Trial · NCT00620555
A Phase III Open-Label Extension Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures
NCT00620555, Phase 3, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2011-12-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase III Open-Label Extension Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures. Trials, record NCT00620555. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00620555
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase III Open-Label Extension Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures
- NCT number
- NCT00620555
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 65 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Epilepsies, Partial
- Interventions
- gabapentin
- First posted
- 2008-02-21
- Last updated
- 2021-02-03
- Results first posted
- 2011-12-20
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-Related) | up to 53 weeks | Any untoward medical occurrence in a participant who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events: those which occurred or worsened after baseline. Severe AEs: those which interferes significantly with participant's usual function. An AE resulting in any of the following outcomes, was considered to be a serious adverse event: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. |
| Secondary | Response Ratio | Up to 52 weeks | The Response Ratio calculated by the following equation : Response Ratio = (T minus B) divided by (T plus 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 52-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 of the previous study A9451162 (NCT00603473). |
| Secondary | Responder Rate | Up to 52 weeks | Responder Rate was defined as the percentage of subjects with a 50 percent or greater reduction in the seizure frequency per 28 days for the 52-week treatment period in comparison with the frequency per 28 days for the 6-week baseline period of the previous study A9451162 (NCT00603473). |
| Secondary | Percent Change in Seizure Frequency | Up to 52 weeks | Percent change in seizure frequency (PCH) was calculated as follows: PCH = 100\*(T minus B) divided by 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 52-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 of the previous study A9451162 (NCT00603473). |
Source ClinicalTrials.gov
Outcomes4
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 Treatment-Emergent Adverse Events (All Causalities and Treatment-Related) | up to 53 weeks | Safety analysis set: All paticipants who have received at least one dose of the study drug. | Participants | NUMBER |
| SECONDARY | Response Ratio | Up to 52 weeks | Intent to treat (ITT): Subjects who have received at least one dose of the study drug and in whom the number of epileptic seizures used for efficacy assessment has been counted in both the baseline and treatment periods.~n = number of participants who have total number of seizures at each assessment time point. | Ratio | MEAN |
| SECONDARY | Responder Rate | Up to 52 weeks | Intent to treat (ITT): Subjects who have received at least one dose of the study drug and in whom the number of epileptic seizures used for efficacy assessment has been counted in both the baseline and treatment periods.~n = number of participants who have total number of seizures at each assessment time point. | Percentage of participants | NUMBER |
| SECONDARY | Percent Change in Seizure Frequency | Up to 52 weeks | Intent to treat (ITT): Subjects who have received at least one dose of the study drug and in whom the number of epileptic seizures used for efficacy assessment has been counted in both the baseline and treatment periods.~n = number of participants who have total number of seizures at each assessment time point. | Percent change | MEDIAN |
Source ClinicalTrials.gov
Results by group25
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-Related) | Gabapentin | All-causality adverse events (AEs) | 58 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-Related) | Gabapentin | Treatment-related AEs | 13 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-Related) | Gabapentin | All-causality serious AEs | 2 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-Related) | Gabapentin | Treatment-related serious AEs | 0 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-Related) | Gabapentin | All-causality severe AEs | 1 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-Related) | Gabapentin | Treatment-related severe AEs | 0 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-Related) | Gabapentin | Discontinuation due to all-causality AEs | 4 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-Related) | Gabapentin | Discontinuation due to treatment-related AEs | 2 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-Related) | Gabapentin | Dose reduction due to all-causality AEs | 2 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-Related) | Gabapentin | Dose reduction due to treatment-related AEs | 2 | Participants |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Gabapentin | 65 | |
| Overall Study | COMPLETED | Gabapentin | 44 | |
| Overall Study | NOT COMPLETED | Gabapentin | 21 |
Source ClinicalTrials.gov
Adverse events15
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 | Dental caries | Gastrointestinal disorders | Gabapentin | 5 | 65 | |
| other | Diarrhoea | Gastrointestinal disorders | Gabapentin | 7 | 65 | |
| other | Vomiting | Gastrointestinal disorders | Gabapentin | 4 | 65 | |
| other | Pyrexia | General disorders | Gabapentin | 8 | 65 | |
| other | Bronchitis | Infections and infestations | Gabapentin | 4 | 65 | |
| other | Influenza | Infections and infestations | Gabapentin | 9 | 65 | |
| other | Nasopharyngitis | Infections and infestations | Gabapentin | 28 | 65 | |
| other | Pharyngitis | Infections and infestations | Gabapentin | 4 | 65 | |
| other | Upper respiratory tract infection | Infections and infestations | Gabapentin | 4 | 65 | |
| other | Arthropod bite | Injury, poisoning and procedural complications | Gabapentin | 4 | 65 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 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 | 48 | 65 |
| Total, serious adverse events | Gabapentin | 2 | 65 |
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/NCT00620555
GET https://conductscience.org/api/trials/v1/NCT00620555/results?page=2