Trial · NCT00603473
A Phase III Open-Label Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures
NCT00603473, Phase 3, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2011-02-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase III Open-Label Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures. Trials, record NCT00603473. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00603473
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase III Open-Label Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures
- NCT number
- NCT00603473
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 92 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Epilepsies, Partial
- Interventions
- gabapentin
- First posted
- 2008-01-29
- Last updated
- 2021-02-03
- Results first posted
- 2011-02-21
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response Ratio of Gabapentin in Japanese Pediatric Patients With Partial Seizures | 12 weeks | The Response Ratio calculated by the following equation was assessed as the primary endpoint: R Ratio = (T-B) / (T+B) where T is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 12-week treatment period, and B is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 6-week baseline period. |
| Secondary | Responder Rate | 12 weeks | Responder Rate was defined as the percentage of subjects with a 50% or greater reduction in the seizure frequency per 28 days for the 12-week treatment period in comparison with the frequency per 28 days for the 6-week baseline period. |
| Secondary | Percent Change in Seizure Frequency (PCH) | 12 weeks | PCH calculated by the following equation was assessed as secondary endpoint: PCH = 100 (T-B) / B where T is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 12-week treatment period, and B is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 6-week baseline period. |
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 | Response Ratio of Gabapentin in Japanese Pediatric Patients With Partial Seizures | 12 weeks | Modified intent-to-treat (MITT) population: Subjects who have received the study medication for at least 28 days and in whom the number of epileptic seizures used for efficacy assessment has been counted for at least 28 days in both the baseline and treatment periods. | ratio | MEAN |
| SECONDARY | Responder Rate | 12 weeks | Modified intent-to-treat (MITT) population: Subjects who have received the study medication for at least 28 days and in whom the number of epileptic seizures used for efficacy assessment has been counted for at least 28 days in both the baseline and treatment periods. | Percentage of Subjects | MEAN |
| SECONDARY | Percent Change in Seizure Frequency (PCH) | 12 weeks | Modified intent-to-treat (MITT) population: Subjects who have received the study medication for at least 28 days and in whom the number of epileptic seizures used for efficacy assessment has been counted for at least 28 days in both the baseline and treatment periods. | Percent Change | MEDIAN |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Response Ratio of Gabapentin in Japanese Pediatric Patients With Partial Seizures | Gabapentin | -0.158 | 95% Confidence Interval -0.221 to -0.096 | ratio | |
| Responder Rate | Gabapentin | 19.8 | 95% Confidence Interval 12.0 to 29.8 | Percentage of Subjects | |
| Percent Change in Seizure Frequency (PCH) | Gabapentin | -24.4 | Full Range -100.0 to 192.9 | Percent Change |
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 | Gabapentin | 89 | |
| Overall Study | COMPLETED | Gabapentin | 80 | |
| Overall Study | NOT COMPLETED | Gabapentin | 9 |
Source ClinicalTrials.gov
Adverse events18
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 | Conjunctivitis | Eye disorders | Gabapentin | 3 | 89 | |
| other | Diarrhoea | Gastrointestinal disorders | Gabapentin | 6 | 89 | |
| other | Nausea | Gastrointestinal disorders | Gabapentin | 3 | 89 | |
| other | Pyrexia | General disorders | Gabapentin | 5 | 89 | |
| other | Influenza | Infections and infestations | Gabapentin | 9 | 89 | |
| other | Nasopharyngitis | Infections and infestations | Gabapentin | 24 | 89 | |
| other | Pharyngitis | Infections and infestations | Gabapentin | 6 | 89 | |
| other | Rhinitis | Infections and infestations | Gabapentin | 3 | 89 | |
| other | Upper respiratory tract infection | Infections and infestations | Gabapentin | 4 | 89 | |
| other | Contusion | Injury, poisoning and procedural complications | Gabapentin | 6 | 89 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Gabapentin | ||
| Total, other adverse events | Gabapentin | 73 | 89 |
| Total, serious adverse events | Gabapentin | 1 | 89 |
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/NCT00603473
GET https://conductscience.org/api/trials/v1/NCT00603473/registered