A Phase III Open-Label Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00603473

Purpose

Examine the efficacy, safety and pharmacokinetics of gabapentin as adjunctive therapy in Japanese pediatric patients with partial seizures

Condition	Intervention	Phase
Epilepsies, Partial	Drug: gabapentin	Phase III

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open-Label, Multicenter Study Evaluating, The Efficacy, Safety And Pharmacokinetics Of Gabapentin As Adjunctive Therapy In Pediatric Patients With Partial Seizures When Other Antiepileptics Do Not Provide Satisfactory Effects

Resource links provided by NLM:

Genetics Home Reference related topics: autosomal dominant partial epilepsy with auditory features pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy

MedlinePlus related topics: Epilepsy Seizures

Drug Information available for: Gabapentin Gabapentin enacarbil

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Response Ratio of Gabapentin in Japanese Pediatric Patients With Partial Seizures [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
The Response Ratio calculated by the following equation was assessed as the primary endpoint: R Ratio = (T−B) / (T+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 12-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.

Secondary Outcome Measures:

Responder Rate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Responder Rate was defined as the percentage of subjects with a 50% or greater reduction in the seizure frequency per 28 days for the 12-week treatment period in comparison with the frequency per 28 days for the 6-week baseline period.
Percent Change in Seizure Frequency (PCH) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
PCH calculated by the following equation was assessed as secondary endpoint: PCH = 100 (T−B) / 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 12-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.

Enrollment:	92
Study Start Date:	January 2008
Study Completion Date:	December 2009
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: gabapentin	Drug: gabapentin Orally administered gabapentin

Eligibility

Ages Eligible for Study:	3 Years to 15 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Japanese male or females, ages 3-15 years old at acquisition of informed consent, 15 years old or less at the baseline visit
Seizures are classified as simple partial, complex partial or partial becoming secondarily generalized (defined according to the International League Against Epilepsy)
Have not been able to achieve adequate seizure control with antiepileptic drugs

Exclusion Criteria:

Seizures related to drugs or acute medical illness
History of any serious medical or psychiatric disorder
Diagnosis or history of a structural CNS lesion or an encephalopathy shown to be progressive

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00603473

Locations

Japan
Pfizer Investigational Site
Obu-shi,Morioka-machi, Aichi, Japan
Pfizer Investigational Site
Jonan-ku, Fukuoka, Japan
Pfizer Investigational Site
Sapporo, Hokkaido, Japan
Pfizer Investigational Site
Kobe, Hyogo, Japan
Pfizer Investigational Site
Suma-Ku, Kobe, Hyogo, Japan
Pfizer Investigational Site
Kanazawa, Ishikawa, Japan
Pfizer Investigational Site
Zentsuuji, Kagawa, Japan
Pfizer Investigational Site
Yokohama, Kanagawa Pref., Japan
Pfizer Investigational Site
Sendai-shi, Miyagi-ken, Japan
Pfizer Investigational Site
Showa-Ku, Nagoya, Japan
Pfizer Investigational Site
Niigata-shi, Niigata, Japan
Pfizer Investigational Site
Kurashiki-City, Okayama Pref., Japan
Pfizer Investigational Site
Okayama-shi, Okayama, Japan
Pfizer Investigational Site
Izumi-shi, Osaka, Japan
Pfizer Investigational Site
Miyakojima-ku, Osaka, Japan
Pfizer Investigational Site
Suita, Osaka, Japan
Pfizer Investigational Site
Higashimatsuyama, Saitama, Japan
Pfizer Investigational Site
Shizuoka-shi, Shizuoka, Japan
Pfizer Investigational Site
Kiyose-shi, Tokyo, Japan
Pfizer Investigational Site
Kodaira, Tokyo, Japan
Pfizer Investigational Site
Setagaya-ku, Tokyo, Japan
Pfizer Investigational Site
Shinjuku-ku, Tokyo, Japan
Pfizer Investigational Site
Hiroshima, Japan
Pfizer Investigational Site
Saitama, Japan
Pfizer Investigational Site
Yamagata, Japan
Pfizer Investigational Site
Yamanashi, Japan

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Director, Clinical Trials Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00603473 History of Changes
Other Study ID Numbers:	A9451162
Study First Received:	January 16, 2008
Results First Received:	December 6, 2010
Last Updated:	January 24, 2011
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:

Epilepsy
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents

ClinicalTrials.gov processed this record on February 09, 2012