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This study is designed to provide short term efficacy and safety data of TRI476 in children with inadequately-controlled partial seizures. Patients will be randomized into either drug treatment or placebo group at 1:1 ratio, and receive their respective treatment for 8 weeks. The purpose of study is to confirm that TRI476 as adjunctive therapy is effective and safe.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRI476 | Experimental | Participants received TRI476 based on body weight with titration up to the maintenance dose, in addition to their traditional antiepileptics dosage. |
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| Placebo | Placebo Comparator | Participants received placebo to TRI476 without any adjustment to the dosing regimen, in addition to their traditional antiepileptics dosage. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRI476 | Drug | TRI476 oral suspension doses, based on body weight twice daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Double-blind Phase, by Treatment Group | Percent change in partial onset seizure frequency per 28 days during the double-blind phase from the screening phase, was calculated according to the following formula: "Percent change in partial onset seizure frequency per 28 days from the screening phase" = (partial onset seizure frequency per 28 days during the double-blind phase - partial onset seizure frequency per 28 days during the screening phase) / partial onset seizure frequency per 28 days during the double-blind phase x 100 "Partial onset seizure frequency per 28 days" = Number of partial onset seizures during each phase (screening phase or double-blind phase) / number of days during the screening or double-blind phase × 28. | screening and 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Partial Seizure Frequency Per 28 Days, by Study Period (Every 28 Days) and Treatment Group | Partial onset seizure frequency per 28 days during a period between baseline and Week 4 was measured. Partial onset seizure frequency per 28 days (count/28 days)" = Number of partial onset seizures during each phase (screening phase or double-blind phase) / Number of days during the phase x 28. | baseline, 28 days and 56 days |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Nagoya | Aichi-ken | 460-0004 | Japan | ||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| Click here for more information about this study: | View source |
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Participants kept same dosage of their traditional antiepileptics prior to screening and throughout the study. They received TRI476 or placebo in a 1:1 ratio. TRI476 dose was increased gradually, based on body weight during the titration period (day 0- 14). The tolerated dose was given during the maintenance period (up to day 56).
A total of 99 patients were randomized, one patient who did not receive study drug was excluded. A total of 48 participants were randomized to TRI476 and 51 to placebo. 7 participants discontinued during the titration period and 3 discontinued during the maintenance period. A total of 89 participants completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | TRI476 | Participants received TRI476 based on body weight with titration up to the maintenance dose, in addition to their traditional antiepileptics dosage. |
| FG001 | Placebo | Participants received placebo to TRI476 without any adjustment to the dosing regimen, in addition to their traditional antiepileptics dosage. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Titration Period |
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| Placebo to TRI476 |
| Drug |
Placebo oral suspension, taken twice daily |
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| Benzodiazepines | Drug | Benzodiazepines could be used as needed as rescue medication during the duration of the study. |
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| Percent of Participants With Response During Double-blind Phase, by Treatment Group | Responder rate was defined as the percent of participants with an at least 50% reduction in partial onset seizure frequency per 28 days from the screening phase. | screening to 28 days |
| Percent Change in Partial Onset Seizure Frequency During the Double-blind Phase by Seizure Type | Percent change in seizure frequency from baseline = 100 (T-B)/B, B=Seizure frequency per 28 days during baseline phase, T=Seizure frequency per 28 days during the double-blind phase. Seizure frequency per 28 days is calculated as: (seizure frequency during the double-blind phase / the number of days the seizure information were provided) x 28. Only patients with both baseline and corresponding post-baseline values are included. | 28 days |
| Number of Participants With Clinical Global Impression of Change (CGIC) at Final Assessment, by Treatment Group | Clinical Global Impression of Change (CGI) is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). CGI-C scores range from 1 (very much improved) through to 7 (very much worse). | 56 days |
| Ohbu |
| Aichi-ken |
| 474-0031 |
| Japan |
| Novartis Investigative Site | Matsuyama | Ehime | 790-8524 | Japan |
| Novartis Investigative Site | Fukuoka | Fukuoka | 814-0180 | Japan |
| Novartis Investigative Site | Gifu | Gifu | 502-8558 | Japan |
| Novartis Investigative Site | Kameda-gun | Hokkaido | 041-1111 | Japan |
| Novartis Investigative Site | Sapporo | Hokkaido | 060-8648 | Japan |
| Novartis Investigative Site | Himeji | Hyōgo | 670-8540 | Japan |
| Novartis Investigative Site | Kobe | Hyōgo | 658-0032 | Japan |
| Novartis Investigative Site | Yokohama | Kanagawa | 244-0842 | Japan |
| Novartis Investigative Site | Kōshi | Kumamoto | 861-1196 | Japan |
| Novartis Investigative Site | Kashiwazaki | Niigata | 945-8585 | Japan |
| Novartis Investigative Site | Niigata | Niigata | 950-2085 | Japan |
| Novartis Investigative Site | Yufu | Oita Prefecture | 879-5593 | Japan |
| Novartis Investigative Site | Kurashiki | Okayama-ken | 710-8522 | Japan |
| Novartis Investigative Site | Okayama | Okayama-ken | 700-8558 | Japan |
| Novartis Investigative Site | Neyagawa | Osaka | 572-0085 | Japan |
| Novartis Investigative Site | Higashimatsuyama-shi | Saitama | 355-0008 | Japan |
| Novartis Investigative Site | Saitama | Saitama | 339-8551 | Japan |
| Novartis Investigative Site | Moriyama-shi | Shiga | 524-0022 | Japan |
| Novartis Investigative Site | Shizuoka | Shizuoka | 420-8688 | Japan |
| Novartis Investigative Site | Shimotsuke | Tochigi | 329-0498 | Japan |
| Novartis Investigative Site | Bunkyo-ku | Tokyo | 113-8431 | Japan |
| Novartis Investigative Site | Yamagata | Yamagata | 990-0876 | Japan |
| Novartis Investigative Site | Chūō | Yamanashi | 409-3898 | Japan |
| COMPLETED |
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| NOT COMPLETED |
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| Maintenance Period |
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| ID | Title | Description |
|---|---|---|
| BG000 | TRI476 | Participants received TRI476 based on body weight with titration up to the maintenance dose, in addition to their traditional antiepileptics dosage. |
| BG001 | Placebo | Participants received placebo to TRI476 without any adjustment to the dosing regimen, in addition to their traditional antiepileptics dosage. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Double-blind Phase, by Treatment Group | Percent change in partial onset seizure frequency per 28 days during the double-blind phase from the screening phase, was calculated according to the following formula: "Percent change in partial onset seizure frequency per 28 days from the screening phase" = (partial onset seizure frequency per 28 days during the double-blind phase - partial onset seizure frequency per 28 days during the screening phase) / partial onset seizure frequency per 28 days during the double-blind phase x 100 "Partial onset seizure frequency per 28 days" = Number of partial onset seizures during each phase (screening phase or double-blind phase) / number of days during the screening or double-blind phase × 28. | The Full Analysis set included all participants who received study drug. | Posted | Mean | Standard Deviation | percentage change per 28 days | screening and 28 days |
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| ||||||||||||||||||||||||||||
| Secondary | Partial Seizure Frequency Per 28 Days, by Study Period (Every 28 Days) and Treatment Group | Partial onset seizure frequency per 28 days during a period between baseline and Week 4 was measured. Partial onset seizure frequency per 28 days (count/28 days)" = Number of partial onset seizures during each phase (screening phase or double-blind phase) / Number of days during the phase x 28. | The Full Analysis set included all participants who received study drug. | Posted | Mean | Standard Deviation | seizures per 28 days | baseline, 28 days and 56 days |
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| |||||||||||||||||||||||||||||
| Secondary | Percent of Participants With Response During Double-blind Phase, by Treatment Group | Responder rate was defined as the percent of participants with an at least 50% reduction in partial onset seizure frequency per 28 days from the screening phase. | The Full Analysis set included all participants who received study drug. | Posted | Number | percentage of participants | screening to 28 days |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percent Change in Partial Onset Seizure Frequency During the Double-blind Phase by Seizure Type | Percent change in seizure frequency from baseline = 100 (T-B)/B, B=Seizure frequency per 28 days during baseline phase, T=Seizure frequency per 28 days during the double-blind phase. Seizure frequency per 28 days is calculated as: (seizure frequency during the double-blind phase / the number of days the seizure information were provided) x 28. Only patients with both baseline and corresponding post-baseline values are included. | Analyzed set includes all participants who received study drug and had both baseline and post baseline data available. | Posted | Mean | Standard Deviation | percentage change in seizure frequency | 28 days |
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| Secondary | Number of Participants With Clinical Global Impression of Change (CGIC) at Final Assessment, by Treatment Group | Clinical Global Impression of Change (CGI) is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). CGI-C scores range from 1 (very much improved) through to 7 (very much worse). | The Analysis set included all participants who received study drug and had data available for analysis. | Posted | Number | participants | 56 days |
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A total of 99 patients were randomized, one patient who did not receive study drug was excluded from the safety analysis set
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TRI476 | Participants received TRI476 based on body weight with titration up to the maintenance dose, in addition to their traditional antiepileptics dosage. | 1 | 47 | 38 | 47 | ||
| EG001 | Placebo | Participants received placebo to TRI476 without any adjustment to the dosing regimen, in addition to their traditional antiepileptics dosage. | 1 | 51 | 27 | 51 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchopneumonia | Infections and infestations | MedDRA | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
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| Conjunctivitis | Eye disorders | MedDRA | Systematic Assessment |
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| Diplopia | Eye disorders | MedDRA | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Otitis media | Infections and infestations | MedDRA | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Head injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Ataxia | Nervous system disorders | MedDRA | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA | Systematic Assessment |
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| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis | 41 61 324 1111 |
| ID | Term |
|---|---|
| D012640 | Seizures |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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