total, other adverse events	Valproic Acid	100	147
Total, serious adverse events	Ethosuximide	4	155
Total, serious adverse events	Lamotrigine	2	149
Total, serious adverse events	Valproic Acid	2	147

Source ClinicalTrials.gov

Papers5

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
20200383	RESULT	PubMed
23167925	BACKGROUND	PubMed
26311751	BACKGROUND	PubMed
27986874	BACKGROUND	PubMed
28916534	DERIVED	PubMed

Grants2

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source
U01NS045911	Impact of Initial Therapy and Response on Long Term Outcome in Children with CAE	GLAUSER, TRACY A	CINCINNATI CHILDRENS HOSP MED CTR	NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE	2003 to 2013	NIH RePORTER
U01NS045803	Childhood Absence Epilepsy: Coordinating Center	CNAAN, AVITAL	CHILDREN'S HOSP OF PHILADELPHIA	NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE	2003 to 2008	NIH RePORTER

Trial comparisons0

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

None in this release.

Tests1

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

Test	Named as
Continuous Performance Test	Secondary outcome

Source ConductCognition

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/NCT00088452

GET https://conductscience.org/api/trials/v1/NCT00088452/events?page=2

API reference For AI assistants