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Trial record 1 of 1 for:    A9451165
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A Phase III Open-Label Extension Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures

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ClinicalTrials.gov Identifier: NCT00620555
Recruitment Status : Completed
First Posted : February 21, 2008
Results First Posted : December 20, 2011
Last Update Posted : January 26, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Epilepsies, Partial
Intervention Drug: gabapentin
Enrollment 65
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Gabapentin
Hide Arm/Group Description Pediatric participants received gabapentin three times daily for 52 weeks. Participants aged 3 to 12 years received oral solution (250 mg/5 mL) at the dose calculated based on their body weight; 40 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 mg per day. Participants 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 participants aged 3 to 12 years; All participants could receive gabapentin tablet not exceeding 2400 mg per day.
Period Title: Overall Study
Started 65
Completed 44
Not Completed 21
Reason Not Completed
Adverse Event             4
Protocol Violation             2
Lack of Efficacy             12
Withdrawal by Subject             1
Choice of other treatment             1
Visit failure against planned             1
Arm/Group Title Gabapentin
Hide Arm/Group Description Pediatric participants received gabapentin three times daily for 52 weeks. Participants aged 3 to 12 years received oral solution (250 mg/5 mL) at the dose calculated based on their body weight; 40 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 mg per day. Participants 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 participants aged 3 to 12 years; All participants could receive gabapentin tablet not exceeding 2400 mg per day.
Overall Number of Baseline Participants 65
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 65 participants
3-4 years 8
5-12 years 42
13-16 years 15
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants
Female
27
  41.5%
Male
38
  58.5%
1.Primary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-Related)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: All paticipants who have received at least one dose of the study drug.
Arm/Group Title Gabapentin
Hide Arm/Group Description:
Pediatric participants received gabapentin three times daily for 52 weeks. Participants aged 3 to 12 years received oral solution (250 mg/5 mL) at the dose calculated based on their body weight; 40 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 mg per day. Participants 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 participants aged 3 to 12 years; All participants could receive gabapentin tablet not exceeding 2400 mg per day.
Overall Number of Participants Analyzed 65
Measure Type: Number
Unit of Measure: Participants
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
2.Secondary Outcome
Title Response Ratio
Hide 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).
Time Frame Up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Gabapentin
Hide Arm/Group Description:
Pediatric participants received gabapentin three times daily for 52 weeks. Participants aged 3 to 12 years received oral solution (250 mg/5 mL) at the dose calculated based on their body weight; 40 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 mg per day. Participants 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 participants aged 3 to 12 years; All participants could receive gabapentin tablet not exceeding 2400 mg per day.
Overall Number of Participants Analyzed 65
Mean (Standard Deviation)
Unit of Measure: Ratio
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)
3.Secondary Outcome
Title Responder Rate
Hide 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).
Time Frame Up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Gabapentin
Hide Arm/Group Description:
Pediatric participants received gabapentin three times daily for 52 weeks. Participants aged 3 to 12 years received oral solution (250 mg/5 mL) at the dose calculated based on their body weight; 40 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 mg per day. Participants 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 participants aged 3 to 12 years; All participants could receive gabapentin tablet not exceeding 2400 mg per day.
Overall Number of Participants Analyzed 65
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
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)
4.Secondary Outcome
Title Percent Change in Seizure Frequency
Hide 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).
Time Frame Up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Gabapentin
Hide Arm/Group Description:
Pediatric participants received gabapentin three times daily for 52 weeks. Participants aged 3 to 12 years received oral solution (250 mg/5 mL) at the dose calculated based on their body weight; 40 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 mg per day. Participants 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 participants aged 3 to 12 years; All participants could receive gabapentin tablet not exceeding 2400 mg per day.
Overall Number of Participants Analyzed 65
Median (Full Range)
Unit of Measure: Percent change
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)
Time Frame 52 weeks
Adverse Event Reporting 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.
 
Arm/Group Title Gabapentin
Hide Arm/Group Description Pediatric participants received gabapentin three times daily for 52 weeks. Participants aged 3 to 12 years received oral solution (250 mg/5 mL) at the dose calculated based on their body weight; 40 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 mg per day. Participants 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 participants aged 3 to 12 years; All participants could receive gabapentin tablet not exceeding 2400 mg per day.
All-Cause Mortality
Gabapentin
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Gabapentin
Affected / at Risk (%)
Total   2/65 (3.08%) 
Nervous system disorders   
ENCEPHALOPATHY  1  1/65 (1.54%) 
Respiratory, thoracic and mediastinal disorders   
BRONCHOPNEUMONIA  1  1/65 (1.54%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Gabapentin
Affected / at Risk (%)
Total   48/65 (73.85%) 
Gastrointestinal disorders   
Dental caries  1  5/65 (7.69%) 
Diarrhoea  1  7/65 (10.77%) 
Vomiting  1  4/65 (6.15%) 
General disorders   
Pyrexia  1  8/65 (12.31%) 
Infections and infestations   
Bronchitis  1  4/65 (6.15%) 
Influenza  1  9/65 (13.85%) 
Nasopharyngitis  1  28/65 (43.08%) 
Pharyngitis  1  4/65 (6.15%) 
Upper respiratory tract infection  1  4/65 (6.15%) 
Injury, poisoning and procedural complications   
Arthropod bite  1  4/65 (6.15%) 
Fall  1  4/65 (6.15%) 
Nervous system disorders   
Somnolence  1  10/65 (15.38%) 
Skin and subcutaneous tissue disorders   
Eczema  1  4/65 (6.15%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00620555     History of Changes
Other Study ID Numbers: A9451165
First Submitted: February 11, 2008
First Posted: February 21, 2008
Results First Submitted: November 14, 2011
Results First Posted: December 20, 2011
Last Update Posted: January 26, 2012