A Phase 3 interventional study of gabapentin in Epilepsies, Partial, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.. Completed at 22 sites in Japan. Open to participants aged 3 Years and older. Per ClinicalTrials.gov, last updated 2021-02-03.
Sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Phase 3, Interventional, and Treatment
Examine the safety and efficacy of gabapentin as adjunctive therapy in Japanese pediatric patients with partial seizures
254 studies on the registry are indexed under Epilepsies, Partial; 48 are open to participants now.
This study's enrollment of 65 is below the median of 87 across 197 interventional studies indexed under Epilepsies, Partial.
Browse Epilepsies, Partial studies →Pfizer's Upjohn has merged with Mylan to form Viatris Inc. is the lead sponsor of 431 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: gabapentin
Orally administered gabapentin
Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-Related)
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.
Time frame: up to 53 weeks
Response Ratio
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).
Time frame: Up to 52 weeks
Responder Rate
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).
Time frame: Up to 52 weeks
Percent Change in Seizure Frequency
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).
Time frame: Up to 52 weeks
| Milestone | Gabapentin |
|---|---|
| Started | 65 |
| Completed | 44 |
| Not completed | 21 |
| Withdrew: Adverse event | 4 |
| Withdrew: Protocol violation | 2 |
| Withdrew: Lack of efficacy | 12 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Choice of other treatment | 1 |
| Withdrew: Visit failure against planned | 1 |
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.
| Participants | Gabapentin |
|---|---|
| All-causality adverse events (AEs) | 58 |
| Treatment-related AEs | 13 |
| All-causality serious AEs | 2 |
| Treatment-related serious AEs | 0 |
| All-causality severe AEs | 1 |
| Treatment-related severe AEs | 0 |
| Discontinuation due to all-causality AEs | 4 |
| Discontinuation due to treatment-related AEs | 2 |
| Dose reduction due to all-causality AEs | 2 |
| Dose reduction due to treatment-related AEs | 2 |
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).
| Ratio | Gabapentin |
|---|---|
| Week 1 to 8 (n=65) | -0.263 ± 0.3141 |
| Week 9 to 16 (n=60) | -0.256 ± 0.3513 |
| Week 17 to 24 (n=58) | -0.300 ± 0.3671 |
| Week 25 to 36 (n=54) | -0.280 ± 0.3753 |
| Week 37 to 52 (n=47) | -0.327 ± 0.3712 |
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).
| Percentage of participants | Gabapentin |
|---|---|
| Week 1 to 8 (n=65) | 35.4 (23.9 to 48.2) |
| Week 9 to 16 (n=60) | 40.0 (27.6 to 53.5) |
| Week 17 to 24 (n=58) | 39.7 (27.1 to 53.4) |
| Week 25 to 36 (n=54) | 40.7 (27.6 to 55.0) |
| Week 37 to 52 (n=47) | 46.8 (32.1 to 61.9) |
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).
| Percent change | Gabapentin |
|---|---|
| Week 1 to 8 (n=65) | -34.2 (-100.0 to 63.1) |
| Week 9 to 16 (n=60) | -33.0 (-100.0 to 99.8) |
| Week 17 to 24 (n=58) | -42.0 (-100.0 to 112.5) |
| Week 25 to 36 (n=54) | -41.6 (-100.0 to 110.7) |
| Week 37 to 52 (n=47) | -49.2 (-100.0 to 131.7) |
Collected over 52 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Gabapentin | — | 2/65 (3.1%) | 48/65 (73.8%) |
| Event | Gabapentin |
|---|---|
| BRONCHOPNEUMONIARespiratory, thoracic and mediastinal disorders | 1/65 |
| ENCEPHALOPATHYNervous system disorders | 1/65 |
| Event | Gabapentin |
|---|---|
| NasopharyngitisInfections and infestations | 28/65 |
| SomnolenceNervous system disorders | 10/65 |
| InfluenzaInfections and infestations | 9/65 |
| PyrexiaGeneral disorders | 8/65 |
| DiarrhoeaGastrointestinal disorders | 7/65 |
| Dental cariesGastrointestinal disorders | 5/65 |
| VomitingGastrointestinal disorders | 4/65 |
| BronchitisInfections and infestations | 4/65 |
| PharyngitisInfections and infestations | 4/65 |
| Upper respiratory tract infectionInfections and infestations | 4/65 |
| Age, Customized(Participants) | Gabapentin |
|---|---|
| 3-4 years | 8 |
| 5-12 years | 42 |
| 13-16 years | 15 |
| Sex: Female, Male(Participants) | Gabapentin |
|---|---|
| Female | 27 |
| Male | 38 |
This study is completed, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.