Clinical Trial Results:
A 52 weeks, open-label, multicenter study evaluating the efficacy and safety of gabapentin as adjunctive therapy in pediatric subjects who have completed the 12 weeks treatment in study A9451162.
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Summary
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EudraCT number |
2014-004175-23 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
22 Dec 2010
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Results information
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Results version number |
v1(current) |
This version publication date |
30 May 2016
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First version publication date |
17 Jul 2015
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
A9451165
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00620555 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Pfizer Inc.
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Sponsor organisation address |
235 E 42nd Street, New York, United States, NY 10017
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Public contact |
Pfizer Clinical Trials.gov Call Center, Pfizer Inc, 001 8007181021, ClinicalTrials.govCallCenter@pfizer.com
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Scientific contact |
Pfizer Clinical Trials.gov Call Center, Pfizer Inc, 001 8007181021, ClinicalTrials.govCallCenter@pfizer.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
28 Feb 2011
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
22 Dec 2010
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To evaluate the safety and efficacy of gabapentin in the 52 weeks as add-on therapy in the treatment of pediatric subjects with partial seizures (including secondarily generalized) when other antiepileptics do not provide satisfactory effects.
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Protection of trial subjects |
The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
28 May 2008
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Japan: 65
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Worldwide total number of subjects |
65
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
47
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Adolescents (12-17 years) |
18
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||||||||||
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Pre-assignment
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Screening details |
The study was initiated on 28 May 2008 and completed on 22 Dec 2010. A total of 65 subjects were enrolled in the study. | ||||||||||||||||||||
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Period 1
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Period 1 title |
Overall study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||||||
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Arms
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Arm title
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Gabapentin | ||||||||||||||||||||
Arm description |
Pediatric subjects received gabapentin three times daily for 52 weeks. Subjects aged 3 to 12 years received oral solution based on their body weight and subjects aged 13 to 15 years received gabapentin tablets. The dose was adjusted within the range of maintenance doses. | ||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||
Investigational medicinal product name |
Gabapentin
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Investigational medicinal product code |
CI-945
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Other name |
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Pharmaceutical forms |
Oral solution, Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects aged 3 to 12 years received oral solution (250 milligram(mg)/5 milliliter(mL)) at the dose calculated based on their body weight; 40 milligram/kilogram/day (mg/kg/day) for 3 to 4 years old and 25 to 35 mg/kg/day for 5 to 12 years old but not exceeding 1800 milligram(mg) per day. Subjects aged 13 to 15 years received gabapentin tablet at the dose of 1200 or 1800 mg/day. The dose was adjusted within the range of maintenance doses. Gabapentin could be increased if necessary with the maximum dose of 50 mg/kg/day for subjects aged 3 to 12 years. All subjects could receive gabapentin tablet not exceeding 2400 mg per day.
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Baseline characteristics reporting groups
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Reporting group title |
Gabapentin
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Reporting group description |
Pediatric subjects received gabapentin three times daily for 52 weeks. Subjects aged 3 to 12 years received oral solution based on their body weight and subjects aged 13 to 15 years received gabapentin tablets. The dose was adjusted within the range of maintenance doses. | |||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Gabapentin
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Reporting group description |
Pediatric subjects received gabapentin three times daily for 52 weeks. Subjects aged 3 to 12 years received oral solution based on their body weight and subjects aged 13 to 15 years received gabapentin tablets. The dose was adjusted within the range of maintenance doses. | ||
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End point title |
Number of Subjects With Treatment-Emergent Adverse Events (All Causalities and Treatment-Related) [1] | ||||||||||||||||||||||||||||
End point description |
Any untoward medical occurrence in a subject 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 subject'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. Safety analysis set: All subjects who have received at least one dose of the study drug.
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End point type |
Primary
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End point timeframe |
Up to 53 weeks
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical test was planned to be reported for this endpoint. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||
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End point title |
Response Ratio | ||||||||||||||||||
End point description |
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). 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 subjects who have total number of seizures at each assessment time point.
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End point type |
Secondary
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End point timeframe |
Up to 52 weeks
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Responder Rate | ||||||||||||||||||
End point description |
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). 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 subjects who have total number of seizures at each assessment time point.
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End point type |
Secondary
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End point timeframe |
Up to 52 weeks
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Percent Change in Seizure Frequency | ||||||||||||||||||
End point description |
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). 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 subjects who have total number of seizures at each assessment time point.
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End point type |
Secondary
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End point timeframe |
Up to 52 weeks
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| No statistical analyses for this end point | |||||||||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
52 weeks
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Adverse event reporting additional description |
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. EU BR specific AE tables were generated using latest coding.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
17.1
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Reporting groups
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Reporting group title |
GABAPENTIN
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Reporting group description |
Pediatric subjects received gabapentin three times daily for 52 weeks. Subjects aged 3 to 12 years received oral solution based on their body weight and subjects aged 13 to 15 years received gabapentin tablets. The dose was adjusted within the range of maintenance doses. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
