Trial · NCT01292837
A Study of Levetiracetam in Japanese Pediatric Patients With Generalized Tonic-clonic Seizures
NCT01292837, Phase 3, Completed, UCB Japan Co. Ltd.; results first posted 2014-08-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Levetiracetam in Japanese Pediatric Patients With Generalized Tonic-clonic Seizures. Trials, record NCT01292837. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01292837
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Levetiracetam in Japanese Pediatric Patients With Generalized Tonic-clonic Seizures
- NCT number
- NCT01292837
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 13 participants, actual
- Lead sponsor
- UCB Japan Co. Ltd.
- Conditions
- Epilepsy, Generalized Tonic-clonic Seizures
- Interventions
- Levetiracetam
- First posted
- 2011-02-10
- Last updated
- 2015-05-15
- Other registries' IDs
- eudract:2014-004382-25
- Results first posted
- 2014-08-12
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Percent Change From the Combined Baseline (4-week Retrospective Baseline and 4-week Prospective Baseline) in the Generalized Tonic-clonic Seizure Frequency Per Week Over the 24-week Treatment Period (Up-Titration and Evaluation Periods) | From Baseline (Week -8) to Treatment Period (Week 0 to Week 24) | The percent change from Combined Baseline over Treatment Period was calculated from the Generalized Tonic-Clonic (GTC) seizure frequency per week during the Treatment Period (T) and during the Baseline Period (B, Combined Baseline, ie, Retrospective and Prospective Baseline Periods) using the equation below. The percent change from Baseline = (B - T)/B x 100 The seizure frequency per week was calculated using the following formula: Frequency per week of GTC seizures = total number of GTC seizures in the corresponding period / number of days for observation in the corresponding period x 7 |
| Secondary | The Percent Change in Generalized Tonic-clonic Seizure Frequency Per Week From the Combined Baseline Period Over the Evaluation Period | From Baseline (Week -8) to Evaluation Period (Week 4 to Week 24) | The percent change from Combined Baseline over Evaluation Period was calculated from the Generalized Tonic-Clonic (GTC) seizure frequency per week during the Evaluation Period (E) and during the Baseline Period (B, Combined Baseline, ie, Retrospective and Prospective Baseline Periods) using the equation below. The percent change from Baseline = (B - E)/B x 100 The seizure frequency per week was calculated using the following formula: Frequency per week of GTC seizures = total number of GTC seizures in the corresponding period / number of days for observation in the corresponding period x 7 |
| Secondary | Generalized Tonic-clonic Seizures 50 % Responder Rate (the Proportion of Subjects With 50 % or More Reduction From the Combined Baseline in the Frequency of Generalized Tonic-clonic Seizures) During the Treatment Period | From Baseline (Week -8) to Treatment Period (Week 0 to Week 24) | The 50 % responder rate during the Treatment Period was the proportion of subjects who reported a ≥ 50 % reduction in seizure frequency per week from Baseline during the Treatment Period. |
| Secondary | Generalized Tonic-clonic Seizures 50 % Responder Rate During the Evaluation Period | From Baseline (Week -8) to Evaluation Period (Week 4 to Week 24) | The 50 % responder rate during the Evaluation Period was the proportion of subjects who reported a ≥50 % reduction in seizure frequency per week from Baseline during the Evaluation Period. |
| Secondary | Generalized Tonic-clonic Seizure Freedom Over the Treatment Period | Treatment Period (Week 0 to Week 24) | A subject with a generalized tonic-clonic seizure frequency of 0 per week throughout the Treatment Period was considered a seizure-free subject for that period. |
| Secondary | Generalized Tonic-clonic Seizure Freedom Over the Evaluation Period | Evaluation Period (Week 4 to Week 24) | A subject with a generalized tonic-clonic seizure frequency of 0 per week throughout the Evaluation Period was considered a seizure-free subject for that period. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Percent Change From the Combined Baseline (4-week Retrospective Baseline and 4-week Prospective Baseline) in the Generalized Tonic-clonic Seizure Frequency Per Week Over the 24-week Treatment Period (Up-Titration and Evaluation Periods) | From Baseline (Week -8) to Treatment Period (Week 0 to Week 24) | The Analysis Population refers to the Full Analysis Set (FAS). The FAS was a subset of the Safety Set and included all subjects with Combined Baseline Period (Retrospective and Prospective) and post-Baseline Generalized Tonic-Clonic seizure counts as the primary efficacy analysis. | percent change | MEAN |
| SECONDARY | The Percent Change in Generalized Tonic-clonic Seizure Frequency Per Week From the Combined Baseline Period Over the Evaluation Period | From Baseline (Week -8) to Evaluation Period (Week 4 to Week 24) | The Analysis Population refers to the Full Analysis Set (FAS). The FAS was a subset of the Safety Set and included all subjects with combined Baseline Period and post-Baseline generalized tonic-clonic seizure counts. 12 of the 13 subjects in the FAS were included in the analysis excluding 1 subject discontinued before the Evaluation Period. | percent change | MEAN |
| SECONDARY | Generalized Tonic-clonic Seizures 50 % Responder Rate (the Proportion of Subjects With 50 % or More Reduction From the Combined Baseline in the Frequency of Generalized Tonic-clonic Seizures) During the Treatment Period | From Baseline (Week -8) to Treatment Period (Week 0 to Week 24) | The Analysis Population refers to the Full Analysis Set (FAS). The FAS was a subset of the Safety Set and included all subjects with Combined Baseline Period (Retrospective and Prospective) and post-Baseline Generalized Tonic-Clonic seizure counts as the primary efficacy analysis. | percentage of participants | NUMBER |
| SECONDARY | Generalized Tonic-clonic Seizures 50 % Responder Rate During the Evaluation Period | From Baseline (Week -8) to Evaluation Period (Week 4 to Week 24) | The Analysis Population refers to the Full Analysis Set (FAS). The FAS was a subset of the Safety Set and included all subjects with Combined Baseline Period (Retrospective and Prospective) and post-Baseline Generalized Tonic-Clonic seizure counts as the primary efficacy analysis.~One subject discontinued the study during the Up-Titration Period. | percentage of participants | NUMBER |
| SECONDARY | Generalized Tonic-clonic Seizure Freedom Over the Treatment Period | Treatment Period (Week 0 to Week 24) | The Analysis Population refers to the Full Analysis Set (FAS). The FAS was a subset of the Safety Set and included all subjects with Combined Baseline Period (Retrospective and Prospective) and post-Baseline Generalized Tonic-Clonic seizure counts as the primary efficacy analysis. | participants | NUMBER |
| SECONDARY | Generalized Tonic-clonic Seizure Freedom Over the Evaluation Period | Evaluation Period (Week 4 to Week 24) | The Analysis Population refers to the Full Analysis Set (FAS). The FAS was a subset of the Safety Set and included all subjects with Combined Baseline Period (Retrospective and Prospective) and post-Baseline Generalized Tonic-Clonic seizure counts as the primary efficacy analysis.~One subject discontinued the study during the Up-Titration Period. | 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 | Category | Value | Spread | Units |
|---|---|---|---|---|---|
The Percent Change From the Combined Baseline (4-week Retrospective Baseline and 4-week Prospective Baseline) in the Generalized Tonic-clonic Seizure Frequency Per Week Over the 24-week Treatment Period (Up-Titration and Evaluation Periods) | Levetiracetam | 45.47 | Standard Deviation 50.34 | percent change | |
| The Percent Change in Generalized Tonic-clonic Seizure Frequency Per Week From the Combined Baseline Period Over the Evaluation Period | Levetiracetam | 44.93 | Standard Deviation 51.86 | percent change | |
Generalized Tonic-clonic Seizures 50 % Responder Rate (the Proportion of Subjects With 50 % or More Reduction From the Combined Baseline in the Frequency of Generalized Tonic-clonic Seizures) During the Treatment Period | Levetiracetam | 53.8 | percentage of participants | ||
| Generalized Tonic-clonic Seizures 50 % Responder Rate During the Evaluation Period | Levetiracetam | 58.3 | percentage of participants | ||
| Generalized Tonic-clonic Seizure Freedom Over the Treatment Period | Levetiracetam | 2 | participants | ||
| Generalized Tonic-clonic Seizure Freedom Over the Evaluation Period | Levetiracetam | 2 | participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Levetiracetam | 13 | |
| Overall Study | COMPLETED | Levetiracetam | 11 | |
| Overall Study | NOT COMPLETED | Levetiracetam | 2 |
Source ClinicalTrials.gov
Adverse events25
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 | Diarrhoea | Gastrointestinal disorders | Levetiracetam | 2 | 13 | 5 |
| other | Nasopharyngitis | Infections and infestations | Levetiracetam | 3 | 13 | 5 |
| other | Convulsion | Nervous system disorders | Levetiracetam | 3 | 13 | 5 |
| other | Somnolence | Nervous system disorders | Levetiracetam | 3 | 13 | 3 |
| other | Dental caries | Gastrointestinal disorders | Levetiracetam | 1 | 13 | 1 |
| other | Stomatitis | Gastrointestinal disorders | Levetiracetam | 1 | 13 | 1 |
| other | Pyrexia | General disorders | Levetiracetam | 1 | 13 | 2 |
| other | Impetigo | Infections and infestations | Levetiracetam | 1 | 13 | 1 |
| other | Otitis media | Infections and infestations | Levetiracetam | 1 | 13 | 1 |
| other | Pneumonia mycoplasmal | Infections and infestations | Levetiracetam | 1 | 13 | 1 |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Levetiracetam | ||
| Total, other adverse events | Levetiracetam | 13 | 13 |
| Total, serious adverse events | Levetiracetam | 0 | 13 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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/NCT01292837
GET https://conductscience.org/api/trials/v1/NCT01292837/events?page=2